Feliza Mirasol is the science editor for 

Feliza Mirasol

Industry innovation in bio/pharmaceutical 

, and patient-focused technologies took center stage as winners of the 

 were announced at a ceremony held during 

. With hundreds of entries submitted across 13 categories, scientific and technological achievements that are shaping the future of global healthcare were especially highlighted (1).

The event drew bio/pharma professionals from around the world and recognized companies, technologies, and individuals driving impactful progress in areas such as sustainability, 

“This year, we received an incredible number of outstanding award submissions, and it was tough to choose winners for each category,” said 

, events director, Pharma Portfolio, Informa Markets, in an Oct. 29, 2025 company press release (1). “Last night was an opportunity to celebrate excellence across our industry, and the winners and those shortlisted for an award should be so proud of their achievements.”

What advances in APIs, continuous manufacturing, and device innovation were recognized?

Winners represented a broad mix of technology platforms and development capabilities. In API Development & Innovation, 

 was awarded for its TAPS: TAG Assisted Peptide Synthesis, reflecting continued momentum in peptide-based medicines. Synthetic DNA developer 

 earned recognition for "Custom, cell-free, synthetic DNA" within the Accelerating Innovation category.

Continuous processing remained a high-visibility theme as 

 received the Manufacturing Excellence award for EnzeneX—Fully-connected continuous manufacturing, which reflects a wider industry movement toward automated bioprocessing for agility and efficiency (2).

In the Drug Delivery and Device Innovation category, 

 was honored for its YpsoLoop pre-filled autoinjector. This technology innovation reflects the rising demand for self-administration platforms that improve accessibility for biologics (3).

 for its Integrated End-to-End Supply Chain Platform supporting advanced therapies

 for “Producing QS-21, the Gold Standard Vaccine Adjuvant.”

, underscoring executive leadership in growing biologics infrastructure, while the Future Leader award was granted to 

 for contributions to advanced manufacturing skill development.

, in recognition of her impact in expanding workforce representation across the bio/pharma field. In addition, industry workforce inclusion was further highlighted with 

’ win of the At the Heart of Pharma category for its “Talent without Barriers” initiative.

Finally, recognition of entrepreneurial contributions came through the Start-Up Initiative award, which was granted to 

Meanwhile, the next CPHI Pharma Awards cycle opens early next year, with submissions opening in February 2026. The awards will continue to showcase advancements across the global bio/pharmaceutical ecosystem (1).

CPHI Frankfurt runs Oct. 28–30, 2025. To view more of our conference coverage, 

1. Informa Markets. CPHI Pharma Awards 2025 Winners Announced. Press Release. Oct. 29, 2025.
2. Shajahan, M. A. 

Bioprocess Automation with Robotics: Streamlining Microbiology for Biotech Industry

Asia Pacific Journal of Energy and Environment

 (2/2022), 61–70.
3. Antalfy, A.; Berman, K.; Everitt, C.; et al. The Adherence and Outcomes Benefits of Using a Connected, Reusable Auto-Injector for Self-Injecting Biologics: A Narrative Review. 

Articles

The CPHI Pharma Awards 2025 celebrated significant advancements in bio/pharmaceutical development, manufacturing, and patient-focused technologies. The event highlighted achievements in sustainability, drug delivery, and supply chain resilience, with winners like Corden Pharma for peptide synthesis and NunaBio for synthetic DNA. Enzene's continuous manufacturing and Ypsomed's autoinjector were also recognized. Leadership awards went to Lars Petersen and Adriana Kiędzierska-Mencfeld, while CNX Therapeutics and Green Elephant Biotech were acknowledged for workforce inclusion and entrepreneurial innovation, respectively. The next awards cycle begins in February 2026.

CPHI 2025 awards spotlight progress in pharmaceutical manufacturing, API development, automated processing, and sustainability driving future production.

CPHI 2025 Awards Spotlight Breakthroughs in Pharmaceutical Manufacturing and API Development

React4Life’s Silvia Scaglione emphasizes how organ-on-chip tech and AI are reshaping drug testing, personalized treatment, and the future of bio/pharma innovation. 

How Organ-on-Chip Tech and AI Are Transforming Drug Development

, Silvia Scaglione, PhD, director of research at the National Research Council in Italy and founder of React4Life, an Italy-based biotech company specializing in organ-on-chip technology, spoke about the advancement of organ-on-chip platforms in 

. Her insights reveal a transformational period in translational research and drug development, with the potential to reshape preclinical testing and personalized medicine globally.

