The biopharmaceutical industry has seen exciting advancements in the past decade, with cell and gene therapies, personalized medicine, messenger RNA (mRNA) vaccines, and new treatments for autoimmune diseases. The global biopharma industry is expected to increase at a compound annual growth rate of 8.97% from 2025 to 2030; this growth is suspected to result from a demand for targeted therapies, new alliances, and increased innovation (1). The oncology field is also making an impact, with immunotherapies, cell therapies, and gene therapies advancing quickly (2).

As more and more new modalities reach regulatory approval and enter the market, David Kuntin, CEO and cofounder of Mesenbio, sees the biopharmaceutical market becoming more diverse with a number of highly targeted treatments, such as antibody–drug conjugates (ADCs) and next-generation antibody therapies (e.g., bispecific antibodies) being developed. “Cell and gene therapies (CGTs) are also advancing, though interest in early-stage assets is waning; we can expect more gene therapies for inherited diseases and CAR [chimeric antigen receptors]-T or other cell-based therapies expanding beyond rare cancers into more common conditions, if pricing is something that can be addressed,” Kuntin says. “Messenger RNA-based products will certainly move beyond traditional vaccines—for instance, there is significant effort in mRNA therapeutics for cancer vaccines and protein replacement therapies. Crucially, these modalities won’t exist in isolation. Many will become established alongside traditional biologics. For example, an autoimmune condition might in the future have treatment options ranging from monoclonal antibodies to an mRNA therapy or even a cell-derived product.”

Other approaches, such as extracellular vesicle (EV) therapeutics, are in development and are a promising new class of regenerative or delivery agents, according to Kuntin. “Overall, the future commercial landscape will not be dominated by one modality but characterized by a wide array of therapeutic approaches, each tailored to different medical needs. This rich diversity is exciting and marks a shift toward more personalized and precise medicine; though, it also means our industry must support a broader range of manufacturing and regulatory strategies to bring these treatments to patients.”

“I’m excited to see multispecific antibody- like biologics synergistically block multiple cancer cell survival pathways or help induce immune responses, such as cell-killing we are currently seeing with cell therapies,” Christian Cobaugh, chief scientific officer and founder, Vernal Biosciences, says. “Multispecifics are also offering more favorable target product profiles and potentially better outcomes in oncology.”

Lipid nanoparticles (LNPs) and mRNA have become “derisked,” according to Cobaugh, and the clinical data from LNP-mRNA for gene editing and oncology are impressive. “Most of the 

 gene-editing programs that we see from companies like Intellia, Beam, and Verve rely on LNP-mRNA (plus guide RNA) and can be dosed to effect,” Cobaugh says. “Further, the therapeutic cancer vaccines are another great way to leverage the speed to clinic that mRNA manufacturing offers.”

While a significant number of illnesses will still be addressed by small-molecule drugs, according to Miguel Forte, president, ISCT, board member, ARM, and CEO Kiji Therapeutics, biologics offer the ability to target certain diseases with specificity and mechanism of action. “If a patient has a genetic disease, it is likely that the best approach would be gene therapy,” Forte says. “I would expect cell, and gene-edited cells to play a major role in oncology—as is already the case—and also in autoimmune diseases, in parallel and possible combination with biologics.”

Diversification in the bio/pharmaceutical industry that provides a mix of traditional small-molecule drugs, biologics, and vaccines may drive more targeted therapies and intensify market competition, according to Max Baumann, cofounder, Treehill Partners.

“As we observed in an industry analysis we performed comprising 1200 clinical programs, only a minority of companies currently optimize their development for commercial success,” Baumann says. “Combined with increased segmentation of clinical end markets, this has a significant impact on the return that potential pharmaceutical drug development offers for investors, and absent a clear investment thesis, not all the products we currently see in development will be successful in securing funding to market entry and break-even.”

Innovation often comes at a cost, however, and this must be balanced. While the industry benefits from the cycle of innovation, formulation, and production, says Oury Chetboun, CEO, Seekyo Therapeutics, new drugs also must be cost effective for patients and to develop and produce. “You may have a fantastic drug in the lab which costs a massive amount to be scaled up, but if you can’t get that into a large-scale production or at a reasonable cost, then you can’t do anything,” Chetboun cautions.

Each patient has different needs, and each disease is different; therefore, a mix of formulation and drug delivery methods is needed for optimal treatment, according to Chetboun. Patient adherence is also important, however. Complying with a treatment plan is easier for patients when fewer doses or administrations are required. Side effects may also impact patient adherence, making multiple delivery route options more attractive, suggests Chetboun.

Creative formulation and drug delivery strategies are necessary for new modalities to reach patients, Kuntin says, and he sees less invasive administration as a major trend. Nasal and inhaled formulations for vaccines and antibody therapies might advance, which could target drugs to mucosal tissues. “There is also significant interest in achieving oral delivery of biologics; traditionally, proteins and nucleic acids get digested in the gut, but new techniques like protective coatings, nanoparticle carriers, or special capsule devices are showing promise in allowing antibodies or peptide therapies to be taken as a pill,” Kuntin explains. “While not every biologic will become a tablet, even a few successes in oral biologic delivery would be paradigm-changing for chronic treatments.”

 cell therapies, mostly CAR-Ts and HSCs [host cell proteins], have validated some key mechanisms of action including gene editing. But those therapies are more akin to procedures, and highly invasive and risky ones at that, than they are products. I’m looking forward to advancements in non-viral genetic delivery technologies, such as LNPs and PNPs that can de-target the liver and retarget blood and immune cells to transform these procedures into products that can be dosed to effect.”

Stability and distribution of new modalities is also critical, says Kuntin, with development ongoing to formulate drugs that remain stable at refrigerator temperature or room temperature, therefore removing the need for ultra-cold storage.

“We’re likely to see more use of advanced carriers like lipid nanoparticles, which have already proven their worth in delivering mRNA vaccines and could be refined for other drugs,” Kuntin says. “Looking further ahead, there is exploration of novel delivery vehicles—for example, utilizing extracellular vesicles as a natural means to carry therapeutic molecules to target tissues. EVs in particular could signal a new paradigm in biologic delivery, with production approaches able to be intrinsically integrated into the EV production process.”

Advancements in technology, such as artificial intelligence (AI), machine learning (ML), and digitization, have played a part in the development of new and innovative modalities. The ability to work with large amounts of data and manage processes digitally may accelerate processes and reduce cost, according to Forte. “Importantly though are the opportunities to accelerate development by providing faster data analysis, scenario elaboration, and digital comparison approaches (digital twins) that will overall improve the process and speed of development,” he stresses. AI can also facilitate the exploration of different models and conditions by using digital twins, adds Forte. “In this context, the conditions and requirements for scaling up can be modeled and analyzed, accelerating the process overall,” he notes. 

“In biologics design, for example, machine learning algorithms can suggest modifications to an antibody or protein to improve its efficacy and stability, or even help design novel therapeutic proteins from scratch,” Kuntin says. “This means we can generate and evaluate a wider range of therapeutic options 

 before moving to lab experiments, saving time and resources. I’ve seen cases where an AI model predicts how a change in a molecule’s structure might affect its function or how a particular patient subgroup might respond to a therapy—insights that would have taken much longer to glean through trial and error in the lab.”

