Advances in manufacturing for new biotherapeutics and small-molecule pharmaceuticals are often based on current trends and/or changes or upgrades in equipment and processes. As biotherapeutic modalities grow more complex and as API dosing forms increasingly aim for high potency/low dose formats, equipment and process trends must keep pace. An exploration of current trends in equipment and processes can shed light on how these changes are supporting the way bioprocessing and pharmaceutical manufacturing is advancing going forward.

Starting early in the manufacturing lifecycle, the challenges associated with bioprocess development for a new biotherapeutic can fall into a few major categories. For one, in bioprocess development today, more than ever, there is a need for bioprocesses to be well aligned with the manufacturing supply chain and distribution strategy that is intended for that product right from the get-go, says Smriti Khera, PhD, global head of life sciences strategy and marketing at Rockwell Automation.

“If you look at the industry today, there are two parallel but opposing mega trends. One is that the manufacturing scales needed today are very different across various drug classes,” Khera says.

The bioprocess development for follow-on drug candidates, she emphasizes, “… willoptimize process to boost yield and productivity of the manufacturing process and that might require increased use of automation and evaluating new digital tools and technologies such as digital twins, PAT [process analytical technology] solutions, and beyond. An increased use of automation will produce efficiencies across the process, plant, and personnel needed to support the large scale manufacture of blockbuster drugs,” Khera says.

The more traditional challenges in bioprocess development are around determining and monitoring set points for critical process parameters (CPPs) and critical quality attributes (CQAs). “To do this, [bioprocess developers] need to perturb and evaluate the design space around a process and get a better understanding of the process overall, and that will help them ultimately put a better process and control strategy together,” Khera observes.

CPPs can be dramatically different at different scales, so maintaining conditions correctly, such as homogeneity, temperature, and dissolved oxygen, can be very different at different scales and must be monitored. “Determining the right conditions is [typically] a very labor-intensive process within bioprocess development,” notes Khera. “If you put that into context of today’s extremely diverse and massive therapeutic pipelines, it creates a resource constriction and massive demand for the process development experts’ time. That’s where a big opportunity exists today to leverage available data and science together through mechanistic and data-driven machine learning (ML) models and be able to run process simulations to help cut down on the manual experiments and expensive pilot runs needed.”

In terms of key equipment, there are a variety of critical equipment applications in biotherapeutic manufacturing, including single-use bioreactors, cell culture equipment, viral vector production systems, purification systems, fill/finish equipment, and real-time analytics gathering, says Anthony Christopher, commercial manager of bioprocessing at Kent Elastomer Products (KEP).

Christopher emphasizes that one of the most prominent recent developments in the biomanufacturing space is the increased adoption of single-use technologies (SUTs). “Advances in disposable components and equipment in a range of applications can help to reduce contamination risks, streamline cleaning requirements, and enable faster changeovers,” he states.

Christopher points to tubing, specifically, which presents one of the critical applications for single-use systems. However, alternatives to traditional silicone tubing offer potential quality and cost optimization benefits that Christopher says can make a true impact on biopharmaceutical manufacturing operations. “Bioprocessors have the opportunity to evaluate and source high-performing elastomeric tubing options that can help bring overall costs down without sacrificing quality or accuracy issues,” he states.

“Elsewhere,” Christopher adds, “we’re monitoring other evolutions, including continuous manufacturing systems, modular production units, integrated chromatography systems, advanced sensor and monitoring systems, and more.”

Meanwhile, automation has been playing a big role in advancing the equipment supporting bioprocessing. Christopher highlights digital twin technology, integrated control systems, automated sampling and analysis, and smart bioreactors as some of the automation developments being witnessed in the biomanufacturing space.

Automation is also being increasingly used at a commercial level. “From what our team has seen, most commercial biomanufacturing processes are partially automated, with automation implemented in upstream (e.g., bioreactors, feeding systems) and downstream (e.g., chromatography, filtration) steps,” says Christopher. He interjects that manual intervention is needed for setup, troubleshooting, and quality control, but that many facilities now use automated systems for data collection, process monitoring, and quality assurance. “But,” he qualifies, “full end-to-end automation is rare.”

On the small-molecule manufacturing front, the pharmaceutical industry is seeing a paradigm shift in processing equipment, driven by automation, sustainability, and regulatory compliance, says Caterina Funaro, Competence Center manager at IMA Active. Industry 4.0, for example, is accelerating the adoption of smart machinery, interconnected sensors, and artificial intelligence (AI)-driven control systems, which are enabling real-time monitoring and data-driven decision-making.

“Predictive maintenance is a key application where equipment can self-monitor for wear and tear and alert operators before a breakdown occurs, minimizing downtime. Smart factories are becoming a reality, where data collected from machines optimize operations in real time,” Funaro states.

Meanwhile, sustainability is a key focus in the pharmaceutical industry as manufacturers face pressure to adopt more energy-efficient equipment that reduces their environmental footprint, notes Funaro. “This includes reducing water and energy consumption, lowering emissions, and improving waste management. Recyclable and reusable components in machinery, as well as the use of environmentally friendly materials, are becoming more widespread,” she observes.

When it comes to developing a manufacturing process for new biotherapeutics, process engineers and, in general, drug developers can benefit from implementing automated technologies into the manufacturing process.

“As an automation engineer,” says John Hatzis, global life sciences industry consultant at Rockwell Automation, “I’m always thinking about tech transfer from process development into GMP [good manufacturing practice] manufacturing, and it’s important to use automation technologies that can make that transition easy.”

“It’s all about leveraging industry standards out-of-the-box so as to avoid the need to reprogram the system or retrain personnel when your therapy gets approved,” Hatzis explains. “If you adopt an automation platform that applies standards [such as] ISA-101 and ISA-88 earlier in your manufacturing, you can seamlessly transition your operations into GMP without costly retraining of personnel or re-architecting your automated systems. Having the features built into the platform that can be easily configured to comply with the regulations for data integrity when you need them is really important.”

For example, Hatzis points out, a developer that builds up a repertoire of automation software for a piece of equipment that does not have “off-the-shelf” features may need to undergo significant reworking when the time comes for tech transfer into a clinical manufacturing, where data integrity becomes crucially important. “All of these things are going to be really important to make tech transfer easy and efficient [going] into clinical or GMP manufacturing,” he states.

