A New Era for Large Molecule Biomanufacturing: Insights from the CPHI Frankfurt 2025 Digital Event
Given the current complexities and challenges facing large molecule biomanufacturing, senior leaders believe it is imperative for industry to redefine the rules of competition, improve innovation, and be more intelligently connected.
Large molecule and new modality drugs have been gaining popularity over the past several years thanks to their ability to treat a variety of diseases that were previously thought to be untreatable. However, these therapies are inherently more complex than their traditional counterparts and, as such, face more challenges across the development and manufacturing lifecycle.
Focusing on large molecule biomanufacturing, a panel of top executives convened ahead of CPHI Frankfurt 2025 to evaluate some of the most pressing issues facing industry around where biomanufacturing stands and where it needs to go next (1). Moderated by Elliot Berger, Board Director at Orientation Marketing and former Chief Marketing Officer at Catalent, the panel comprised: Gil Roth, President of the Pharma and Biopharma Outsourcing Association; John Chiminski, former Chair and CEO of Catalent; and Julien Meissonnier, former Chief Scientific Officer at Catalent and senior advisor.
The State of Large Molecule Manufacturing in 2025
Meissonnier opened the panel discussion on the evolving landscape of biologics and new modalities, highlighting two areas — therapeutic proteins and cell therapies — as pivotal to the sector’s evolution (1).
Noting that the industry has reached record activity across Phase II and Phase III programs, particularly in modalities like antibody-drug conjugates (ADCs) and bispecifics, Meissonnier pointed out that large molecule manufacturing has not evolved fast enough given the complexity of the molecules. With the efficiency of traditional fed-batch systems plateauing, Meissonnier highlighted the opportunity for CDMOs and drug developers to move beyond scaling capacity and pursue genuine manufacturing innovation.
As an example, Meissonnier pointed to Prolific Machines' use of disruptive technology; using light to precisely control cell expression and modify post-translational profiles in real time through artificial intelligence (AI)-guided automation. Such innovations represent a long-overdue shift from incremental optimization toward step-change transformation.
Meissonnier concluded with pragmatic advice for CDMOs navigating this inflection point: define long-term manufacturing that includes AI integration, identify areas where innovation can be owned, and bring in external expertise to accelerate execution. Capacity, he cautioned, is no longer the only measure of operational strength and that success will belong to the organizations that integrate digital manufacturing, rapid analytics, and automation to deliver consistent results.
AI for the CDMO Renaissance
AI featured as a unifying thread amongst the conversation, with panellists agreeing that it will be the most transformative tool in the next decade of pharmaceutical manufacturing.
Chiminski focused on the crossover between AI and biologics process design by discussing how AI integration will enable CDMOs to accelerate design of experiment (DOE), shorten cycle times, and cut production costs without compromising product quality. “I think [AI is] going to be a second renaissance for CDMOs in terms of what it can do from a quality excellent standpoint, from a cost standpoint, (and) really improving the overall manufacturing processes,” he said.
Additionally, Chiminski spotlighted an important structural dynamic within the CDMO sector — the rise of smaller, highly specialized service providers. Although large-capacity facilities continue to dominate for blockbuster biologics, most drugs in development today will not require 10,000- or 20,000-liter reactors, and that 5,000 liters or below will be the true growth frontier. Smaller CDMOs are already demonstrating a level of process sophistication that rivals their larger counterparts to encourage flexibility, innovation, and closer client collaboration.
Policy Pressures and Tariff Impacts on the Supply Chain
From technology to policy, Roth emphasized that even without new pharma-specific tariffs, reciprocal trade measures between the U.S. and EU are already raising costs across the supply chain. Consumables have been hit by 15% import tariffs which threaten to squeeze already tight margins.
Roth also mentioned the broader policy shifts. Under the previous U.S. administration, large molecule products received a longer exclusivity period before being subject to Medicare price negotiations, which prompted some sponsors to favor biologics over small molecule development. He noted that while this longer exclusivity provided temporary relief for large molecule manufacturers, regulatory guideline changes from the new FDA — particularly for cell and gene therapies — are expected to create uncertainty.
“We're already seeing it with a couple of cell and gene products and smaller orphan oncology products where the R&D pathway was pretty clearly defined and is now being changed post Phase III,” Roth added. “This is creating uncertainty for especially smaller R&D shops in terms of whether what they're advancing into the pipeline will actually make it in based on their prior FDA conversations.”
Following on from the panelists' discussions, industry CEOs and executives presented their take on urgent and important challenges facing the large molecule market in a series of rapid fire presentations (1).
From Resilience to Regionalization: Rethinking Global Capacity
Paul A. Josephs, President & CEO at Lifecore Biomedical highlighted that U.S. policy shifts are significantly reshaping the economics of domestic drug production, with the reshoring of pharmaceutical manufacturing driven by supply chain vulnerabilities revealed during the COVID-19 pandemic. The heightened geopolitical tension and concerns about national security have further accelerated efforts by policymakers and drug sponsors to regionalize production back to the U.S.