According to Cobaugh, AI is also helping design antisense oligonucleotide therapies and locating gene-editing sites. He also sees AI playing a role in predicting and designing antigens for personalized disease treatments.

“We’ve also seen how tools like Alpha-Fold3 are using machine learning to accurately predict the structures of most biomolecules, including proteins and nucleic acids, reducing what used to be a dissertation’s amount of work to a day or two of computing time. Labs, such as the David Baker lab, are now able to take a de novo approach to design completely synthetic proteins with specific functions in mind,” Cobaugh says.

The development pathway can be streamlined by digitization, using advanced data analytics and automation in preclinical research, says Kuntin. “AI-driven analysis helps interpret complex datasets, such as finding patterns in thousands of data points from early safety studies or optimizing formulation conditions for a new modality. In clinical development, digital tools assist in trial design and patient selection—for instance, algorithms can match eligible patients to clinical trial protocols more effectively or predict outcomes using real-world data, which helps in designing smarter trials. Overall, these technologies are accelerating development timelines and helping us make more informed decisions at each step. The end result is a higher probability that truly effective therapies make it through to approval by focusing our efforts on the most promising candidates and approaches.”

Digital technologies can “create a smoother bridge” across discovery and manufacturing, according to Kuntin, with critical factors and ideal settings for production identified faster with fewer errors. AI/ML can then play a bigger role in commercial manufacturing by monitoring production in real time.

Baumann adds that AI/ML can bridge the gap by facilitating tech transfer through digitally capturing and standardizing process knowledge. “This integrated approach supports faster, more reliable scale-up and reduces the risk of costly manufacturing setbacks,” he says. 

“Modern biologics facilities often use advanced sensors and control software that adjust process conditions on the fly, guided by AI models that have ‘learned’ from the development data,” Kuntin says. “This means we maintain consistency between a small lab batch and a large manufacturing batch. I’ve found that even for complex new modalities—like extracellular vesicles—having a strong digital data backbone from R&D through to production makes tech transfer much more seamless. It reduces the risk for surprises during scale-up and helps get therapies from the bench to the patient more reliably and efficiently. I would say, however, that caution must be exercised whenever these tools are used, and to avoid over-reliance on these, as there is a tendency to treat AI solutions as ‘black boxes’—a totally obscured machine with the ability to pump out data—without truly critically evaluating the outputs. There are clear and important distinctions between generative AI approaches and those that use existing data and draw connections and contextualize these into meaningful outputs, and that is a crucial thing to bear in mind when using AI in drug development, especially when interrogating large data sets.”

“There is significant value to be generated in two main areas,” says Bauman, “namely, ‘doing the right thing/development strategy—where AI/ML can be instrumental in identifying and supporting the best strategic direction and avoid mis-steps that may put an entire company on an inferior path—and ‘doing things the right way’/execution of key tasks along the development journey, where error rates can be reduced, equations be better solved, and ultimately better development outcomes be created through aggregating thousands of slightly improved puzzle pieces,” says Baumann.

New biopharma modalities, along with new technology, have given patients new opportunities and provide value to society, according to Forte, and they could lead to advancements in other areas and product types.

Kuntin sees some new modalities becoming established treatment options in the next decade. “Not every new modality will succeed commercially—each must prove not only clinical benefit but also that it can be delivered to patients reliably—but I am optimistic that a good number of them will become staples in the medical toolkit,” says Kuntin. “In my view, we’re seeing a co-evolution: as therapeutic modalities mature, they push the industry to develop new production capabilities, and as manufacturing technology leaps forward, it expands the realm of what therapies can successfully reach patients. The end result is that patients should benefit from a broader range of treatment options, and these will hopefully become more affordable and accessible as manufacturing efficiencies improve. The future biopharma landscape will be defined by this synergy between groundbreaking science and equally innovative manufacturing.”

“The interplay between modality innovation and manufacturing evolution will define the next decade of biopharma, driving both operational excellence and improved patient outcomes. We remain cautious about the current geopolitical environment inflicting fundamental changes to our industry, which range from choice of production location to pricing of the end product and with that affect the commercial attractiveness/viability of geographical markets across the globe,” Baumann says.

1. Grand View Research. Biopharmaceutical Market Size and Trends. 

2. Haigney, S. Emerging Treatments for Cancer. 

BioPharm International. Next-Generation Biotherapeutics

Articles

Development

The quickly evolving development of biopharmaceuticals is impacting innovation in the industry overall.

Advancements in Biopharma Spur Innovation

Efficient and effective delivery of complex and challenging drug substances is an ongoing issue facing developers of modern medicines. Delivery systems must overcome poor solubility and bioavailability while achieving targeted delivery to achieve maximum efficacy with lower doses while also minimizing unwanted side effects. Nanoscale technology is proving to be an attractive solution on all accounts, particularly for realizing targeted delivery into specific types of cells and across biological barriers.

Many of the unique properties of nanoscale delivery systems can be attributed to their small size (< 100 nanometers). At this scale, the surface area/volume ratio is high, leading to unique physical, chemical, and biologic properties. The ability to tune the surface properties of nanomaterials through functionalization further increases their utility for drug delivery, particularly with respect to their targeting capabilities. Nanoscale delivery systems can not only increase the bioavailability of poorly water-soluble drugs; they can also protect sensitive APIs from degradation and, when appropriately designed, remain stable in the bloodstream, allowing long-term sustained release and more consistent pharmacokinetics (1). The greater cellular uptake of nanoscale delivery systems also contributes to improved efficacy and reduced side effects.

Another important advantage of nanoscale delivery systems is the ability to deliver two or more APIs simultane

Nanoscale co-delivery systemsoffer improved performance for combination therapies because they deliver the different drug substances in a homogeneous manner (2). Ideal nanoscale carriers are stable, small, but able to support sufficient drug loading of both hydrophobic and hydrophilic APIs; protect the loaded drug from degradation; are suitably functionalized to exhibit a high binding affinity to target cells/ tissues; and have good biocompatibility.

Many different types of nanoscale delivery systems (e.g., lipidic, polymeric, inorganic, biomimetic) provide opportunities for designing solutions with high specificity for the particular API, disease target, and route of administration. In fact, they support the loading of most types of drug substances, including small molecules, proteins, nucleic acids, and diagnostic agents (1). They can also be customized in support of personalized medicines, and some have been developed that are capable of exhibiting both therapeutic and diagnostic activities (theranostics).

As more information is gained about the benefits of nanoscale delivery systems, researchers are exploring the applicability of a growing variety of nanoscale materials for this purpose (1–3). Nanoparticles have attracted particular attention, including those based on lipids, polymers (natural and synthetic), lipid-polymer hybrids, dendrimers, inorganic materials (metals, magnetic compounds, carbon nanotubes, silica-based systems, etc.). Other nanocarriers include nanocrystals; DNA-based systems; extracellular vesicles such as exosomes, microvesicles, apoptotic bodies, and phagosomes; nanoemulsions; and micelles.

Like any drug delivery technology, nanoscale systems are not perfect solutions and, depending on the particular nanotechnology, have different sets of limitations (1). Some of the nanomaterials used for drug delivery can, if the systems are not designed appropriately, pose toxicity and biocompatibility issues. One example is metallic nanoparticles if they accumulate in the body.