Nicolas Pivet, vice-president and general manager, Manufacturing Capacity & Digital Solutions, Cytiva, shares the company’s experience in working with partners to develop bioprocesses for new biotherapeutics. “What we’ve been experiencing is that many of our customers actually use a platform approach for process development, which is great for speed but sometimes is not optimized for everything,” he explains, noting that it was this gap between speed and optimization that prompted Cytiva to develop a software simulation tool (GoSilico). “[This tool] helps to characterize and optimize large sets of chromatography resins, for instance, and saves a lot of time,” says Pivet.

Pivet also brings up the automation layer, which is a layer that allows equipment information to be viewed together. “Over the past seven years,” he explains, “we’ve been developing [an] automation offering (Figurate), which is a wide range of automation solution and libraries—from historian to control systems with Unicorn [control software] to SCADA [supervisory conrol and data acquisition] with Wonderware [automation platform] and to distributed control systems [e.g., DeltaV, PlantPax].”

Developing an automation library for cell culture and purification steps and improving control over CPPs such as pH, oxygen, and temperature, enables parallel processing, which can ease scale-up from lab to production, Pivet explains. Meanwhile, applying automation to downstream chromatography and filtration steps helps optimize product purification, improving purity and yield.

The improvement in process PAT has also been key in the implementation of automation in bioprocessing, Pivet notes. “Today, it’s really about outlier technologies that are used in the industry—[Raman] spectroscopy with chromatography and mass spectrometry [for example]—to monitor product quality, but those solutions have been quite cumbersome on the [manufacturing] floor, so we are working on new and breakthrough technologies [as well as] simulation[s] to avoid the burden of physical experiments,” Pivet says.

Pivet also notes that in-silico process development tools are a game changer. For example, he discusses the development of a bioreactor scaler using computational fluid dynamics capabilities, which helps with scaling up or scaling down between processes. “We’ve shown that we can save up to 50% of the time to run characterization optimization studies, and we can also achieve up to five points higher yield. Truly, I think that automation benefits the whole workflow, the operations—from seed production … to [cell] harvesting and downstream processing, even fill/finish,” he explains.

Furthermore, PAT enhances monitoring at “moments of truth,” where critical control points impact drug quality, safety, and efficacy, Pivet also explains. Integration with manufacturing execution systems and laboratory information management systems ensures full process visibility.

Automation technologies, including PAT, are important now and will be crucial to the industry moving forward. “I think, in the area of process analytical technology, the industry needs to move faster. [Regarding] PAT sensors [for example], there’s the emergence of improved sensing technology. And measuring CQAs, for instance, in line or online is really the holy grail of the biopharma industry right now, so the industry needs to get there in being able to measure CQAs in line and helping with real-time release, or right-time release, of the drug,” Pivet states.

“At the end, we need a software orchestration to take all those sensor data, manage them in real-time, and, using artificial intelligence [AI]/ML modeling, drive a real closed-loop optimization of the batch to end up with a batch that’s prescriptive, where you can really intervene on the batch before it’s too late and maximize the outcome of the batch. So, that’s where the industry is going,” Pivet concludes.

Meanwhile, Christopher observes that, from the research his company’s team has performed and from what is being seen among the customer base, “fully automated commercial-scale biologics manufacturing is not yet common, but the industry is rapidly moving in that direction.”

He points to advances in robotics, AI, and ML accelerating progress. “But, plenty of challenges stand in the way, including cost of implementation, regulatory compliance, and more.We have heard from experts who anticipate that fully automated, ‘lights-out’ biomanufacturing facilities could become a reality within the next five to 10 years,” Christopher adds.

In small-molecule pharmaceuticals manufacturing, automated production lines minimize downtime, increase throughput, and enable continuous manufacturing. “Automated material handling, packaging, and processing reduce the need for human intervention, leading to faster cycle times. In continuous manufacturing—especially in pharmaceuticals and chemicals—automation enables uninterrupted processes, reducing the need for manual batch handling and improving scalability,” says Funaro.

“As automation becomes more advanced,” Funaro adds, “the workforce will need new skills in data analysis, robotics operation, and AI systems management. Upskilling employees to work alongside advanced automation systems will be critical.”

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Vol. 49, No. 2
March 2025
Pages: 10–13

When referring to this article, please cite it as Mirasol, F. Accelerating Adoption of Smart Tools to Advance Manufacturing. 

Articles

Cover Story

Industry 4.0 is driving adoption in the pharma industry for smart equipment 
and tools that will advance manufacturing.

Accelerating Adoption of Smart Tools to Advance Manufacturing 

The requirements for uniformity of dosage units using large sample size data collected and analyzed from process analytical technology (PAT) processes can be met by applying either 

) <1099> Limit on Number of Large Deviations When Assessing Content Uniformity in Large Samples or 

.) 2.9.47 Uniformity of Dosage Units Using Large Sample Sizes. However, both methods are designed to detect the number of dosage units falling outside the specification range of 75–125% of the label claim (% LC) to determine whether these numbers do not exceed the predetermined values based on the sample size.The ‘full tolerance coverage method’ is introduced as a coverage estimation approach for assessing the uniformity of dosage units from large sample sizes, ensuring that no dosage unit exceeds the specification range.

) <905> Uniformity of Dosage Units (UDU; using small sample sizes) (1), the acceptance value (AV) limits are statistically adjusted (95% coverage) (2) and reintroduced in (3; Figure 1). However, a key weakness is that the AV result does not adequately describe the specific characteristics of UDU. To address this limitation, the application and use of tolerance intervals are extensively discussed in the article,“Using Tolerance Intervals to Assess Conformance to Requirements” (4).

To address the small gaps between the calculated tolerance intervals and specification ranges, the upper and lower tolerance limits (UTL and LTL) are set at 115% and 85% label claim (LC), respectively. The tolerance coverages above and below the mean are estimated and summed to obtain what is called “full tolerance coverage” (FTC), yielding a value close to 100%. Because the sample mean is directly used, larger sample sizes provide a more accurate batch mean estimate. Therefore, the FTC method is more practical and suitable for assessing UDU data in production batches, particularly those monitored through process analytical technology (PAT) instrumentation.

Pramote Cholayudth, cpramote2000@yahoo.com, is the founder and manager of PM Consult. He is an industrial pharmacist with more than 40 years of experience. He is a guest speaker on process validation to industrial pharmaceutical scientists organized by Thailand’s FDA.

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Vol. 49, No. 2
March 2025
Pages: 18-23

When referring to this article, please cite it as Cholayudth, P. Full Tolerance Coverage Method for Assessing Uniformity of Dosage Units with Large Sample Sizes. 