In particular, organ-on-chip technology (such as React4Life’s platform) facilitates growth and analysis of patient-derived tissue samples. This capability enables researchers to potentially drastically reduce time, cost, and failure rates typically associated with traditional preclinical studies, Dr. Scaglione emphasizes.

How is organ-on-chip technology revolutionizing drug testing and personalized medicine?

“For the first time, it’s possible to reduce the time and cost typically spent during the preclinical stage, and, moreover, we can also reduce the failure in [the] clinical stage due to the wrong experimental setup,” Dr. Scaglione notes.

An important aspect of organ-on-chip technology is the ability to connect multiple organ models—such as gut, brain, and skin—which allows researchers tomimick complex human physiological interactions. This multi-organ connectivity enables researchers to assess drug efficacy holistically, observing not just local but also systemic impacts, Dr. Scaglione emphasizes.

The integration of the microbiome within the organ-on-chip system further enhances disease modeling, offering critical insights into how gut health influences drug responses, especially in cancer therapies, she explains.

Dr. Scaglione also champions the role of AI and in-silico methods in streamlining drug candidate selection. By combining machine learning with organ-on-chip platforms, companies like React4Life aim to set new benchmarks for accuracy and efficiency in drug discovery.

Dr. Scaglione spoke at CPHI Frankfurt on Oct. 28 in the session “

Lightning Talk: Innovating the Future of Biologics R&D

.” CPHI Frankfurt runs Oct. 28–30, 2025.

Silvia Scaglione, PhD, Director of Research, CNR, and Chief Scientist, React4Life

Since 2010, Dr. Scaglione has been a permanent researcher at the National Council of Research in Italy, becoming a senior researcher in 2021 and leading the tissue engineering team. In 2017, she founded React4Life, an Italian biotech company that develops organ-on-chip technologies to accelerate translational research and improve the reliability of drug testing. React4Life has won several international projects and awards, including the EU Innovation Radar Award for Best Health Technology and the CPHI Award in 2023. Dr. Scaglione is also an ambassador for the European Innovation Council. She received her PhD in bioengineering from the University of Genoa (Italy) and was a visiting scientist at the University Hospital of Basel (Switzerland).

Editor's note: This transcript is a direct, unedited rendering of the original audio/video content. It may contain errors, informallanguage, or omissions as spoken in the original recording.

 I'm Silvia Scaglione. I'm a director of research at the National Research Council in Italy, and I also founder and chief scientist of React for Life, which is an Italian deep tech biotech company which developed and commercialized an organon a chip platform for translational research and drug testing.

 What impact does the industry see from using dynamic human tissue systems in preclinical testing as alternatives to traditional in vivo methods?

 The impact is really huge and amazing, because the use of dynamic human organ energy platform are really changing the use of and the adoption of alternative experimental model during pre clinical stage. Indeed, for the first time, it's possible to reduce the time and cost typically spent during the pre clinical stage, and moreover, we can also reduce the failure in clinical stage due to the wrong experimental setup. Moreover, we have also introduced something related to the personalized approach, because we can really host and grow personalized the patient derived tissue samples and testing different therapies for selecting the best therapy for that patient, for that disease. Soit's really a revolutionary impact.

 How crucial is the ability of advanced models to enable precise controlover factors such as barrier function and mucus production and increasing the reliability and predictability of drug permeation data?

 It's really important to have the possibility to control and quantify the readout during the use and adoption of organism platform, because just an example, when you use a gut on a chip platform, you have the possibility to measure the barrier function of the gut, and at the end, you can discriminate if you are working with a healthy tissue model versus an IBD or clone disease intestinal models, so the possibility to properly control measure and quantify the readout, enable to control the experiment, to decouple different behaviors and to discriminate healthy versus pathological diseases, And of course, related to these there is a possibility to properly quantify the efficacy of new treatments by analyzing the effect of this therapy on the tissue

 Now, from an industry perspective, how does the integration of tissue models into multi organ systems, such as simulating the gut–skin axis, reshape the approach to testing efficacy for oral treatments?

 It is really important to have the possibility to work with multi organ connections. Connection. That is what is possible using how our vivo, proprietary organ energy platform, because we can fluidically connect multiple organs like that versus skin, but also gut versus brain or gut cancer. And this is amazing, because for the first time, you can control and observe the effect of the therapy, not only on the localorgan, but using a holistic perspective, so analyzing, for instance, a therapy orally administered, but also evaluating its effect on a target tissue, it which might be far from the gut. And in this case, we can introduce a systemic approach, which is revolutionary for increasing the reliability of the readout.

 Beyond accelerating general drug screening. What are the primary ways that validated tissue platforms are currently supporting innovation in the development of microbiome-based therapies?