Similarly, while some nanoscale delivery systems can exhibit prolonged lifetimes in the bloodstream, others have short circulation times or can be viewed as foreign materials by the immune system and rapidly cleared. Some nanomaterials may also exhibit unexpected/unpredictable interactions with biological systems that lead to detrimental effects. These uncertainties and complexity of nanoscale drug delivery systems often lead to regulatory challenges.

The development of robust, predictable large-scale manufacturing processes can be a significant hurdle for some nanomaterials/nanoscale delivery systems. In addition, stability during storage can be an issue for some nanoscale systems, requiring careful formulation development. All these challenges tend to lead to high costs for therapeutics and vaccines leveraging nanoscale drug delivery systems.

Highly targeted delivery with nanoscale systems can be achieved using passive or active mechanisms. Passive delivery involves accumulation of the nanoscale system in the targeted cell/ tissue through enhanced permeability and retention (EPR), which is dictated by the shape, size, charge, and other surface properties of the unfunctionalized nanomaterial (4). This approach does not, however, completely reduce delivery to healthy cells, which can result in off-target effects.

Active targeting, meanwhile, is realized through functionalization of the surface of the nanocarrier system to both increase cellular uptake and ensure delivery to specific cells/tissues (4). Ligands are attached to the surfaces of the nanocarriers that have high binding affinity to receptors specific to the target cells. These ligands can include a range of compounds, including antibodies, aptamers, peptides, small molecules, and biomimetic materials such as cell membranes, among others. As an example, nanoscale delivery systems can be functionalized with PD-L1 monoclonal antibodies in anticancer therapies.

The targeting ability of nanoscale systems can benefit treatments for all disease classes, but this capability is of even greater importance in certain applications. Targeting of cancer cells is a major goal in oncology, as traditional systemic treatment result in severe side effects. The ability of nanocarriers to selectively attack targeted tumor cells allows for delivery of higher doses to improve efficacy while reducing cytotoxicity (1).

Therapeutic hyperthermia is a unique treatment made possible by use of nanoparticle delivery systems (1). Once the nanoparticles are localized in the tumor, they are exposed to laser radiation or an applied magnetic field, leading to an increase in temperature sufficient to kill the cancer cells. The improved targeting capability of nanoscale delivery systems also leads to improved activation of immune cells in cancer vaccines.

Nanoscale delivery systems are improving treatments for infectious diseases including human immunodeficiency virus (HIV) due to their targeting ability. Patient adherence with traditional medications is often low due to the high incidence of side effects. The high on-target bioavailability of nanoscale drugs thus has a measurable, positive impact.

Finally, nanoscale delivery systems are also improving the effectiveness of treatments for autoimmune diseases due to their improved targeting capability (1). Nanoparticles have been shown to deliver antigens and immunomodulators to antigen-presenting cells and lymphocytes with high specificity, and thus more efficiency, inducing antigen-specific tolerance 

Lipid nanoparticles (LNPs) have received significant attention in recent years as attractive systems for the delivery of nucleic acids for vaccine applications. Their success was clearly demonstrated with the approval of the two messenger RNA vaccines against COVID-19, according to McDavid Stilwell, CFO with CPTx. He notes, however, that some of the properties that make LNPs useful for vaccine applications (inflammatory behavior) also present substantial hurdles for systemic therapeutic delivery applications that require higher doses and for which adverse inflammation is undesirable.

There are also issues with targeting LNPs away from the liver, Stilwell observes. The field is working hard to overcome cell targeting challenges, but solutions are not expected soon. Stilwell notes that LNPs have now been successfully engineered to target immune cells, and CPTx is using this approach to deliver single-stranded DNA for its in vivo chimeric antigen receptor (CAR)-T development program.

In addition to ensuring targeted specificity and minimal off-target effects, key challenges with LNPs— and nanoscale delivery systems in general—include achieving consistent manufacturing scalability, controlling batch-to-batch variability, overcoming biological barriers (immune recognition, clearance, endosomal escape), and demonstrating robust safety profiles, adds CPTx’s CEO Hendrik Dietz. “Achieving reliable, reproducible, and cost-effective large-scale production remains critical, especially for transitioning from preclinical validation to clinical and commercial stages,” he says.

CPTx believes that DNA nanostructures presenting an immune-silent vector are a better alternative to currently available gene delivery technologies. “These nanocarriers are optimal for precision targeting, programmable drug release, and transient genetic expression, making them valuable for controlled gene editing and transient immunotherapies,” Stilwell contends. The goal, he adds, is to present a delivery solution that is not only technically superior, but that can also be manufactured in a cost-effective fashion.

The single-stranded DNA nanocarriers CPTx is developing are intended to enable direct, targeted in-vivo gene delivery. Scalable, high-purity DNA single- strand synthesis platforms, both for the gene encoding components of the nanoparticles and the helper material needed to build the nanocarriers, have been an important initial focus to ensure manufacturing challenges are not an issue, according to Dietz.

These new DNA nanostructures are precision engineered from therapeutic immune-silent DNA single-strands using a technique known as programmable DNA nanofabrication, uniquely combining precise control over composition and 3D shape, as well as delivery functionality. “The result is precise cell targeting without external carriers, bypassing issues associated with existing delivery technologies such as viral vectors and lipid nanoparticles, including manufacturing hurdles, immunogenicity (in the case of viral vectors), and targeting challenges,” Dietz states.

The DNA nanocarriers “integrate therapeutic payloads and delivery functionality into rationally engineered particles designed to realize episomal, non-integrated gene expression in target cells or tissues with minimal side effects,” Dietz explains. Functionalization in a site-specific fashion with molecular targeting motifs promotes highly selective binding to specific cells or tissues and efficient cellular uptake, he says.

The modular approach also allows for simultaneous delivery of multiple therapeutic gene payloads and/or simultaneous targeting of multiple tissues or cell types, enhancing effectiveness, safety, and control compared to traditional approaches, according to Dietz.

CPTx is currently working to improve the delivery efficiency in various prototypes while also validating safety and efficacy in animal models with the goal of licensing this DNA nanocarrier delivery solution to drug developers with established payload genes and target tissues.

1. Tenchov, R. et al. Transforming Medicine: Cutting-Edge Applications of Nanoscale Materials in Drug Delivery. 

. 2025 19 (4). https://pubs.acs.org/ doi/10.1021/acsnano.4c09566

2. Sun, L. et al. Better Together: Nanoscale Co-Delivery Systems of Therapeutic Agents for High-Performance Cancer Therapy. F

ront. Pharmacol., Sec. Pharmacol. Anti-Cancer Drugs

. 2024 Vol. 15. DOI: 10.3389/fphar.2024.1389922.

3. Li, Y.; et al. A Nanoscale Natural Drug Delivery System For Targeted Drug Delivery Against Ovarian Cancer: Action Mechanism, Application Enlightenment And Future Potential. 

Front. Immunol., Sec. Canc. Immun. & Immunother.

, 2024 Vol. 15. https://doi.org/10.3389/\ fimmu.2024.1427573

4. Fan, L.; Wang, A.; and Shi, D. Targeted Nanoscale Drug Delivery Systems For Melanoma Therapy. 

. 2023 Vol. 86, 104724. https://doi. org/10.1016/j.jddst.2023.104724

Unique surface properties and ligand functionalization provide real advantages.