Peer-Review Research

The ‘full tolerance coverage method’ is introduced as a coverage estimation approach for assessing the uniformity of dosage units from large sample sizes, ensuring that no dosage unit exceeds the specification range.

Full Tolerance Coverage Method for Assessing Uniformity of Dosage Units with Large Sample Sizes

Addressing the challenges posed by the limited bioavailability of many small-molecule APIs and the instability and inability of nucleic acids to pass through cell membranes has become an important goal within drug development. Most efforts have focused on finding delivery systems that enhance stability and solubility, facilitate cellular entry, and ideally allow effective targeting of specific cells, tissues, and/or organs. Nanoparticle systems, with their small size, high surface areas, and adjustable functionality have attracted significant attention (1).

Most prominent systems to date have been lipid nanoparticles (LNPs), which have been shown to be effective for the delivery of RNA and DNA. LNPs have their own limitations, however, which is driving interest in the development of other nanoparticle delivery systems, including both inorganic and organic alternatives. Three organic options with real potential include exosomes, polymeric nanoparticles, and DNA-based nanoscale frameworks.

While LNPs are currently the go-to solution for delivery of nucleic acids, there is significant room for higher-performing alternatives, as LNPs face several limitations that impact their effectiveness as drug-delivery systems, according to Grant Boldt, chief operating officer at CPTx and gxstrands.

These issues include poor stability, a limited loading capacity for drug substances, manufacturing process scale-up challenges, and the small number of approved lipid excipients available for LNP formulation, notes Tom Tice, senior director global strategic and technical marketing for parenteral drug delivery with Evonik Health Care.

LNP instability is of particular concern. “LNPs can potentially be unstable during storage, leading to drug leakage,” Boldt observes. They are also subject to rapid clearance from circulation, reducing their bioavailability.

In addition, LNPs suffer from challenging extrahepatic delivery, says Davide Zocco, head of exosomes development at Lonza. Specifically, intravenously injected LNPs are mostly absorbed by the liver, with limited exposure to other tissues. “While new lipid chemistries have been developed to facilitate extrahepatic delivery, no (successful) clinical data have been reported yet,” he says. Furthermore, achieving effective endosomal escape and intracellular delivery remains a significant challenge, limiting the successful release of therapeutic cargo into target cells, Boldt adds.

Other challenges highlighted by Zocco include limited activation of mucosal immunity required for successful intranasal administration of vaccines, risk of unwanted immunogenic reactions, and limited evidence of the ability of LNPs to deliver other drug substances such as proteins.

The advantages of nanoscale delivery systems have led to significant efforts to identify other forms of nanoparticles without the limitations associated with LNPs. FDA guidance (2) considers nanomaterials, such as nanoparticles, as materials with dimensions within the nanoscale range of approximately 1nm to 100nm or outside the nanoscale range (up to < 1000 nm) if they exhibit properties or phenomena that are attributable to their dimensions, Tice observes. Alternative inorganic and organic solutions are under investigation. Leading inorganic nanoparticle technologies include those based on gold, iron oxide, and mesoporous silica nanoparticles, as well as quantum dots.

Organic options include extracellular vesicles such as exosomes; polymeric nanoparticles such as dendrimers, polyplexes, and polymersomes; DNA nanostructures; self-assembling peptides; and virus-like particles (VLPs).

While polymeric and inorganic NPs are synthetic, exosomes are produced by cells, and their molecular composition varies depending on the cell source, according to Zocco. Their potential as delivery vehicles is, adds Tice, primarily based on their ability to mimic important cellular interactions and signaling. Exosomes also, notes Boldt, leverage their natural origin and tissue tropism for targeted and biocompatible delivery. DNA origami and other DNA nanostructures, meanwhile, provide precise structural control, programmability, and multifunctionality for advanced therapeutic payloads, Boldt says.

Polymeric nanoparticles are, says Tice, among the leading organic technologies with demonstrated utility in the clinic. Most notable are those based on polymers already used as excipients in drug formulations, particularly bioabsorbable, biocompatible poly(lactide-co-glycolide) polymers (LG polymers), and poly(ethylene glycol) (PEG)/LG polymer copolymers (diblock polymers). Typically, polymeric nanoparticles are designed for drug targeting and to be taken up by cells such as T-cells or the spleen for immunotherapy, Tice adds. In addition, they can provide immediate release or extended release of their active ingredients.

Dendrimers, with their highly branched architecture, enable efficient drug encapsulation and controlled release, Boldt comments. He also notes that self-assembling peptides are gaining attention for their ability to form stable and versatile nanostructures, and VLPs are of interest because they mimic the efficiency of viral delivery while avoiding infectious risks.

“These technologies offer unique and complementary properties, enabling tailored solutions for specific therapeutic applications and enhancing the potential for effective and targeted drug delivery,” Boldt concludes.

Exosomes, observes Zocco, are nanoparticles naturally produced by cells to maintain cell homeostasis (e.g., disposal of molecules) and communicate with other cells through material transfer or surface receptor-mediated signaling (kiss and run mechanism). “As a result,” he says, “they can be exploited to deliver drugs to specific tissues across biological barriers and, given their physiological role, with a lower risk of triggering adverse immune reactions as compared to other organic or inorganic nanoparticles.”

Development of exosomes as drug delivery vehicles does present some challenges, though. Given the high heterogeneity of exosomes, critical quality attributes (CQAs) of exosome-based drugs are not clearly defined, and companies need to proactively engage with regulatory bodies to define their path toward clinical development and commercialization, according to Zocco.

In addition, the development of analytical technologies to characterize exosome-based drugs is an ongoing effort (e.g., single-particle analysis), and as yet no single technology has been generally adopted to address CQAs. “As a consequence,” Zocco notes, “acceptance criteria ranges may change depending on the chosen technology. Furthermore, most analytical technologies have been developed for exosome characterization, with only a handful of them supporting qualified assays for quality control in good manufacturing practice (GMP) manufacturing.”

There is also a lack of expertise in, and scalable processes for, the scalable manufacture of exosomes, according to Zocco. This issue is further exacerbated by the fact that most developers establish their own exosome manufacturing processes using specific cell sources (and media), and no exosome manufacturing platform (and cell source) has been widely accepted yet.

Finally, unlike LNPs for which delivery of nucleic acids has been effectively demonstrated, loading of exosomes with this type of drug substance has proven challenging. “While surface linking with antiSense oligonucleotides and small-interfering RNAs has been demonstrated, luminal loading via electroporation or other means has been largely unsuccessful. Cell engineering strategies or alternative technologies for post-production loading are required to advance the field further,” Zocco concludes.