 Well, the microbiome modulates a lot of biological and pathological things in our in our body, so the possibility to introduce microbiome within the organon chip enable to unlock new testing and new complex disease modeling. Just an example. We have co culture gut microbiota into the gut on a chip platform, which was critically connected to the cancer model, and we have successfully demonstrated what it is observed in clinics, that is the fact that the dysbiosis in the gut might drastically reduce the efficacy of the anti cancer drug treatment, and this is due To the cross talk between microbial with local and systemic organs. I just

 How is the biologic sector reimagining supply chains to protect against rising tariffs, geopoliticalshocks, and global disruptions?

 This is really a critical point, because we have understanding that the geopolitical situation might also drastically affect industrial decision. What we have done in reactor Life is to internalize completely the supply chain. Soat the moment, the product of React for Life is fully made in Italy. So we have decided to select our supplier among the supplier of the Italy ecosystem, in order tofacilitate a more robust and stable relationship. I don't know if it's the same choice of pharma company, but for sure, this is what we have done.

 And what role do AI and digital technologies play in accelerating drug discovery and improving manufacturing efficiency, and what are some unresolved barriers to full adoption of these technologies?

 AI definitely is a key point, and in some cases, I will say alsoit's a buzz word used just because it's important and mandatory to be used in the drug testing. What, what is my experience is that it's really important to adopt also in silico approaches like machine learning AI based approaches, but also in the past, before the AI massive adoption drug testing has adopted in silico solutions during the drug testing to accelerate and improve the reliability of the selection of the niche and lead candidates.

Videos

SK pharmteco, a contract development and manufacturing organization (CDMO), announced on Oct. 23, 2025 that it has made a $6.1 million investment in its Rancho Cordova, Calif., facility to expand its capabilities in solid-phase peptide synthesis (SPPS) and purification. The move establishes new laboratory and current good manufacturing practice (CGMP) kilo-scale operations and reflects the company’s broader effort to reinforce United States domestic peptide production capacity (1).

For developers and manufacturers of peptide-based drugs, this investment addresses a persistent challenge in the supply chain—the limited availability of reliable, large-scale peptide production and purification within the US. Peptide-based drugs are a class of therapeutics increasingly central to targeted and precision medicine.

“The investment in our California facility represents a key milestone in our strategic growth and demonstrates an unwavering dedication to the domestic biopharma sector,” said Joerg Ahlgrimm, CEO, SK pharmteco, in the press release (1). “Peptides are a vital and rapidly advancing therapeutic category. This project highlights our ongoing commitment to furthering their development and manufacturing.”

Why are peptides a bottleneck in drug development?

While SPPS is well established at the laboratory level, scaling up remains a complex and resource-intensive process. The main bottleneck often arises during purification, when separating target molecules from impurities becomes unpredictable at higher volumes. This variability can delay timelines for clinical and commercial supply, making high-throughput purification a critical technical capability for CDMOs (2).

SK pharmteco’s investment specifically targets this bottleneck by leveraging its proprietary chromatography expertise, which is an area where the company has established a reputation for innovation. By integrating development, synthesis, and purification under one roof, the expansion enables a seamless path from early process development to large-scale production (1).

What does this investment mean for the biopharmaceutical supply chain?

The expanded California site not only increases US-based manufacturing resilience but also complements SK pharmteco’s global manufacturing network, including a $260 million small-molecule and peptide production facility under construction in South Korea (3). This dual-site strategy enhances both regional and global supply reliability for APIs, an area in which manufacturing concentration abroad has long been a strategic vulnerability for the biopharmaceutical industry (4).

“We are expanding our capacity to meet the increasing demand for high-quality, secure US manufacturing, with this investment and others to come,” Ahlgrimm said in the release. “While many companies are now committing to expanding capacity in the US, CDMOs like SK pharmteco remain a vital part of the supply chain, both now and in the future. Our stronger network accelerates the journey from discovery to commercial production, boosting the resilience of domestic manufacturing to deliver essential medicines more quickly to patients.”

The new lab in the California site is slated to begin operations in January 2026, with the kilo-scale facility following in the second half of that year. For biopharmaceutical developers seeking dependable US-based partners, this initiative signals an important evolution in how complex peptides are developed, purified, and brought to market—an advancement that may reshape the domestic manufacturing landscape moving forward (1).

, being held Oct. 28–30, 2025. Attendees can visit the company at stand 6.1C6 in the Contract Manufacturing and Services zone.