Achieving Targeted Delivery with Nanoscale Systems

At conferences and trade shows up and down the calendar, bio/pharmaceutical companies take the opportunity to showcase new, updated, or redesigned equipment, responding to not only the latest demands of the market, but also the innovations of competitors. In this interview with 

®, Sheikh Akbar Ali, PhD, general manager and head of Development and Technology for ACG Packaging Materials, reviews the state of equipment innovation, the emerging technologies that are shaping a new standard of efficiency, how global pressures are affecting the supply chain for raw materials, and what options are available to manufacturers who desire to make their processes more sustainable.

 To start, what are some general trends you are seeing in equipment? Smart tools and three-dimensional (3D) printing are two specific areas in which we have observed progress so far in 2025, and artificial intelligence (AI) continues to be a growing factor in all types of processes. What is most in demand at the current time?

 One growing trend in pharmaceutical packaging is the move toward digital and laser printing technologies. Digital, or on-demand, printing is gaining popularity for enabling batch-level information to be printed just before medicines are packed. This supports traceability, eliminates errors, and increases patient safety as well as flexibility, especially in smaller or personalized medicine batches. Laser printing is also emerging, offering a high-energy, ink free alternative for durable and tamper-evident markings. ACG has been investing significantly in AI to develop smarter equipment. As an example, our vision inspection systems are capable of detecting even the slightest manufacturing defects, ensuring only flawless products are produced. The integration of AI has resulted in a quantum leap forward in defect-detection accuracy, particularly for low-contrast product and foil combinations. Also, training these systems now requires minimal human involvement, with the machine continuously learning and refining its performance through deep learning, and improving its own efficiencies incrementally.

 Many companies are taking steps to increase capacity to meet the demands of their customers. Is there a category of equipment that companies are tending toward including in their expansion plans?

 Like many other sectors, pharmaceutical companies are highly attuned to cost efficiency and inventory management. With a growing emphasis on sustainability, they are now equally attentive to the carbon footprint of their products. As a result, packaging companies are focusing not just on capacity building, but on developing capabilities to produce packaging with the lowest possible environmental impact. Particular attention is being given to solvent-free adhesives and sealing lacquers. Coating and laminating lines that accommodate these solvent-free materials are becoming increasingly valuable. Energy efficiency is another major consideration. Technologies that capture waste heat from the process stack and reuse it to reduce overall energy consumption are gaining traction. And the demand for sustainable packaging materials has accelerated the need for advanced blistering lines, and systems that are faster, modular, and reconfigurable with minimal change over time. These innovations enable manufacturers to efficiently handle a variety of eco-friendly materials without compromising on productivity or quality. In addition, companies setting up new production lines or facilities are prioritizing digital and on-demand printing infrastructure. This enables greater operational flexibility and supports compliance with evolving regulatory requirements.

 How have outsourcing relationships and partnerships evolved to meet the manufacturing needs of all concerned—especially given the currently tenuous geopolitical climate?

 Global supply chain disruptions—driven by geopolitical tensions—are significantly affecting raw material sourcing and timely delivery of packaging materials to pharma companies. This creates bottlenecks in both production and delivery. The issue is particularly severe for sustainable materials needed to meet net-zero goals, as these materials are either scarce or unaffordable.

 What about single-use technology? Where do you foresee the next stage of innovation in that area, and how does that align with sustainability goals for the industry?

 In pharmaceutical applications, reusing packaging is not feasible due to contamination risks. Therefore, single use remains the industry standard. However, significant innovation is occurring to align single-use packaging with sustainability goals. Key developments include, firstly, polyvinyl chloride (PVC)- and halogen-free alternatives in thermoforming and cold forming applications, such as thermoform blisters where the PVC is replaced with APET (amorphous polyethylene terephthalate), PP (polypropylene), or PE (polyethylene); cold form blisters where the PVC is replaced with PP, PE, or BOPET (biaxially oriented polyethylene terephthalate), lidding foil where the halogenated primers and heat seal lacquers (HSLs) are replaced with halogen-free alternatives, or universal sealing lacquer instead of specific lacquer for specific sealing layer. A second key development is in the reduction of mass, evidenced by a compact blister where the blister dimension has been reduced to accommodate the increased number of blisters per stroke of the blister line. A third development is in recyclable materials, namely thermoforming material where both the forming and lidding material are made of the same material and can be recycled in existing recycling infrastructure. And the last is in biodegradable and compostable materials—biodegradable PVC, which is certified to degrade faster than the regular PVC, and paper-based blister packs, which are made of certified compostable materials. These developments enhance recyclability, minimize material usage, and offer safer disposal options, bringing sustainability to single-use packaging without compromising either safety or functionality.

 Are there any new, imminent, or expected regulatory changes that companies and their clients should be aware of?

 There is a notable gap in global regulations for alternative sustainable packaging materials. Current standards primarily cover traditional materials like PVC, which hampers the adoption of newer, eco-friendly options. This regulatory vacuum makes it difficult for pharmaceutical companies to switch to sustainable formats, despite technological readiness. Additionally, the European Union (EU)’s Carbon Border Adjustment Mechanism is a pressing concern. It imposes a tax on imported products, increasing the cost of non-EU packaging materials. This may impact pricing and competitiveness for companies like ACG that export into the EU market.

®
Vol. 49, No. 5
June 2025
Pages: 20–21

When referring to this article, please cite it as Lavery, P. How Smart Technology is Helping Reach Sustainability Goals in Drug Packaging. 

Manufacturing

Smart technologies, such as digital and laser printing, incorporated into manufacturing equipment are helping manufacturers align with sustainability goals, according to Sheikh Akbar Ali, general manager and head of Development and Technology for ACG Packaging Materials.

How Smart Technology is Helping Reach Sustainability Goals in Drug Packaging

Biopharmaceutical product development is burgeoning with developments in treatment approaches, chemistries, and vectors giving companies new strategies for targeting disease. Biosimilars continue to build as a sector of this market with an estimated 2025 value in the region of US$42 billion (1). Many other products are also under development with innovative designs in the areas of fusion proteins, antibody drug conjugates (ADCs) and related species, peptides, and oligonucleotides.

No matter the nature of the product under development, one of the single most important factors during that development phase is the analytical characterization of the product. The need to characterize goes beyond the obvious requirement for demonstration of correct structure of the API itself but also demonstrates control of the manufacturing process, assesses impurity profiles, and ultimately feeds back to changes and improvements in the manufacturing process to ensure the best quality product. Characterization data also builds in quality to the product by having that deep knowledge of its structure and compositional profile. A detailed and thorough characterization is required to be presented to regulatory authorities as part of any submission for regulatory approval and marketing authorization.

The expectations for structural analysis are clearly laid out in a guideline published a number of years ago by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). ICH Q6B provides a clear framework for expectations regarding the structural characterization of biopharmaceutical products (2). While the document itself is a quarter of a century old at this point, it is laid out in such a way that relevancy is maintained. It uses terms like “to the extent possible”, thus allowing for methodological developments pushing the ability to detect structural details in ever greater and more precise ways. That being said, it is recognized that an update is due to acknowledge and bring into focus current analytical practices and to align it with other ICH guidelines. This guideline forms the key document referenced by regulatory authority documents that detail structural characterization requirements of biopharmaceuticals. This covers new biotechnologically derived protein, glycoprotein, and peptide products as well as biosimilars (3, 4). So why is ICH Q6B so important, and what does it outline?