Despite the challenges, exosomes are still an exciting and innovative drug delivery system, Zocco believes. “While it’s likely that exosomes will not replace LNPs or other nanoparticles any time soon, they may provide a valid alternative to developers that are willing to solve the challenges and benefit from their natural ability to deliver molecules designed to improve health and treat disease,” he concludes.

Lonza’s EngX drug delivery system, which achieves surface and luminal loading of therapeutic molecules into exosomes via linkage to the expressed proteins prostaglandin F2 receptor inhibitor in the EWI (glutamine-tryptophan-isoleucine) immunoglobulin superfamily and brain-abundant membrane-attached signal protein 1 in the myristoylated alanine-rich C-kinase substrate protein family, respectively, is one example of an exosome technology being investigated in clinical trials. Other companies employ similar approaches with exosome shuttle proteins mediating active loading into exosomes, according to Zocco. “Using these systems, efficient loading of large proteins (e.g., gene-editing elements), nucleic acids (e.g., messenger RNA), and even viruses (e.g., adeno-associated viral vectors) has been demonstrated.”

Lipid nanoparticles can include liposomes (lipid vesicles that have at least one lipid bilayer with or without a PEG lipid) and lipid vesicles without a lipid bilayer and comprising multiple lipids, including a PEG lipid and an ionizable lipid designed to deliver messenger RNA. Compared to these LNPs, LG polymer nanoparticles, which have a wide range of tunable properties and performance qualities, can better meet the needs of today’s new modalities, according to Tice.

LG polymer tuning includes manipulation of polymer molecular weight, lactide/glycolide ratio for hydrophobicity tailoring, and end-group structures, says Tice. Nanoparticles made with PEG/LG polymers, meanwhile, have PEG molecules oriented on their surfaces to which various molecules can be attached to increase targeting properties and/or active ingredients.

Compared to LNPs, LG polymeric nanoparticles can support higher drug loading levels and release drugs over longer periods, Tice observes. In addition, they do not require self-assembly and can be produced using more controlled and scalable processes, such as emulsion-based continuous nanoencapsulation. They are also simpler than LNPs, requiring a single polymer excipient, and can be lyophilized and stored at refrigerator temperatures.

As with other technologies, there are some challenges to using polymeric nanoparticles for drug delivery. Tice highlights encapsulation of water-soluble drug substances with high encapsulation efficiencies as potentially presenting difficulties. However, the tunability of polymeric nanoparticles often makes it possible to overcome this issue by modifying the polymer properties and developing an appropriate and optimized manufacturing process. He also notes that optimal processes often help address any scaling challenges, with typical batch sizes for clinical trial materials ranging from 1 to 10 kg.

Ongoing research is also leading to further progress with polymeric systems designed to mimic the biological compatibility and complexity of therapeutic mechanisms of action, and particularly those that can serve as alternatives to lipid-based drug delivery systems, according to Tice. “The goal is to combine the biological performance advantages of lipid-based systems with the process and manufacturing advantages of polymer-based drug delivery systems,” he states.

One of the newest organic nanoparticle technologies in development involves the use of DNA-based nanostructures, which Boldt believes offer distinct advantages for drug delivery due to their highly programmable and customizable structures. “DNA-based nanoparticles are biocompatible, biodegradable, and allow precise control over size, shape, and ligand display, enabling targeted and efficient delivery,” he states.

As importantly, DNA-based nanoparticles can carry multiple therapeutic payloads and demonstrate improved cellular uptake and endosomal escape capabilities, according to Boldt. In fact, DNA nanostructures provide superior structural control and multifunctionality compared to other organic options, offering enhanced adaptability for complex therapeutic needs, he says. “Furthermore, compared to alternatives, they exhibit very low immunogenicity and can be easily modified chemically for targeting or payload attachment,” Boldt notes.

Boldt concludes that given their high biocompatibility, minimal toxicity, and biodegradability, DNA-based systems represent a promising platform for the delivery of advanced, personalized, and genetic medicines. In particular, CPTx believes DNA nanostructures are ideally positioned to serve as a versatile and effective next-generation solution in genetic medicines.

Given the nascent nature of this technology, DNA-based nanoparticle delivery systems not only offer exciting opportunities for innovation and progress, but also present many hurdles to commercial development that require specialized expertise in DNA manufacturing and manipulation as well as drug development in general.

For instance, Boldt notes that nuclease degradation in biological fluids and rapid clearance from circulation presents initial challenges that are being addressed with ongoing advancements in stabilization techniques and delivery strategies. Efforts underway to development enhanced cellular uptake and overcome endosomal entrapment are also proving to be promising. Potential immunogenicity issues, meanwhile, are being overcome through sophisticated design approaches, ensuring safer therapeutic use. Regulatory validation is also a necessary step, but one that represents an opportunity to establish robust standards that will facilitate broader adoption across the industry, according to Boldt.

“By overcoming these challenges, the immense potential of DNA-based nanoparticles as a transformative platform for drug delivery can be fully realized, opening doors to more precise, effective, and personalized medical treatments,” Boldt states.

CPTx is one of only a few companies at the forefront of DNA-nanoparticle-based drug development and working to realize its potential. The company is focused initially on the development of DNA nanostructures for targeted self-gene delivery to specific cell and tissue types. “Our innovative approach leverages the delivery of genes as single-stranded DNA (ssDNA) vectors, offering remarkably low immunogenicity and enabling the potential for repeat dosing—an exciting leap forward for applications like in vivo chimeric antigen receptor T-cell therapies,” Boldt explains.

Proprietary technologies needed to achieve successful scale-up and meet rigorous regulatory requirements for clinical and commercial therapies have already been established, according to Boldt. In particular, CPTx’s processes for production of ssDNA strands and nanoscale DNA frameworks for drug delivery applications allow for efficient, economically viable manufacturing at the large scales needed to meet the demands of several high-impact unmet medical needs. Advanced analytical methods have also been developed to ensure safety, efficacy, and compliance throughout the regulatory process and address the challenges associated with introduction of novel modalities.

Big expectations for nanoscale organic delivery technologies

In the near term, LNPs are expected to remain a preferred option for nanoparticle-based drug delivery. The unique properties of alternative systems, including exosomes, polymeric nanoparticles, and DNA-based nanoscale frameworks, offer the potential for improved performance over LNPs for many drug substances and therapeutic applications, including cancer, autoimmune and infectious diseases, inflammatory conditions, and genetic disorders (1).