SK pharmteco Boosts Domestic Peptide Scale-Up with Investment in California Facility

. Press Release. Oct. 23. 2025.
2. Wang, L.; Wang, N.; Zhang, W.; et al. Therapeutic Peptides: Current Applications and Future Directions. 

SK pharmteco Invests $260 Million to Expand Global Small Molecule and Peptide Production

. Press Release. Sept. 30, 2024.
4. Javarayee, P.; Meylor, J.; Shahrukh, S.; et al. US Generic Antiseizure Medication Supply Chain: Observations from Analysis of US Government Databases. 

SK pharmteco has invested $6.1 million in its Rancho Cordova, California facility to enhance solid-phase peptide synthesis and purification capabilities. This expansion aims to address the limited large-scale peptide production in the US, crucial for peptide-based drugs in precision medicine. The investment targets purification bottlenecks using proprietary chromatography expertise, integrating development and production processes. This move strengthens US manufacturing resilience and complements SK pharmteco's global network, including a new facility in South Korea, enhancing API supply reliability and accelerating drug development timelines.

SK pharmteco boosts US peptide synthesis and purification capabilities, advancing reliable large-scale manufacturing for biopharma innovation.

SK pharmteco Strengthens Domestic API Supply Chain with New Peptide Facility

Although such biologics as monoclonal antibodies (mAbs), recombinant proteins, and nucleic acid-based therapies have revolutionized disease treatment across therapeutic domains, their utility remains constrained by a near-exclusive reliance on parenteral administration. Intravenous and subcutaneous administrations pose challenges for patient compliance, safety, and accessibility. Because of the limitations on parenteral routes of administration, the development of non-parenteral alternatives, such as oral, inhaled, transdermal, and intranasal formats, represents both a clinical imperative and a formidable scientific challenge. 

Challenges, Innovations, and Future Outlook of Biologics Formulations

An evaluation of the molecular and technical barriers to non-parenteral biologics delivery, as well as reviews of state-of-the-art advancements in formulation technologies and an assessment of current collaborative progress across the biopharmaceutical ecosystem, can shine light on where the biopharma industry stands today in terms of non-parental formulation market readiness. The latest developments led by contract manufacturers, biotechnology innovators, and academic partners will highlight the progress and outlook for emerging delivery systems poised to redefine patient-centric biologics administration (1–3).

How is the biologics delivery landscape evolving?

Despite the promise of mAbs, recombinant proteins, and nucleic acid-based therapies, more than 95% of biologics are still administered via injection or infusion. This dominant reliance on parenteral administration stems from the complex physiochemical properties of biologics, which are of large molecular weights and have structural fragility, as well as susceptibility to enzymatic degradation. These characteristics preclude simple oral dosing. However, reliance on repeated injectable dosing has been shown to result in reduced patient adherence, fear of needles, and added burden on healthcare systems (1–3).

The industry has thus turned its attention to alternative, less-invasive delivery modalities. Oral and inhaled biologics are attracting intensified R&D investment due to their broad patient acceptance, potential for home administration, and alignment with precision medicine initiatives. Market forecasts underscore this momentum. For instance, the oral biologics market is projected to expand at a compound annual growth rate (CAGR) of 35% between 2023 and 2028, while the inhalation contract development and manufacturing organization (CDMO) sector is expected to grow from $1.94 billion in 2023 to $2.7 billion by 2028, a 7.1% CAGR. In specific disease areas, such as asthma, biologic therapies are projected to reach $19.2 billion by 2031, signaling significant demand for innovations in pulmonary delivery (4,5).

What challenges present hurdles to non-parenteral biologics delivery?

Biologics are inherently more complex than small-molecule drugs owing to their large molecular weights, higher structural complexity, and sensitivity to pH, temperature, and proteolytic enzymes. Furthermore, the cost of biologics manufacturing places extreme importance on bioavailability, where even marginal losses during administration render a dosage form economically unviable (1,2,5,6).

Oral delivery of biologics faces route-specific obstacles, such as rapid degradation via enzymes in gastric and intestinal environments; impermeable epithelial and mucosal barriers, which prevent molecules larger than a few hundred Daltons (Da) from passing through (antibodies are typically >150 kDa); reduction of systemic bioavailability upon first-pass metabolism; and intestinal variability across patient populations, which further complicates pharmacokinetics (3). Clinical successes for oral biologics have been scarce, with oral peptide products (e.g., oral semaglutide) demonstrating feasibility but not yet scalability for large proteins or antibodies (7–8).