Biopharmaceuticals, which are produced either in cellular systems or created through chemical synthesis, are molecules with incredible complexity. They can be orders of magnitude larger than what we may consider basic pharmaceuticals to be and with this increased size comes not only increased complexity but increased ways in which this complexity manifests. One must consider not only the basic linear structure of the molecule but also the three-dimensional (3D) shape, modifications (either wanted or unwanted) that occur on the molecule, and interactions that may occur within and between molecules themselves (e.g., disulfide bridges and aggregation). Also, consideration must be given to impurities that may arise as a result of the manufacturing or purification processes. All these must be investigated to give as a full a structural characterization of the product as possible and also to use the data as a tool to hone the manufacturing process itself to produce the best quality drug possible. ICH Q6B details the aspects of molecular structure for which characterization is expected.

Firstly, and perhaps most importantly, ICH Q6B requires that the primary amino acid sequence of the product (protein or polypeptide) is determined. This is crucial because a recombinant protein or synthesized peptide must have a known and specific amino acid sequence to fulfill its function. No precise methodology is given for how this should be performed, but modern methods of sequencing rely heavily on state-of-the-art mass spectrometry to provide the most complete and accurate data. Depending on the instrument type, mass spectrometers (e.g., quadrupole time-of-flight [Q-TOF] geometry and similar instruments) can generate mass values with very high mass accuracy (low ppm). This high mass accuracy in combination with this type of instruments’ ability to fragment peptides generates precise sequence information.

Proteins are proteolytically digested to peptides using strategies tailored to the protein under investigation. Peptides are separated and analyzed by on-line liquid chromatography–mass spectrometry (LC-MS), and fragmentation data generated are then used to determine peptide and ultimately protein sequence. This is not to say that MS will be able to generate 100% of the sequence coverage. There may be regions of the protein where peptide generation is difficult or fragment ions are weak or ambiguous. In these instances, gas phase sequencing of purified peptides (also known as Edman sequencing) can be performed to sequentially identify amino acids based on their chromatographic elution positions following specific, sequential chemical labeling.

ICH Q6B also requires that the overall amino acid composition of the product is investigated. To achieve this, the relative molar amounts of each amino acid in the product need to be determined. This is typically carried out using relative quantitation of amino acids following acid hydrolysis of the product and chromatographic separation of the released and derivatized amino acids. Comparison to known amounts of standard amino acids allows for accurate quantitation of each amino acid. It is recognized that no single acid hydrolysis condition will be suitable for all amino acids, so this must be taken into account in terms of recoveries of amino acids and if necessary alternate hydrolytic approaches taken.

Both the N- and C-termini of the product are required to be assessed to demonstrate the degree of homogeneity in each case. Post-translational processing may result in changes to the termini (e.g., ragged ends or N-terminal pyroglutamination), and these must be investigated. N-terminal analysis can be performed by gas phase sequencing if there is a free amine group at the N-terminus (e.g., no pyroglutamination or other blocking group), but there is no equivalent analysis for the C-terminus. Therefore, these terminal investigations are often performed as part of the peptide mapping study.

Peptide mapping is one of the most data-rich analyses that ICH Q6B requires. This investigation is, in some ways, associated with the procedure for primary amino acid sequencing discussed previously. However, peptide mapping focuses on mass analysis of proteolytically released peptides and comparison to the expected masses. The use of high-end mass spectrometers that can generate real-time fragmentation data allows a further confirmation of the identity of peptides detected. Peptide mapping generates a wealth of data, because the combination of specific proteolytic digest and on-line LC-MS analysis of the digest products allows not only accurate mass identification of the peptides themselves but also the identification of any post translational modifications (

). These may either be specific to the production process itself (such as pyroglutamination of the N-terminus as is frequently seen in monoclonal antibodies (mAbs) or may be the result of purification processes (such as amino acid oxidation or deamidation events) and may indicate that process change is required. Peptide mapping also generates data that are required for other areas of ICH Q6B, specifically terminal amino acid sequence identification and disulfide bridge analysis. It also identifies glycosylation sites and can be used to assess the degree of glycosylation site occupancy for glycoproteins. It thus fits well into a multi-attribute monitoring workflow.

Disulfide bridges are links formed across a protein chain, or between protein chains, via the side chain thiol groups of the amino acid cysteine. These bridges serve to maintain the correct 3D shape of the molecule and are very precisely formed, such that the same bridges will be formed from the same pair of cysteine residues in each copy of the protein. The disulfide bridges in a protein are required to be identified to confirm that first they are present and secondly that they are correctly formed. The presence of incorrect disulfide bridges is termed “scrambling” and indicates the presence of a misfolded protein population. This population is likely to result in inactive material but could at worst lead to an immunogenic response in the patient or product aggregation. Disulfide bridges can be identified through targeted proteolytic and/or chemical digestion strategies and MS-based analyses and can be seen as akin to peptide mapping, albeit focused specifically on the bridges (

). It is also important to assess for any unbridged cysteine residues.

Many of the biopharmaceutical products on the market today are glycoproteins with mAbs being the most widespread example. For glycosylated products, it is a requirement that the sugar structures of the molecule (known collectively as glycosylation) are thoroughly characterized. This requires a quantitative analysis of the individual monosaccharides in the glycans (which can be performed by gas chromatography [GC]-MS or LC with fluorescence detection for sialic acids), but most significantly the overall glycan profile must be investigated. This usually involves release of the glycans, and either fluorescent labeling and analysis by on-line LC-MS with fluorescence detection (

) or MS analysis of released glycans following chemical derivatization, depending on the type of glycan being analyzed. This process allows the relative abundances of each glycan to be assessed along with the identification of each glycan’s composition through mass values detected.

To be able to fully define their structures, the linkages between the monosaccharides must also be characterized. Linkage analysis can be performed through a series of elegant chemical steps culminating in GC-MS analysis of the end products. The elution positions and fragmentation patterns identify the original linkage and type of each monosaccharide. Knowing the biosynthetic pathways of glycosylation along with the data generated, it is then possible to define the population of glycans on the product to the extent possible. ICH Q6B also requires that, for glycoproteins with more than one glycosylation site, the glycan profile at each site must also be characterized. Glycosylation is not a templated post-translational modification (PTM) and can be highly heterogenous, depending on the glycoprotein. A detailed knowledge of glycan biosynthesis is needed to fully interpret the data and define the glycan structures indicated by the data.

Modern MS instruments have very high mass accuracy and resolution, allowing an accurate assessment of the molecular weight of the intact product and associated heterogeneity (low ppm). It not only provides data related to the size of the molecule but also may provide orthogonal data supporting other primary assessments of key molecular characteristics including post-translational modifications. Analysis under various conditions (e.g., native [

], reduced, and/or following deglycosylation) allows for an assessment of the overall product mass as well as individual protein chains in multimeric species and protein chains in the absence of glycan heterogeneity.