Rumiana Tenchov. Nano-sized Drug Delivery Systems Can Treat Cancer, HIV, and More. Chemical Abstracts Service Insights, August 30, 2024.

Guidance for Industry: Drug Products, Including Biological Products, that Contain Nanomaterials

Cynthia A. Challener, PhD, is a contributing editor to 

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Vol. 49, No 2
March 2025
Pages: 14–17

When referring to this article, please cite it as Challener, C.A. Organic Nanoparticle-Based Drug-Delivery Systems as Alternatives to Lipid Nanoparticles. 

Development

Exosomes, polymeric nanoparticles, and DNA nanostructures offer many potential advantages.

Organic Nanoparticle-Based Drug-Delivery Systems as Alternatives to Lipid Nanoparticles

The forward movement of the bio/pharmaceutical industry is driven by fast-paced advancements in manufacturing technology innovations. As manufacturing technology advances, so does the shift to continuous manufacturing (CM), a process that enables real-time monitoring, improved scalability, and enhanced quality control. As the industry increasingly adopts CM, it is undergoing a transformative shift.

In the current environment, one of the most significant applications of CM is in the production of RNA-based therapeutics, including messenger RNA (mRNA), self-amplifying RNA (saRNA), and circular RNA. In an interview with Aaron Cowley, chief scientific officer at ReciBioPharm (1), Cowley noted how industry leaders have spearheaded the development of CM platforms for RNA manufacturing with funding from FDA. These CM platforms hold the promise of significantly increasing production efficiency while maintaining rigorous quality standards.

In particular, the COVID-19 pandemic sharply highlighted the necessity of having rapid and scalable RNA manufacturing to meet global vaccine demand at the time. Traditional batch manufacturing poses bottlenecks that hinder timely drug availability. In comparison, CM integrates all unit operations into a seamless and continuous process and allows for real-time release and significant reduction in production timelines (2).

One of the key advantages of CM in RNA therapeutics is its ability to maintain small-scale yet high-throughput production. And, unlike monoclonal antibodies or conventional biologics that require thousands of liters in bioreactors, RNA production runs at much smaller scales—typically a few hundred milliliters to several liters per batch (3). CM becomes an ideal approach to tackling production of RNA-based products because it facilitates rapid adaptation and scale-up while at the same time minimizing waste and inefficiencies.

A significant innovation in CM for RNA therapeutics is the integration of in-vitro transcription (IVT) into a continuous process. Traditionally, IVT reactions are performed in batch mode, in which RNA synthesis is followed by downstream purification and formulation. But the continuous integration of IVT with purification and fill/finish operations allows for real-time monitoring and control, which leads to enhanced product consistency and yield (4).

“Being able to have eyes on the process and the product as it goes along, the full train of manufacturing, and be able to release that real time—is the overall goal that we are after,” said Cowley in the interview (1), explaining that if another pandemic comes along there won’t be a bottleneck in manufacturing, and that an RNA-based vaccine, for example, will be available and the manufacturing process will still be able to produce extra material.

On the small-molecule side, there is a trend toward higher potency and smaller dosing of APIs as, for the past 20 years, development and innovation in the pharma industry have focused on patient safety, meaning product quality, while also addressing cost efficiency and promoting greater sustainability, says Guia Bertuzzi, product manager of processing equipment for oral solid dosage (OSD) at IMA Active, the specialized division of the Italian company IMA Group.

“Modernizing the pharmaceutical industry requires both a more robust drug formulation design and better control of the production process, ensuring the highest quality and availability of the drug throughout its entire life cycle,” Bertuzzi states, adding that, “This concept strongly aligns with the adoption of the quality-by-design (QbD) approach, which prioritizes quality in drug development, as recommended by regulatory authorities. Furthermore, it paves the way for CM and other emerging technologies.”

Bertuzzi points to how CM fully supports the growing trend toward low-dose OSD forms and the increasing need for process containment and accuracy in quality control. “By definition, CM systems are designed for high-containment processes: they are typically compact, closed systems with a smaller process surface compared to batch manufacturing systems of equivalent productivity,” she explains. “Additionally, CM enables the integration of different production technologies in series, allowing for an uninterrupted material flow, from raw materials to the final pharmaceutical form, within a closed system that eliminates the need for product transfers between equipment, thereby minimizing the risk of product leakage.”

Because the CM process is continuously monitored in real-time with advanced instrumentation and an advanced control philosophy (i.e., process analytical technology [PAT]), the critical quality attributes (CQAs) of the product is also instantly monitored, allowing for increased sampling frequency without requiring physical sample collection, Bertuzzi states.

Modular and flexible manufacturing systems

The flexibility of CM, meanwhile, allows for modular process design, which enables manufacturers to switch between different modalities without major overhaul of infrastructure. The ability to switch between modalities is particularly important in RNA manufacturing as RNA therapeutics expand beyond vaccines to include gene therapies, cancer immunotherapies, and rare disease treatments. Having the ability to modify purification steps—such as adjusting the number of chromatography columns (based on impurity profiles)—will ensure that different RNA therapeutics can be produced efficiently and on a single platform (5).

However, despite the advantages that CM has demonstrated so far, the transition from traditional manufacturing to fully CM processes will continue to present challenges. Small and medium-sized enterprises (SMEs) will particularly face obstacles, including high initial investment costs, integration complexities, and the need for specialized expertise—factors that remain barriers to widespread adoption.

“Adopting CM requires a significant initial effort, including cultural and organizational changes within most pharmaceutical companies,” Bertuzzi says. “A company looking to implement CM must adequately prepare and structure itself. Beyond simply acquiring and integrating machinery in series, production and quality must be designed with a QbD approach, incorporating a higher level of automation and ensuring seamless integration between various technologies. This necessitates a strong orientation toward digitalization.”

Continuous manufacturing has gained increasing recognition by regulatory agencies such as FDA and the International Council for Harmonisation (ICH), which acknowledge CM’s potential and have issued guidelines (e.g., ICH Q13) to facilitate implementation (6).

“The drive toward CM will undoubtedly intensify due to the recent publication of regulatory guidelines (ICH Q13, FDA Q13, etc.) by major global authorities. Additionally, ongoing global challenges—such as pandemics, wars, and raw material shortages—further highlight the need for more efficient and resilient manufacturing processes,” Bertuzzi emphasizes.