Although inhalation delivery offers direct access to systemic circulation through pulmonary vasculature, this route of administration suffers from technical and clinical constraints. Historical failures of inhaled insulins (e.g., Pfizer’s Exubera) have highlighted flaws in device ergonomics, interpatient variability, and costs as major barriers to commercialization. In addition, biologics must be formulated to remain stable during aerosolization, storage, and pulmonary transport, which often presents a steep technical challenge (2,9).

Meanwhile, a transdermal delivery option is severely limited by the outermost layer of skin (stratum corneum), which blocks hydrophilic and high-molecular-weight compounds. Advanced approaches, such as microneedle arrays, iontophoresis, and microporation, show promise but are so far limited to peptides or low-dose biologics (10).

What cutting-edge formulation and delivery technologies are in the works?

Particle engineering and inhalation platforms.

 Lonza is advancing particle engineering strategies to modulate pharmacokinetics and bioavailability in spray-dried powders. Collaborations with Iconovo have yielded intranasal biologics targeting obesity, leveraging the ICOone Nasal device to optimize dose delivery (11). Similarly, Lonza’s collaboration with Ethris is aimed at applying spray-drying techniques to stabilize messenger RNA (mRNA)-based vaccines at room temperature, reducing cold chain dependency while maintaining mRNA integrity (12).

In addition, CrystecPharma, in partnership with Intertek, is leveraging its modified supercritical anti-solvent (mSAS) technology to precipitate biologics into stable dry particles. Their fast-track dry powder inhaler platform accelerates development from laboratory design to good manufacturing practice and offers a robust approach for inhaled protein and peptide therapies (13).

 Lonza is also pursuing smart capsules, designed for site-specific targeting within the gastrointestinal tract. These smart capsules employ mechanical and electronic components that enable release in the stomach or intestine. Bi-layer capsule technologies further allow compartmentalized release profiles tailored to molecule-specific pharmacology (14).

Meanwhile, Catalent Pharma Solutions is exploring lipid-based formulations (LBFs), building on established small-molecule solubilization methods to enhance macromolecular absorption. One promising line of research focuses on transiently modulating intestinal tight junctions to facilitate the uptake of high molecular weight biologics, a potentially transformative approach for oral mAbs (15–16).

US Specialty Formulations (USSF) has advanced QYNDR, a drinkable, protein-based oral/mucosal vaccine that demonstrated safety in Phase I COVID-19 clinical trials in 2023. Such approaches bypass the gastrointestinal degradation barrier by targeting mucosal tissue for immune activation, representing an alternative strategy for non-parenteral vaccination (17,18).

 Transdermal microneedle patches, jet injectors, and sonophoresis platforms are also under evaluation for delivering smaller biologics, such as peptide vaccines. While dose limitations restrict broader application, such technologies could complement inhaled and oral products in specific contexts, particularly for pediatric or resource-limited populations (1,10).

 The urgency of the COVID-19 pandemic catalyzed progress in non-parenteral biologics, particularly inhaled and intranasal vaccines. Self-administered inhalable or nebulized mRNA/lipid nanoparticle formulations targeting pulmonary diseases are anticipated in the near-term. These formats may be especially impactful for respiratory-targeted therapies, enabling localized lung delivery with systemic immune benefits (19).

 Despite substantial momentum, effective oral or inhaled mAbs remain elusive. Addressing dose limitations, ensuring molecular integrity through complex biological barriers, and establishing reproducible absorption profiles remain key barriers. Moreover, large-scale clinical validation and long-term safety data will be essential before such platforms achieve widespread commercialization (2,3,7,8).

 The diversity of biologics under development suggests that no single non-parenteral strategy will dominate. Instead, modalities will be tailored: oral delivery for chronic, systemic diseases; inhalation or intranasal delivery for respiratory or mucosal immunity; and transdermal approaches for lower-dose applications. The overarching driver will continue to be the pursuit of patient-centric care—convenient, non-invasive, and accessible therapeutics that reduce healthcare burdens while improving treatment adherence (1,2).

1. Mitragotri, S.; Burke, P. A.; Langer, R. Overcoming the Challenges in Administering Biopharmaceuticals: Formulation and Delivery Strategies. 


2. Chauhan, V. M.; Zhang, H.; Dalby, P. A.; Aylott, J. W. Advancements in the Co-Formulation of Biologic Therapeutics. 


3. Muralidhara,B. K.; Wong, M. Critical Considerations in the Formulation Development of Parenteral Biologic Drugs. 

Global Oral Biologics Market Size, Share, Trends & Growth Forecast Report by Drug Class, Disease Indication, Distribution Channel, and Region (North America, Europe, Asia-Pacific, Latin America, Middle East and Africa), Industry Analysis from 2025 to 2033

. Market Research Report. April 2025.
5. The Business Research Company. 