The MS data should be used alongside data from more traditional methods such as sodium dodecyl sulfate polyacrylamide gel electrophoresis (SDS-PAGE) (or its more modern capillary-based equivalent of capillary electrophoresis-SDS) and size-exclusion chromatography (SEC) when compiling a robust characterization package, to generate orthogonal data sets. With their technical and methodological improvements, advanced techniques provide valuable information on overall product mass profiles. With properly designed experiments, these analyses provide data that will be indicative of the quality of the manufacturing process and the product itself.

Charge isoform analysis provides a profile of species within the sample based on separation of the various charge states. There are many structural attributes within a protein that can affect the charge profile, the most frequently encountered being the post-translational modification deamidation, the presence of sialic acid in glycoproteins, or in the case of monoclonal antibodies (mAbs) the presence of pyroglutamate or heavy chain C-terminal lysine.

ICH Q6B notes the isoform pattern can be assessed using isoelectric focusing or other appropriate techniques. Frequently the capillary-based technique of image capillary isoelectric focusing (icIEF) is used due to its speed, resolution, reproducibility, and reliability of UV and fluorescence-based detection for relative quantitation. Data generated gives charge profile information, which can be further investigated using specific sample treatments prior to reanalysis. This is another area where collection of orthogonal data builds a thorough understanding of the product. For example, charge-based PTMs detected during peptide mapping or glycan analysis experiments may give rise to unique isoform profiles. Along with isoelectric focusing, ion-exchange chromatography can be used to assess isoforms as well as chromatographic patterns.

It is vital to be sure of the amount of product being administered to ensure patient safety and for product bioassay data generation. A common UV absorption reading can be used to measure protein content. When this strategy is applied, it is critical to determine the extinction coefficient. This determination can be achieved using a combination of ultraviolet-visible spectroscopy spectrophotometry and optimized amino acid analysis that has been assessed specifically on the product to demonstrate its suitability. Very often this encompasses a qualification or validation of the method to ICH Q2(R2) specifications (5,6).

Some aspects of structural characterization requirements specified by ICH Q6B overlap with one another. In the case of electrophoretic patterns for example, the same icIEF and CE-SDS experiments applied under the headings of size and/or isoform patterns can be used to provide the required data on identity, homogeneity, and purity for the characterization dossier that this analytical section covers.

The identity, homogeneity, and purity of biologic products needs to be evaluated, and this can be carried out using a variety of chromatographic techniques. The most commonly employed are reverse-phase, SEC, and ion exchange chromatography, each evaluating a different physicochemical characteristic of the molecule. As with other characterization assays, additional or substitute methods such as HIC or HILIC (hydrophilic interaction chromatography), can be used to enhance knowledge and understanding of the product depending on its structural characteristics. Several chromatographic techniques are expected to be applied to separate out components based on different physical properties such as charge, hydrophobicity, and mass. This gives the most comprehensive investigation into the overall composition of the sample because any coeluting species in one technique will likely separate in others.

Spectroscopic techniques are applied during characterization to assess the higher order (secondary and tertiary) structure. The 3D shape of a biological product plays a critical role in its function and therefore must be characterized to the extent possible. The higher order structures of molecules can be composed of different types of structural features, depending on the nature of the primary amino acid sequence and how it interacts with itself in its solution environment to produce the final 3D shape. At the secondary structural level, ordered structural features such as alpha helices or beta sheet structures can be produced, depending on the amino acid sequence, but regions of more random-type structure can also be found. How these secondary structural units interact with one another and assemble in three dimensions gives rise to the tertiary level of molecular structure. Various techniques should be applied during characterization, each of which has its own relative strengths and will thus probe the structure in different and orthogonal ways. The techniques of circular dichroism (CD), Fourier transform infrared spectroscopy (FT-IR), fluorescence analysis, microfluidic modulation spectroscopy (MMS) and nuclear magnetic resonance (NMR, both 1D and 2D) are all appropriate for higher order structural (HOS) analysis and provide a meaningful orthogonal dataset (7).

An assessment of aggregation is important as part of an investigation into product related impurities, which is also covered by ICH Q6B. Orthogonality is again important here and the application of two techniques such as SEC-multi-angle light scattering (MALS) (a column-based method, 

) and SV-AUC (a non-column-based method), which work on different physical principles, gives meaningful data.

The ICH Q6B guidance document has been adopted by regulatory agencies due to its comprehensive coverage of structural requirements both for the product itself but also for impurities found within it. These in-depth characterization studies must be performed during product development and following significant process changes and are expected to be present in any drug application document.

The nature of biologically produced biopharmaceuticals inevitably results in some level of heterogeneity that must be assessed and for which techniques must be used that can provide clear and detailed analytical data. Researchers who follow the suggested guidelines outlined in ICH Q6B, using state-of-the-art analytical equipment and techniques, will be well-positioned to move their product through the regulatory processes and also for critically assessing the production process itself.

Mordor Intelligence. Biosimilars Market Size | Industry Growth & Forecast Report. Mordorintelligence.com (accessed May 5, 2025).

ICH. Specifications. Q6B. Test Procedures and Acceptance Criteria for Biotechnological/Biological Products (ICH, March 1999).

FDA. Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations, Draft Guidance for Industry (CDER, CBER, 2019).

EMA. Guideline on Similar Biological Medicinal Products Containing Biotechnology-derived Proteins as Active Substances: Quality Issues (revision 1) (May 22, 2014).

ICH. Q2(R2). Analytical Validation (ICH, 2023).

Easton, R.L. Structural Characterization Methods for Biosimilars: Fit-for-Purpose, Qualified, or Validated. GaBI J., 2022 11, 41-44

Greer, F and Easton, R.L. Biosimilars–Increasing Regulatory Focus on Orthogonal Analytical Characterization. International Biopharmaceutical Industry, 2021 4, 10-13.

Richard Easton, PhD, is Technical Director–Structural Analysis, BioPharmaSpec Ltd, and Christopher Ziegenfuss is Vice President, at BioPharmaSpec, Inc.

®
Volume 49, No. 5
June 2025
Page: 22–28

When referring to this article, please cite it as Easton, R. and Ziengenfuss, R. ICH Q6B for Analytics. Pharmaceutical Technology 2025 49 (5).

Analytics

ICH Q6B provides expectations and a clear framework for the structural characterization of biopharmaceutical products. 

ICH Q6B for Analytics

The role of contract development and manufacturing organizations (CDMOs) is at an inflection point at the midpoint of the 2020s, mainly taking into account the impacts of two seismic factors: geopolitical shifts, driven in large part by the tariffs enacted in the first several months of United States President Donald Trump’s second term, and the seemingly omnipresent prevalence of artificial intelligence (AI).

The versatility provided by CDMOs is, by necessity, changing with the times. At the Drug, Chemical & Associated Technologies Association (DCAT) Week 2025, India-based Shilpa Medicare said it was launching a newly formed, full-service, “hybrid” CDMO aiming to serve both small- and large-molecule customers in addition to peptides, with a therapeutic specialization in oncology (1,2). Shilpa said the hybrid model would adopt a dual approach: offering comprehensive discovery, clinical, and commercial outsourcing services, but also including commercially ready, “off-the-shelf” novel formulations for business-to-business licensing.