Lifecore believes that their advantage now lies in regulatory alignment and the ability to serve as a strategic, reliable source of supply for sponsors who view national security as integral to their supply chain risk management. Lifecore emphasizes that the winners in this new environment will be those investing not only in expanding manufacturing capacity but also in workforce development and advanced manufacturing technologies. Leveraging domestic CDMOs and capabilities will help drug sponsors shorten supply chains and mitigate risks even without owning full manufacturing capabilities themselves.
Eduard Viladesau Franquesa, Managing Director of HIPRA Biotech Services echoed the same sentiments. Amid concerns from customers regarding funding, tariffs, drug approval timelines, and regulatory criteria, good business sense and value-driven partnerships would prevail. He highlighted the need for biotech's to align with partners who bring scientific expertise, technical excellence, and a collaborative mindset essential for accelerating development timelines to overcome the hurdles impacting medicine access.
Cell Therapy, Continuous Production, and the Next Frontier
Although cell therapies, such as CAR-T and allogeneic constructs, have delivered groundbreaking results, manufacturing scalability remains a bottleneck. Addressing these challenges through increased capacity and advanced capabilities will enable scalable, reproducible, and cost-effective production of cell therapies, ensuring patient access without compromising quality or efficacy.
Russ Miller, VP, Global Sales and Marketing at Enzene Biosciences discussed his company’s inauguration of its fully connected continuous manufacturing (FCCM) facility in Hopewell, New Jersey — its first major manufacturing investment in the U.S. The state-of-the-art site leverages Enzene's proprietary EnzeneX 2.0 platform — the world’s first FCCM for biologics, supported by advanced process analytical technology to enable real-time monitoring and control that achieves yields up to ten times higher than conventional methods.
Isabel Feuerstein, Head of Business Development for Europe and Asia at Novartis Contract Manufacturing, highlighted her company’s 40 years’ experience in offering comprehensive expertise across biologics, cell and gene therapies, RNA therapeutics, small molecules, and fill/finish services.
Through major investments, Novartis is increasing manufacturing capacity to meet global demand; investing USD 500 million in a new state-of-the-art production facility in Austria, allocating USD 250 million to expand production lines and improve productivity in Singapore, and launching a new viral vector facility in Slovenia to support cell and gene therapies, Novartis is positioning itself to help both emerging biotech and established pharmaceutical leaders achieve their goals through advanced manufacturing capabilities and strategic collaboration.
Jonathan Haigh, Head of UK Sites at FUJIFILM Biotechnologies, discussed how his company continues to position itself as a leading end-to-end CDMO dedicated to biologics and advanced therapies. A new site in North Carolina is among the largest cell culture biomanufacturing facilities in North America, supported by its flagship state-of-the-art bioprocessing site in Denmark. The company combines technological innovation — including proprietary platforms like ApolloX for mammalian cell line development, and MaruX for continuous manufacturing — with a clear commitment to sustainability, global reach, and customer collaboration.
Specialized Expertise and Tailored Capabilities
As biopharmaceutical contract manufacturers continue to innovate, there remains significant opportunity for further specialization as the industry evolves to meet increasingly complex biologic and drug formulation needs.
Nanoform positions itself as a strategic partner by offering innovative nanoformulation technologies to enable higher drug loads for subcutaneous delivery. Achieved via a gentle manufacturing process that maintains protein structure and activity, their proprietary technology allows precise control over particle size and morphology, resulting in highly flowable powders that improve formulation properties that are supported by a fully scalable process and clear GMP pathways.
Lifecore Biomedical’s proprietary filtration technologies, sterile injectable manufacturing, and aseptic filling and packaging enables sterile processing of such challenging formulations while minimizing product loss. Offering phase-appropriate manufacturing environments provides flexibility for early-stage development that reduces costs and timelines. Lifecore’s core capabilities integrate process development, analytical testing, and engineering services alongside fill/finish operations, making them a preferred partner for complex formulations requiring precise control and innovation.
HIPRA Biotech Services' strong European infrastructure focuses on mammalian and microbial platforms. Their integrated CDMO services encompass process development, analytical methods, clinical trial manufacturing, and commercial-scale production with emphasis on quality and regulatory compliance tailored to European and global markets. Through investment in innovation, the company helps to address current geopolitical and market pressures by aligning manufacturing capabilities with client needs for agility, resilience, and quality.
Outlook: Innovation, Agility, and Policy Alignment
The panellists and participating executives agreed on a common message: it is a pivotal moment for large molecule manufacturing, with scientific progress, government policy, and digital transformation colliding to redefine the rules of competition. The themes from this preview panel — automation, partnership, and resilience — set a clear agenda: to make large molecule manufacturing not only more innovative but more intelligently connected.
Reference
Informa. Large Molecules and New Modalities: Top Pharma Execs on Burning Challenges and Promising Solutions to Explore. Special Informa Digital Event in Partnership with Orientation Marketing, Oct. 16, 2025. Available On Demand.