Inhalation CDMO Global Market Report 2025—by Product (Dry Powder Inhaler (DPIs), Metered Dose Inhaler (MDIs), Nebulizer, Soft Mist Inhaler), by Disease Indication (Asthma, Chronic Obstructive Pulmonary Disease (COPD), Pulmonary Arterial Hypertension, Acut

 Market Research Report. January 2025.
6. Synapse by Patsnap. 

What are the Common Challenges in Biologic Drug Development

. March 20, 2025.
7. Andersen, A.; Knop, F. K.; Vilsbøll, T. A Pharmacological and Clinical Overview of Oral Semaglutide for the Treatment of Type 2 Diabetes. 


8. Kalra, S.; Das, S.; Zargar, A. H. A Review of Oral Semaglutide Available Evidence: A New Era of Management of Diabetes with Peptide in a Pill Form. 

 
9. Cefalu, W. T. Concept, Strategies, and Feasibility of Noninvasive Insulin Delivery. 


10. Prausnitz, M. R.; Langer, R. Transdermal Drug Delivery. 

Iconovo and Lonza to Collaborate on the Formulation Development of an Intranasal Biologic

. Press Release. Jan. 13, 2025.
12. Ethris. 

Ethris and Lonza Collaborate to Develop Spray-Dried mRNA Vaccines for Respiratory Disease Prevention

. Press Release. Feb. 11, 2025.
13. Intertek. 

Intertek Partners with CrystecPharma to Advance Formulation Science and Accelerate Development Timelines for Dry Powder Inhaler Products

. Press Release. Dec. 11, 2024.
14. Lonza. 

Lonza Launches Tailored Offering for Smart Capsules Companies Developing Oral Delivery Solutions for Biologic Drugs

. Press Release. Dec. 3, 2024.
15. Mirasol, F. 

The Need for LBFs and Challenges in Oral Biologic Formulation (AAPS PharmSci 360)

Lipid-Based Delivery Systems—New Approaches for Macromolecule Oral Delivery, Abuse Deterrence & Bioavailability Enhancement

US Specialty Formulations Completes Phase I of Clinical Trials for the QYNDR Vaccine

. Press Release. Sept. 7, 2023.
18. Zhang, Z.; Hong, W.; Zhang Y.; et al. Mucosal Immunity and Vaccination Strategies: Current Insights and Future Perspectives. 

How Inhaled mRNA May Help Rare Disease Patients Breathe Easier

When referring to this article, please cite it as Mirasol, F. Challenges, Innovations, and Future Outlook of Biologics Formulations. 

Biologics, including monoclonal antibodies and nucleic acid-based therapies, face challenges due to their reliance on parenteral administration, impacting patient compliance and accessibility. The industry is exploring non-parenteral delivery methods like oral, inhaled, and transdermal formats, driven by patient-centric care and precision medicine. Despite technical hurdles, advancements in formulation technologies and collaborations are paving the way for innovative delivery systems. The market for oral and inhaled biologics is projected to grow significantly, although challenges in bioavailability and stability remain critical barriers to widespread adoption.

Non-parenteral alternatives for biologics remain a clinical imperative and a formidable challenge.

, being held Oct. 6–8 in Phoenix, Ariz., panelists indicated that the rapid scientific acceleration within the cell and gene therapy (CGT) sector that is yielding transformative clinical data across new cancer (e.g., glioblastoma, ovarian) and non-cancer indications is placing immense pressure on the current manufacturing infrastructure.

Industry leaders convened during the session titled “The New Standard for CGT Manufacturing: Flexibility and Scalability” on Oct. 6 to address this bottleneck, arguing that the industry must transition to a new paradigm—labeled CGT 2.0—that delivers both flexibility and scalability simultaneously (1).

, CEO and executive director of Ori Biotech, the panel stressed that the traditional trade-off between maintaining process flexibility for early-stage development and planning for large-scale commercial viability is no longer sustainable.

"The idea is to provide flexibility and scalability at the same time, and we're going to talk about how we do that; and that really is a hallmark of what I would call CGT 2.0," Foster said at the start of the panel discussion (1).

For the biopharmaceutical industry, success in CGTs can no longer be defined solely by clinical efficacy, the panel discussion revealed. 

, chief strategy officer and head of artificial intelligence (AI) at OmniaBio, emphasized the need for a "working backward" approach, in which the end state is defined by widespread patient access and affordability. This approach means that manufacturing must be viable not just in large academic medical centers (AMCs), such as California-based City of Hope or Children’s Hospital of Philadelphia (CHOP), but deliverable in community hospital settings.