Overcoming the challenges to full CM adoption will require strategic collaborations between biopharmaceutical companies, contract manufacturing organizations/contract development and manufacturing organizations, and technology providers. These collaborations will be crucial moving forward. In addition, standardization of CM technology platforms, especially those that incorporate modular automation, AI-driven process control, and cloud-based data analytics, will further enable CM adoption (7).

“From an equipment vendor’s perspective, we are actively driving the transition toward CM, particularly for SMEs, by providing process engineering support to facilitate adoption and implementation,” adds Bertuzzi.

1. Spivey, C. Biopharma’s Progress with Continuous Manufacturing in mRNA (BIO 2024). 

, Sept. 27, 2024.
2. Plumb, K. Continuous Processing in the Pharmaceutical Industry. 

 (A6), 730–738.
3. Kempf, H.; et al. RNA Manufacturing and Process Development: Current Trends and Future Outlook. 

 (10), 1168–1180.
4. Karmakar, S.; et al. Continuous Manufacturing of RNA Therapeutics: Opportunities and Challenges. 

, 107840.
4. Uhl, P.; et al. Flexible Manufacturing Strategies for RNA-Based Therapeutics. 

Guidance for Industry, ICH Q13 Continuous Manufacturing of Drug Substances and Drug Products

 (CDER, March 2023).
6. Konakovsky, S.; et al. Smart Manufacturing Approaches for Continuous Biopharmaceutical Production. 

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Vol. 49, No. 2
March 2025
Pages: 24–26

When referring to this article, please cite it as Mirasol, F. How Continuous Manufacturing is Advancing Bio/Pharma Production. 

Manufacturing

Continuous manufacturing offers advantages in both biotherapeutic and API manufacturing but still poses challenges.

How Continuous Manufacturing is Advancing Bio/Pharma Production

The successful build or retrofit of a pharmaceutical facility or lab area depends on competent design deliverables. The design team is challenged with designing a facility that meets client business and regulatory requirements but also incorporates all applicable codes and standards while understanding and mitigating site constraints. Speed to market for a product is often a critical project charter that emphasizes design schedule compression, adding another challenge for the design team. All of these challenges can lead to poor quality of design deliverables if a robust quality plan is not in place.

As the industry faces increased scrutiny to bring drugs to market quicker, and at the same time reduce costs, understanding the nuances of design quality becomes paramount. This commentary is intended to be a primer for companies that are just setting off down their own design path or working with outside consultants to build or retrofit their pharmaceutical facility.

Regardless of one’s level of expertise, however, it pays to be more fully versed on the ins and outs of design quality, and the implications of paying insufficient attention to this aspect throughout the project design phase life cycle.

It’s important to understand the difference between design quality and manufacturing quality. When people in the industry hear the word “quality,” they typically think of “manufacturing quality”—the process of ensuring the product meets validated quality acceptance criteria and is thus safe to release to the public.

Design quality refers to the process of producing technically correct design deliverables that will be used to build or modify an existing pharmaceutical facility. Technical correctness is more than just individual disciplines working on their scope. Accuracy of deliverables takes into account that all scope is shown correctly, follows appropriate codes and standards, meets client requirements, and is coordinated with other disciplines to provide a design that can be constructed and validated.

Drawings should be coordinated with specifications so there is no conflict or ambiguity. Deliverables between disciplines should look uniform by following well-defined project standards. If an engineering or architectural drawing is 100% technically correct but contains multiple spelling and graphical errors, the customer (owner/client, permitting Authority Having Jurisdiction [AHJ], or constructor) may question the accuracy of the deliverable because spelling, format, title block, and revision information errors reflect poor attention to detail.

The backbone of effective design quality is a robust quality management system (QMS). A QMS provides the framework by establishing standardized processes and procedures that the design team will follow. It encompasses the procedures for the entire firm, covering all aspects of design delivery, down to seemingly mundane elements like how drawings are set up and numbered. Adherence to the QMS aligns the team on policies and procedures to streamline operations, but also enhance traceability and accountability.In addition, the QMS establishes a means for continuous improvement of deliverables and procedures through lessons learned feedback.

The QMS framework should be developed in compliance with ISO 9001, which defines the requirements for a quality management system (1). ISO 9001 is the most recognized QMS standard and the only standard within the ISO 9000 series that organizations can be certified to. The International Council for Harmonisation (ICH) Q9 Quality Risk Management guideline is another valuable reference (2). It provides guidance on managing quality risk by providing tools and principles for controlling and communicating the risk.

It’s crucial to understand that while the QMS provides a strong quality framework and documents the processes required for project review stage gates, it’s not enough. Checking a box on a checklist does not always ensure technical quality is achieved.

Technical quality is achieved by orchestrating many different types of design reviews, facilitated by experienced peers, before deliverables are issued on a project. A second set of qualified eyes helps to identify items that might have been missed by someone who has been looking at the same documents for months. This collaborative effort also fosters accountability for design outcomes, for an overall better result that directly addresses facility requirements.

Sustaining design quality throughout the project with a rigorous design review process is paramount. The reviews should happen at a frequency defined in the project execution plan, and certainly before deliverables are issued to the customer. There are multiple different types of design reviews that can be performed on a project.

 All deliverables should undergo an intra-discipline technical check.This check should be performed by a peer from that discipline that is technically competent to review the deliverables. The discipline check should involve reviewing both drawings and specifications for intra-discipline coordination between documents and technical correctness. The checker should also verify quality attributes like format, spelling, revision information, notes, etc. to ensure they are presentable to the customer.

 The squad check is an inter-disciplinary review by all disciplines on a project. It provides the opportunity to review other discipline’s deliverables to ensure scope is coordinated between the team.

For example, a mechanical engineer should review electrical drawings to ensure all mechanical equipment is powered as-specified and safely. A reflected ceiling plan (RCP) should be checked by multiple disciplines such as electrical, mechanical, fire protection, and architecture to ensure there are no clashes between lights, diffusers, sprinkler heads, and ceiling system. The squad check also provides another opportunity to ensure spelling, format, and revision information is correct on the documents. If desired, the squad check exercise participants may include external team members such as the client, construction manager, and/or sub-contractors

 Clash detection is similar in many ways to a squad check, but it’s conducted in the project three-dimensional (3D) model. Coordination software looks for clashes between (new and existing) design elements such as equipment, piping, duct, lighting, walls, and building columns just to name a few. Clashes are not always evident on two-dimensional (2D) drawings, so using 3D visualization makes them easier to identify. The clashes are published to the design team for resolution.