In April 2025, a new CDMO, Meribel Pharma Solutions, was announced to be headquartered in the United Kingdom (3,4). The creation of this mid-sized CDMO was made possible by an acquisition of Synerlab Group, another CDMO, combined with the securing of seven manufacturing sites in Europe formerly belonging to Recipharm. The new company offers 10 manufacturing sites and three drug development services sites in France, Spain, and Sweden, and has established centers of excellence in drug development, lyophilization, preservative-free multidose technologies, and flexible stick-pack and sachet production, meant to support both human and veterinary health products while operating under stringent global regulatory certifications.

One initiative that had been announced prior to the start of 2025 was Thermo Fisher Scientific’s Accelerator Drug Development service, described at the time of its October 2024 launch as the company’s 360° CDMO and contract research organization (CRO) drug development solutions (5). In January 2025, Lyndra Therapeutics, of Watertown, Mass., announced a strategic collaboration with Thermo Fisher leveraging the Accelerator Drug Development platform and allowing Lyndra to use Thermo Fisher’s end-to-end, advanced pharmaceutical manufacturing capabilities based out of Cincinnati, Ohio, to manufacture commercial materials at scale (6,7).

This partnership is indicative of a current trend toward custom, specialized relationships based on specific needs—in this case, Lyndra’s long-acting oral therapies including its lead investigational product, oral weekly risperdone (LYN-005)—rather than a more generalized shared-services approach. Even with that, or perhaps because of it, new concepts like the “hybrid” CDMO are emerging with more frequency. And the presence of artificial intelligence (AI) and a push for smart and/or automated technologies to pick up more and more of the work are all contributing to the shifting landscape.

®’s Drug Digest video series, Adi Kaushal, director and Technology Head of Bioavailability Enhancement at Lonza, discussed the growing preference in the market for oral solid dosage (OSD) forms, like Lyndra’s candidate, and how CDMOs can leverage their experience in performing much-sought-after expert techniques to improve OSD bioavailability to meet demand.

“CDMOs like Lonza are important partners for the smaller biotechs and emerging biotechs, and that is really driven by the experience and the expertise that CDMOs bring to the table, especially for smaller companies that may not have that experience in that space,” Kaushal said (8). “Alongside that, what comes into the picture is investment into state-of-the-art facilities and equipment, which is essential for the manufacture of a lot of these drug products. And then the final part is the regulatory knowledge and the technical knowledge that the CDMOs bring to the drug development process, partnering with the smaller biotechs. That’s really important, because the regulatory landscape is ever-changing, and it is often inherently linked to the technology in question. And so that technology expertise and regulatory expertise, from a regulatory standpoint or compliance standpoint, [are] critical to the progression of molecules into real therapies, and commercializing those.”

What these myriad areas of expertise can potentially result in, according to Kaushal, is a watertight, seamless partnership at any point of the drug product lifecycle that is desired.

“For the smaller biotechs and emerging biotechs, it’s important to partner with CDMOs such as Lonza that can work all along the value chain and can provide an end-to-end offering,” he said (8). “That’s really the key that we have seen in terms of preserving the knowledge, or building on the momentum, that you develop early on in the drug development process and then, keeping that knowledge all the way to be able to commercialize.”

®’s coverage of CPHI Americas, held in Philadelphia from May 20–22, 2025, Christy Eatmon, global subject matter expert for Sterile Drug Products at Thermo Fisher, talked about the progress made in the company’s Accelerator Drug Development offering since the fall 2024 launch, but also offered her perspective on the role of CDMOs in the industry in general.

It’s not just about partnerships between companies, Eatmon said. The connection goes further and deeper.

“I think in the past, CDMOs functioned as ‘just the hands,’ just a manufacturing house. Now we really want to partner with our customers,” she said (9).

And, she added, if those customers are using AI, companies should logically be keeping up.

“We want to be the trusted partner, the team that’s bringing innovation to the market. We have added some aspects of AI to our processes,” Eatmon said. “One of those to know, especially on the drug product side, is that we’ve integrated AI-assisted inspection. This is for large-scale commercial programs right now, but basically, we have a module where we’ve been able to decrease rejects, improving our yields, and then also using very expedited, very fast automated visual inspection—as every serial product, every unit, needs to be inspected, either by person, manually, or automated by a system of cameras.”

One usually thinks of AI as improving efficiency, but contrary to what examples from some platforms in everyday life have shown, in pharmaceutical operations, Eatmon said AI can be a boost to accuracy as well.

“This AI can actually make a huge library of potential defects and can actually go through those defects very quickly, to predict whether something the camera sees that may or may not be a defect is truly a defect,” she said (9). “We’re [also] using AI in other ways, like predictive modeling, which we’ve used for solid dose in the past. Now we’re looking to implement that for sterile products as well, to predict shelf life and things like that. So, I know pharmaceuticals [are] not always cutting-edge with things like AI, but we’re trying to implement where possible.”

The Shilpa Medicare example of a “hybrid” CDMO was just one instance of how companies are redefining not only their partnerships with each other, but also their definitions of what they themselves offer. In 

 eBook, John Tomtishen, senior vice president and general manager of the IDMO business at Cellares, discussed the industry’s long-awaited incorporation of Industry 4.0 concepts, including the novel model appearing in his job title: the IDMO, or integrated development and manufacturing organization (10).

“As the name implies, this includes fully integrated smart manufacturing facilities for true end-to-end scale,” Tomtishen said (10). “It relies on flexible manufacturing capabilities without requiring changes to hardware, meaning process modifications are entirely managed through software. As a result, technology transfer between smart facilities in any geography is streamlined through the leverage of platform standards. Combined, these aspects will make it easier to scale cell therapies globally and meet total patient demand.”

However, Tomtishen said, not just any company can call themselves an IDMO for a new spin on an old acronym. There are certain standards which must be met and maintained.

“The tenets of the IDMO concept can be viewed from the top down: manufacturing facilities must be standardized and interconnected; technology within each smart factory must ensure end-to-end integration; and the platform technologies themselves must be robust enough to serve multiple functions,” he said (10).

Cellares’ IDMO services primarily deal with easing patient accessibility to cell and gene therapies (CGTs), but the principles at the heart of the idea are universal.

“Ultimately, the promise of the IDMO is to accelerate access to life-saving cell therapies for all patients in need,” Tomtishen said (10). “Patients are not concerned about how their drug is manufactured, so long as it is safe, efficacious, affordable, and available when they need it. As such, the IDMO model is well positioned to solve the CGT bottlenecks. This will allow therapeutic developers to focus on what truly matters to their patients and not the manufacturing process, which will further drive drug development innovations across therapeutic indications.”

Whether there will be another abbreviation to come for these partner companies, perhaps working AI into the formation of letters, is a development that is yet to be seen, but one which might not be too far in the future. For now, though, outsourcing models are trending in more specified, more automated, and more customer-focused directions, keeping in mind that the pathway that gets treatments to patients with an optimal combination of safety and efficiency is the preferred path to take.

1. Lavery, P. Shilpa Medicare Launches ‘Hybrid CDMO’ at DCAT Week 2025. 

, March 17, 2025.
2. Shilpa Medicare. Shilpa Launches ‘Hybrid CDMO’ at DCAT. Press Release. March 11, 2025.
3. Lavery, P. New CDMO Meribel Pharma Solutions Launches with 13 Sites in Europe. 