"If you ask 90% of the people in this industry what their end state is, it's a clinically effective and safe product,” Harris said during the panel. “That is one of the pillars, but that is not the only pillar."

Meanwhile, neglecting chemistry, manufacturing, and controls (CMC) early on results in a non-viable product, emphasized 

, vice-president, Cell and Gene Therapy Operations, City of Hope. Ahsan confirmed that due diligence by potential partners is increasingly focused on manufacturing viability, making CMC a "dealbreaker" even when clinical data are promising. "The clinical data, or even the animal data, will bring [partners] to the table, but, more and more, their due diligence is super focused on the CMC, and that is turning into deal breakers," she stated.

What do platform processes and modular systems bring to the table?

To enable flexibility, AMCs, such as City of Hope, are leveraging platform processes—modular units that are already vetted and can support multiple investigational new drug (IND) applications rapidly. For example, City of Hope uses a few platforms to support 18 INDs, Ahsan pointed out.

, senior vice-president, Innovation Ventures, Children’s Hospital of Philadelphia (CHOP), also highlighted the notion that future flexibility requires defining modular and interoperable systems that are compatible with various cell types, delivery systems, and payloads, including stem cell work, chimeric antigen receptor T cells (CAR-T), and personalized gene editing therapies. "Over the past 10 years, it really has been … academic medical centers that have developed these processes initially," Wilton said.

What strategies can be used to reduce end-product variability?

A major hurdle for scaling CGT manufacturing is process variability. Even highly trained human operators invariably introduce variation that batch records cannot capture, noted 

, senior director, Allogeneic and Autologous Cell Therapy Development, Johnson & Johnson Innovative Medicine, in the panel. This human factor makes automation crucial for reproducibility and rapid scalability, Snowden pointed out.

Simple automation in manual processes is considered "low hanging fruit" for improving quality and reducing costs, Snowden commented. "[One will] see an extraordinary amount of variability because of the subtleties of the execution that can never be put into a batch record or training without them turning into a novel sized document," he explained.

Furthermore, the industry suffers from a significant data gap as it often fails to analyze or share the data collected. Harris explained that OmniaBio, in addressing this data gap, utilized a simple AI platform to analyze human labor and process steps in their operations and identified 27% cost savings in labor, underscoring the immediate financial impact of leveraging basic analytics. The ultimate goal is adaptive control, in which systems use machine learning to guide real-time manufacturing decisions, Harris stated.

What is the benefit of building a collaborative CGT ecosystem?

The panelists concluded that achieving CGT 2.0 requires a profound "mentality shift" from viewing development as a research endeavor to treating it as a commercialization program. Collaboration is paramount to eliminating time-consuming tech transfers, which can currently take 12 to 24 months, the panelists discussed.

AMCs, for instance, must partner with technology providers to offer a "sandbox" environment for rapid iteration and enhancement of new manufacturing platforms, ensuring they are suitable across all patient populations. The panelists agreed that industry players must come together and prioritize what benefits the overall field, rather than individual organizations, which entails promoting data sharing and interoperability. In this way, the entire CGT sector can move toward exponential growth and widespread patient access. The elimination of bottlenecks, identified early through principles such as Kaizen (2) or the Theory of Constraints (3), and optimizing the "last mile" logistics (product delivery to the patient) are also essential to driving down the persistently high cost of goods.

1. Cell and Gene Meeting on the Mesa. The New Standard for CGT Manufacturing: Flexibility and Scalability. Presentation at Cell and Gene Meeting on the Mesa, Oct. 6, 2025. 


2. Abuzied, Y. A Practical Guide to the Kaizen Approach as a Quality Improvement Tool. 

Theory of Constraints (TOC) of Dr. Eliyahu Goldratt

The rapid advancements in cell and gene therapy (CGT) are challenging existing manufacturing infrastructures, necessitating a shift to a new paradigm, CGT 2.0, which emphasizes flexibility and scalability. Success in CGT now requires not only clinical efficacy but also widespread patient access and affordability. The focus on chemistry, manufacturing, and controls (CMC) is crucial for product viability. Automation and data analytics are key to reducing variability and costs. Collaboration across the industry is essential to overcome bottlenecks and achieve exponential growth and patient access.

At the Cell and Gene Meeting on the Mesa, a panel discussion was held on advanced therapy production and how it demands modular platforms, automation, and data governance to drastically improve patient access and affordability.