A Building Information Modeling (BIM) coordinator will facilitate this exercise by running the clash detection software, logging the occurrences, and expediting clash resolution between disciplines. Although no design will ever be 100% clash free, the majority of clashes should be resolved before issue, and those that aren’t reconciled shall be documented for the field team to review and mitigate before constructing in the field.

 It’s important to review and mitigate risk throughout the project. Risk assessments can take on many different forms. Initially, the project should be reviewed by leadership to make sure it’s set up for success. The review should focus on scope, project risk, budget, schedule, and execution strategy.

A risk register is another useful tool to help mitigate risk. The risk register is used to document risks identified by the team along with the resolution after discussion with the client. Late project changes are another source of possible risk and can have a cascading effect on multiple disciplines on a project.

For example, if a process change requires ethanol, the project team needs to reevaluate codes and standards to confirm if design changes are warranted. A room may require fire rated walls and a specialized fire protection system where they may not have been required (or budgeted for) previously. This type of risk could be mitigated by conducting a proper third-party peer review to provide contingency guidance to the design team. It’s vital to evaluate and mitigate risk throughout the design development to set the project up for success.

It practically goes without saying, but neglecting design quality can result in dire consequences. The most alarming outcomes include heightened construction and operational safety risk, or even outright project suspension or cancellation impacting availability of the medicines that patients are depending on.

Beyond human impact, however, the financial repercussions of poor design quality can be severe. For design firms, insufficient attention to design quality upfront may affect the bottom-line profit—or worse yet, no profit at all if substantial corrections or changes need to be made to the design after construction begins.

Poor design quality can even expose companies to regulatory actions and lawsuits. This concern cannot be overstated. If a design leads to some type of catastrophe event such as a fire, loss of life, or product recall, the company could be subject to large fines or even lose their license to practice in a particular state.

In this regard, design quality just makes good business sense for companies providing architectural and engineering services to the pharmaceutical industry. A tarnished business reputation affects client trust and loyalty, which obviously makes it difficult to attract repeat clients. In an industry where a trustworthy and honest reputation is essential, the fallout from poor design quality can be catastrophic.

So, for companies that may be embarking on a design project for the first time, what are some fundamental takeaways?

As said at the outset, design quality is inherently different from manufacturing quality. Design quality focuses on ensuring the design team provides quality deliverables that are technically correct, follow all applicable codes and standards, are well coordinated between disciplines, and can be constructed and validated.

Quality must start at the project kick-off by establishing a well-defined quality plan.The QMS provides the framework that defines the processes and procedures for achieving the design objectives and helping to shape the project quality plan. Relying on procedures and checklists alone will not guarantee quality deliverables. The design reviews must be executed by technically competent peers (or subject matter experts) to ensure the accuracy of the design.

When starting a project, one must fully understand the user (customer) requirements and project design charter. The scope of the project must be articulated to design and construction partners to ensure the project team ultimately delivers an optimal facility.

When retrofitting an operating facility, all existing drawings, current manufacturing conditions, and new facility requirements should be shared with the design team very early in the project to plan for minimal production capacity interruption. An early and comprehensive foundation of scope understanding enables an efficient and meticulously detailed project with an accelerated delivery.

Design quality is not merely a regulatory checkbox; it is a foundational element of successful pharmaceutical manufacturing design. By prioritizing a rigorous approach to design quality, companies can mitigate risks, enhance employee safety, and foster a culture of accountability and excellence.

The stakes are high, and the importance of design quality cannot be overstated. As regulatory frameworks become more stringent and the industry evolves, a commitment to design quality will not only protect lives but also safeguard the future of pharmaceutical companies.

ISO. 9001:2015 - Quality Management Systems (ISO, 2021).

ICH. ICH Q9(R1) Quality Risk Management (ICH, 2023).

Aimee Penko is an engineering execution manager for Arcadis.

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Vol. 49, No. 2
March 2023
Pages: 28-30

When referring to this article, please cite it as Penko, A. Design Quality in Pharmaceutical Design: A Primer for Facility Executives. 

Quality

Being fully versed on the ins and outs of design quality can improve the project design phase life cycle.  

Design Quality in Pharmaceutical Design: A Primer for Facility Executives

signed a six-year, $1.4 billion contract manufacturing agreement

 with an as-yet undisclosed European pharmaceutical company, with production to take place at Samsung’s manufacturing site in Songdo, South Korea (1). Simultaneously, at the J.P. Morgan Healthcare Conference held in San Francisco, the company announced plans to complete construction of its fifth biomanufacturing plant, housed on a new campus—both scheduled to open in April 2025—and said it was considering construction of a sixth plant in response to growing market demands (2).

Even with its newly minted pharma partnership in hand, Samsung said the fifth plant would raise its global biomanufacturing capacity by 180,000 L to a total of 784,000 L, and the sixth plant would push that figure to 964,000 L. Such is the crunch that companies are feeling early in 2025 when it comes to capacity concerns and drug shortages these companies are trying to quickly and efficiently address.

John McQuaid, president and managing director of Almac Pharma Services, summarized just a few of those concerns 

“There's never been a larger number of molecules in clinical development, and we're certainly seeing that increasing demand,” McQuaid said in the interview (3). “We've got demand in areas such as [highly] potent [APIs], [and] age-appropriate formulations, such as pediatrics. We've got poorly soluble compounds, and the need for technologies to address that. And then we've got personalized medicines, such as, … cell and gene therapies, which drive particular needs in areas such as fill/finish and cold chain requirements.”

McQuaid added that the rise of glucagon-like peptide-1 (GLP-1) drugs are especially driving demand and, accordingly, stress about the supply chain.

As explained by Kevin Li, MBA, chief marketing officer at BioDuro-Sundia, 

 outsourcing strategy can take one of two paths: a “traditional” approach in which a bio/pharmaceutical company splits up its program and partners with one or more contract development and manufacturing organizations (CDMOs) and a separate contract research organization (CRO), or an integrated model—which can be looked at as either horizontal, with a partner providing services from discovery to development and commercial manufacturing, or vertical, integrating medicinal chemistry, biology, and drug metabolism and pharmacokinetics starting with the discovery phase into development (4).

“One side can handle both drug substance and drug product, and one side can handle the pre-formulation, formulation development, until commercial manufacturing, everything in one side,” Li told 

®. “It's very difficult and time-consuming to manage multiple vendors, and if you do integrate the program with one vendor ... that's much easier, simpler to manage the process to avoid any potential interruptions.”