, April 16, 2025.
4. Meribel Pharma Solutions. Meribel Pharma Solutions Launches with Big Ambitions to Elevate Pharma Services to New Heights. Press Release. April 15, 2025.
5. Lavery, P. Thermo Fisher Launching New CDMO, CRO Services at CPHI Milan. 

, Oct. 8, 2024.
6. Lavery, P. Lyndra, Thermo Fisher to Partner on R&D for Long-Acting Oral Therapies. 

, Jan. 15, 2025.
7. Lyndra Therapeutics. Lyndra Therapeutics Announces Strategic Clinical Research and Commercial Manufacturing Services Collaboration with Thermo Fisher Scientific for Long-Acting Oral Therapies. Press Release. Jan. 15, 2025.
8. Lavery, P. Drug Digest: Patient Preference Drives Solid Dosage Trends. 

, May 22, 2025.
9. Lavery. P. CPHI Americas 2025: The Evolving Role of the CDMO. 

, May 28, 2025.
10. Tomtishen, J. Ushering in Industry 4.0 with the IDMO Model to Solve the CGT Manufacturing Bottleneck. 

®
Vol. 49, No. 5
June 2025
Pages: 30–32

When referring to this article, please cite it as Lavery, P. Market Demands and Emerging Technologies Shape Outsourcing Models. 

Outsourcing

Trends in certain forms of drug delivery, as well as the emergence of artificial intelligence, are playing roles in evolving the nature of partnerships, but there are new types of partnerships gaining steam as well.

Market Demands and Emerging Technologies Shape Outsourcing Models

Matt Cushing, VP of Quality and Science, Nelson Labs, and Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs Company, discuss PDA/ANSI Standard 06-2025: Assessment of Quality Culture Guidance Documents, Models, and Tools, which was published in February 2025.

Q: How can the new document from the Parenteral Drug Association (PDA), PDA/ANSI Standard 06-2025, help manufacturers and laboratories improve their culture and processes?

A: PDA/ANSI Standard 06-2025 is a consolidation of guidance documents, tools, and models to assess and improve quality culture. Companies have probably seen how the state of the quality culture can impact an organization positively or negatively. This document is a great tool to research the key aspects of culture, assess the status of your culture, and create a strategy to maintain and improve the quality culture of your organization.

Q: What is a quality culture and what does the term refer to?

A: Quality culture is something seen and felt everyday as an employee and as a consumer in our everyday lives. It is hard to put into words, but it is defined well in the PDA/ANSI 06-2025 standard as “the overriding attitude, both expressed and implied, of an organization towards quality” (1).The document breaks it down into two distinct elements: a culture of shared values, beliefs, expectations, and commitment toward quality and a structural/managerial element with defined processes that enhances quality and coordinates individual efforts. It is the cross-functional ownership of quality at all levels, as well as the beliefs and systems that drive our actions each day.

Q: What factors of a quality culture are important in the pharmaceutical industry?

A: The document has so much information on the key factors of a good quality culture.The consistent themes that stand out are:

Leadership commitment—quality accountability, recognition, feedback loop, Gemba, visionary, strategic, enablers, respect your team, humility, trust

Employee engagement and ownership—mission focused, striving for excellence

Consistent standards and expectations —all sites, all teams aligned and striving for the same outcome, courage to do what is right, communicate the behaviors that you expect

Collaboration and communication—together, sharing, learning from each other, planning

Technical excellence—which was a newer way to group concepts that companies are familiar with, such as mature systems, competence, organizational learning, technology/innovation, and agility.

Q: Can you talk about the application of these factors in a laboratory setting and how it may differ from that of a manufacturer?

A: All of the above attributes apply and are critical for a laboratory’s quality culture, but in the authors’ opinion, some items are even more critical for a testing laboratory to succeed.In a laboratory, the main resource is people, not machines or facilities. Scientific competence and a good understanding of why things are done a certain way is paramount to producing quality results and solving problems for customers. Good leadership and employee engagement can make a huge impact on quality culture and the results achieved for clients.

Q: To what extent is the customer perspective incorporated into quality decision making?

A: The customer perspective must be embedded in strategic planning, quality systems, and day-to-day activities. The customers’ product end-users, along with their regulators, determine what good quality looks like in any particular setting. If contractors are not viewing their work through their clients’ eyes, they will miss the mark on quality. Aligning employees’ responsibilities with customers’ expectations, particularly in the pharmaceutical industry, creates employee engagement as they get excited about what customers are doing. This also creates partnerships with customers that are based on achieving mutual success. What customer doesn’t want to be understood by the provider to whom they are going for a solution?

PDA/ANSI Standard 06-2025: Assessment of Quality Culture Guidance Documents, Models, and Tools

Matt Cushing, VP of Quality and Science, Nelson Labs, and Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs Company.

When referring to this article, please cite it as Cushing, M. and Schniepp, S.J. Guidance on Quality Culture Standards. 

Ask the Expert

Guidance on Quality Culture Standards

Progress in biopharmaceutical science is happening at a pace that challenges even the most seasoned professionals to keep up. This issue of Pharmaceutical Technology® brings that momentum into sharp focus, offering readers a roadmap through scientific breakthroughs, operational innovation, and the cultural shifts required to deliver tomorrow’s medicines.

Our cover story, “Advancements in Biopharma Spur Industry-Wide Innovation,” looks at how messenger RNA platforms, cell and gene therapy pipelines, multispecific antibodies, and extracellular vesicle therapeutics are reshaping the commercial landscape. Thought leaders predict a future in which no single modality dominates; instead, diverse targeted options will coexist, forcing manufacturing and regulatory models to evolve quickly.

Building on that science, the Development feature, “Achieving Targeted Delivery with Nanoscale Systems,” details how lipid, polymeric, and biomimetic nanocarriers are boosting bioavailability and enabling combination therapies.

Downstream on the factory floor, our Manufacturing Q&A with ACG Packaging Materials’ Sheikh Akbar Ali, PhD, illustrates how digital printing techniques, solvent-free adhesives, and advancements in single-use packaging are helping manufacturers meet productivity goals and prioritize sustainability.

As always, quality and compliance remain front and center. Our Pharma Fundamentals feature, “ICH Q6B for Analytics” translates the quarter-century-old guideline into today’s high-resolution mass spectrometry workflows, clarifying expectations for primary sequence confirmation, glycan profiling, and disulfide mapping. Meanwhile, the Outsourcing feature delves into how artificial intelligence and “hybrid” contract and development organzanizations are redefining sponsor relationships amid geopolitical supply chain pressures.

This issue’s Ask the Expert series dives into the PDA/ANSI Standard 06-2025, offering practical advice for embedding leadership accountability, employee engagement, and technical excellence into an enterprise-wide quality culture.

Together, these articles underscore a central message: success in 2025 demands not only cutting-edge science, but agile operations and a values-driven culture that keeps quality at its core.

Mike Hennessy Jr is Chairman and CEO of MJH Life Sciences®.

When referring to this article, please cite it as Hennessy, M. Driving Advancement Through Scientific and Operational Innovation. 

From the CEO

Scientific breakthroughs, operational innovation, and cultural shifts are driving tomorrow’s medicines.