The Importance of Building in Flexibility and Commercial Viability Early in the CGT Scaling Process

With the 31st annual BIO-Europe conference set to take place in Vienna, Austria, from Nov. 3–5, 2025, the event is anticipated to gather more than 5700 attendees from more than 3000 companies across the global biopharmaceutical industry. Produced by EBD Group, the conference has established itself as one of the largest forums for collaboration, licensing, and investment discussions in drug development and manufacturing, according to a company press release (1).

Partnering around the event has been underway since Sept. 22, 2025, and organizers expect more 30,000 one-to-one meetings, reflecting the growing demand for structured platforms that enable technology-driven collaborations.

For those in the biopharma industry, the scale of BIO-Europe illustrates how early partnerships have become critical to drug manufacturing and commercialization strategies. The event’s discussions will explore how companies can adapt development pipelines, improve clinical success rates, and secure the investment needed to advance new therapeutic modalities.

The Vienna program features a range of sessions designed to address current industry challenges and future directions. The opening plenary session, titled “

A symphony or a solo act? Europe’s role in biopharma’s future,

” will bring together IPSEN CEO David Loew and Ovid Therapeutics CEO and Chairman Jeremy Levin to debate whether Europe can maintain its competitive edge in healthcare innovation or risk ceding leadership to other global regions.

The financing environment for biopharma will be explored in “

From Roast to Billions: Biopharma Investment Landscape

,” where panelists from Jefferies International, Angelini Ventures, and Novo Holdings will examine how companies can secure funding in a tightening capital market, from venture rounds and initial public offerings to mergers and acquisitions. Funding is of particular relevance for technology-driven companies that require significant investment to scale advanced manufacturing platforms.

Meanwhile, in the therapeutic space, the session titled “

Scaling the melody of innovation for rare diseases

” will focus on development and commercialization hurdles for ultra-targeted therapies. Panelists from Ipsen, TVM Capital, and DEBRA Research will address regulatory and patient access complexities that shape the economics of manufacturing for rare conditions.

A day in the life of an experienced dealmaker

,” featuring experts from Bayer, IPSEN, and Forbion on the current state of life sciences transactions

Longevity: Stirring up investment and healthcare innovation

,” with WLAN Holding and Insilico Medicine exploring diagnostics, therapeutic pipelines, and the socio-economic realities of aging populations

Composing the next era of women’s health

,” with representatives from Freya Biosciences, ReproNovo, M Ventures, and the Bill & Melinda Gates Foundation on the intersection of investment, technology, and clinical innovation

How does hybrid engagement expand access?

The conference will conclude its in-person program with a networking reception at Vienna’s Hofburg Palace, hosted in collaboration with LISAvienna. To extend engagement, BIO-Europe will also offer two days of virtual partnering on Nov. 11–12, 2025. This hybrid format continues to broaden accessibility and ensures that companies can connect beyond geographic limitations, strengthening opportunities for cross-border collaborations, according to EBD Group in its release.

The relevance of BIO-Europe extends beyond the immediate networking value. By convening leaders from pharma, biotech, and investment communities, the conference highlights how drug development is increasingly dependent on partnerships that bridge scientific innovation, manufacturing capabilities, and commercialization expertise (2). For professionals focused on advancing biopharmaceutical technologies, the meeting provides insight into where investment is flowing, which therapeutic areas are prioritized, and how companies are navigating technical and regulatory bottlenecks.

As biomanufacturing becomes more complex—driven by cell and gene therapies, exosomes, and highly targeted biologics—the role of strategic partnerships underscored at BIO-Europe remains central to the industry’s ability to deliver next-generation medicines (1,3).

1. EBD Group. BIO-Europe 2025: Vienna Prepares to Welcome Global Biopharma Leaders. Press Release. Sept. 24, 2025. https://informaconnect.com/bioeurope/
2. Wu, X.; Knockaert, M.; Blasi, P. Collaborative Innovation During the Drug Discovery and Development Process. 

Cell and Gene Therapy Biomanufacturing Market—A Global and Regional Analysis: Focus on Product Type, Application, Usage, End User, and Region—Analysis and Forecast, 2025-2035

The 31st annual BIO-Europe conference in Vienna will gather over 5,700 attendees from more than 3,000 companies in the biopharmaceutical industry. The event emphasizes the importance of early partnerships in drug manufacturing and commercialization. Key sessions will address Europe's role in healthcare innovation, biopharma investment strategies, and challenges in rare disease therapies. The conference will also feature discussions on life sciences transactions, aging population healthcare, and women's health. A hybrid format, including virtual partnering, aims to enhance accessibility and foster cross-border collaborations.

Vienna to host BIO-Europe 2025, connecting top biopharma companies for collaborations and pipeline development.