, which was fully released at CPHI Milan, suggested that 

trends may shift dramatically by the beginning of 2028

 (5). The report said contract manufacturing organizations (CMOs) and hybrid companies, which have their own pipelines and contract services for using spare capacity, will grow to hold 54% of global biologics capacity within the next three years beginning with 2025. Capacity for new clinical products entering development, according to the report, may not be easily accessible in the United States—despite capacity being available—and Europe and Asia may account for up to 75% of all CMO resources available by 2028.

“We see many more biotechs and early-stage companies now attending [CPHI Europe] to find suitable capacity—particularly for small production runs where they are more likely to partner with one of the hundreds of smaller CDMO partners. Helping find these ‘perfect fits’ is vital,” said Tara Dougal, Brand & Content director—Pharma, Informa, in a press release announcing the CPHI report (5).

The following is a brief recap of company activity announced in the fourth quarter of 2024 that illustrates some strategic responses to capacity shortage concerns both internally and between partner organizations:

In November 2024, Ascend Advanced Therapies 

announced a partnership with EW Healthcare Partners

 with the intention of expanding capabilities and invest in infrastructure in the US, as a condition of which EW Healthcare’s Advanced BioScience Laboratories (ABL), a biotherapy, oncolytic, and viral vector CDMO in Rockville, Md., became part of Ascend (6). ABL’s facilities provide good manufacturing practice capacity for adeno-associated virus production, and Ascend’s fill/finish capacity in the US is also being expanded.

Also in November 2024, SEKISUI Diagnostics, headquartered in Burlington, Mass., 

completed a £15.7 million (US$20.7 million) expansion of current good manufacturing practice capacity

 at the Maidstone, UK site of its microbial CDMO, BioProduction by SEKISUI (7). “We look forward to working with biopharma companies seeking an experienced partner at a time when demand is outstripping manufacturing capacity,” Robert Schruender, president and CEO of SEKISUI Diagnostics, said in a press release at the time.

Finally, in December 2024, Israel-based biopharmaceutical company Scinai Immunotherapeutics, which develops inflammation and immunology biological products, 

announced the establishment of a US-based subsidiary,

 located in Delaware, for its CDMO services, operating under the same name as its Scinai Bioservices business unit (8). At the same time, Scinai signed its first contract with a US customer, Serpin Pharma of Manassas, Va., to support their clinical manufacturing.

What drugs may be in highest demand by 2028 or 2030 will ultimately drive the strategy of how bio/pharmaceutical companies seek and select outsourcing partners, but for 2025, easing the strain on the supply chain is the foremost priority.

1. Samsung Biologics. Samsung Biologics Signs Manufacturing Deal with Europe-Based Pharma. Fact Sheet. Jan. 13, 2025.
2. Samsung Biologics. Samsung Biologics Presents Business Updates at 2025 J.P. Morgan Healthcare Conference. Press Release. Jan. 15, 2025.
3. Thomas, F. 

CPHI Milan 2024: Pharma Industry Growth and Investment.

CPHI Milan 2024: Highlighting the Benefits of Integrated Services

CMOs and Hybrid Companies Predicted to Hold 54% of Biologics Capacity in 2028, According to CPHI Annual Survey

, Oct. 8, 2024.
6. Ascend. Ascend Advanced Therapies Partners with EW Healthcare Partners to Expand United States Capacity and Capabilities. Press Release. Nov. 12, 2024.
7. SEKISUI Diagnostics. SEKISUI Completes £15.7 Million Expansion in cGMP Biopharma CDMO Capacity. Press Release. Nov. 14, 2024.
8. Scinai Immunotherapeutics. Scinai Immunotherapeutics Establishes US Subsidiary for CDMO Business Unit, Scinai Bioservices Inc. Press Release. Dec. 16, 2024.

When referring to this article, please cite it as Lavery, P. Adopting Flexible Strategies to Combat Capacity Shortages. 

More and more contract manufacturers have been looking not at what the state of the supply chain is right now, but what it may be in the next three to five years.

Adopting Flexible Strategies to Combat Capacity Shortages

On 30 Jan. 2025, the European Commission (EC) launched a new Biotech and Biomanufacturing Hub to help European Union (EU) businesses, particularly small and medium enterprises (SMEs), to access support, expand, and grow (1).

The Hub offers access to EU funding for research and development (R&D), business development tools to market products on a global scale, regulatory guidance on product approval, and compliance and support for intellectual property rights to protect innovative products (1).

The Hub is accessible on the EC’s Your Europe portal to EU nationals, nationals of European Arenas Association (EAA) countries, family members of EU/EEA nationals, non-EU nationals that enjoy EU rights, and businesses with headquarters in a EU country (2). A task force of advisors will guide the continuous development of the portal (3).

In June 2023, the EC proposed a regulation to establish a new platform for Strategic Technologies for Europe Platform (STEP) (4). STEP aims to support the development and manufacturing of critical technologies and to address any shortage of labour and skills. Several proposals were outlined in STEP to boost biotechnology and biomanufacturing in the EU, these are summarized in 

On 1 March 2024, the STEP Regulation (Regulation (EU) 2024/795) came into force (6). The STEP platform has access to €160 billion in funds to invest in strategic projects that develop or manufacture critical technologies namely:

biotechnologies—molecular biotechnology, pharmaceuticals, crop biotechnology.

clean and resource-efficient technologies—capture and storage technologies, and heat pumps.

digital technologies and deep technology innovation—artificial intelligence (AI), advanced connectivity, and quantum technologies (4).

STEP stakeholders include governments, regulatory bodies, industry leaders, research institutions, and the public. The STEP Task Force coordinates and cooperates with stakeholders to address funding challenges and identify new opportunities.

The Biotech and Biomanufacturing Hub will help European companies access funding, navigate regulations, and speed up market access.

Pharmaceutical Technology, March 2025

Accelerating Adoption of Smart Tools to Advance Manufacturing

Full Tolerance Coverage Method for Assessing Uniformity of Dosage Units with Large Sample Sizes

Organic Nanoparticle-Based Drug-Delivery Systems as Alternatives to Lipid Nanoparticles

How Continuous Manufacturing is Advancing Bio/Pharma Production

Design Quality in Pharmaceutical Design: A Primer for Facility Executives

Adopting Flexible Strategies to Combat Capacity Shortages

Launching the New Biotech and Biomanufacturing Hub

Developments in Aseptic Processing

Pushing Tech Boundaries