Development teams understand the molecule’s biology and design the product for the target patient population, while manufacturing teams offer insights on scale, equipment, robustness, and regulatory compliance.
Strategic Alliances in Bioprocessing and R&D: A Q&A with Dr. Manisha Desai of Bristol Myers Squibb
Key Takeaways
- Constrained resources and specialized technologies make integrated partnerships necessary to complement internal innovation and expand capacity beyond what any single organization can sustain.
- Speed gains occur when interdependent functions share a unified view, combining process design, scientific insights, and manufacturing operational knowledge to secure first-mover advantage.
Bristol Myers Squibb’s Dr. Manisha Desai, senior vice president of Product Development, notes how strategic bioprocessing alliances accelerate drug development by integrating R&D and manufacturing to scale complex biologics and ensure reliability.
Strategic partnerships have become a cornerstone of modern drug development, driving innovation across increasingly complex therapeutic landscapes. BioPharm International® discussed how these alliances are reshaping bioprocessing, biopharma R&D, and manufacturing workflows with
With more than 2 decades of expertise in
BioPharm: How are strategic partnerships reshaping bioprocessing and biopharma drug development ?
Dr. Desai (Bristol Myers Squibb): Partnerships have become foundational because the industry currently operates under constrained capital, compressed timelines, and increasingly specialized technologies. No single organization can sustain every necessary capability internally, necessitating a heavy reliance on external expertise to complement internal innovation and augment capacity. There is a fundamental shift from traditional fee-for-service models toward integrated partnerships where external technology capabilities are woven into the overall development landscape to help bring breakthrough treatments to patients.
Where do biopharma collaborations have the greatest impact on development speed?
Collaboration is most effective where work is highly interdependent and no single group has the full picture. In matrix environments, integrated partnerships allow development groups to combine scientific insights and process design with the operational knowledge of manufacturing teams to create robust processes. As science advances, teams must integrate partners with specialized understanding of evolving modalities to establish effective treatment paradigms quickly. Because speed is a critical business driver for first-mover advantage, companies must collaborate with external providers whose existing technologies are already a good fit for specific new modalities.
Why is early alignment between drug development and manufacturing teams critical?
Early alignment is vital because these teams provide complementary expertise. Development teams understand the molecule’s biology and design the product for the target patient population, while manufacturing teams offer insights on scale, equipment, robustness, and regulatory compliance. Marrying these perspectives ensures that processes developed at a clinical scale can withstand the rigor of commercial-scale operations. While traditional models featured a large difference between clinical and commercial scales, the rise of personalized medicine is narrowing this gap, making early integration even more important for developing appropriate processes for specific medicines.
How do external partnerships help scale complex biologics more efficiently?
Scaling complex biologics, such as bispecific or trispecific antibodies, requires deep biological understanding of traits like aggregation risk and immunogenicity during early development. External partners add value by bringing experience from a wide range of programs and diverse client portfolios. By leveraging their broader risk management expertise and proven solutions from previous assets, companies can anticipate potential challenges and design processes with both scientific integrity and operational feasibility. This ecosystem approach reduces late-stage surprises and helps preserve timelines for market entry.
Which manufacturing and process challenges are best addressed through collaboration?
Collaborations are particularly effective at solving challenges that span organizational and functional boundaries, including quality, supply, and downstream activities. By integrating the entire value chain, companies can optimize pathways and remove risks that occur when stakeholders operate in silos. This is increasingly important for biologics due to global pricing pressures, geopolitical forces, and economic instability, all of which require improved manufacturing efficiency to manage costs. As modalities evolve from simple monoclonal antibodies into complex forms like radiopharmaceuticals or cell therapies, partnerships with specialized technology providers and CDMOs [contract development and manufacturing organizations] are essential for maintaining a competitive development timescale.
How do partnerships ensure long-term biopharma supply chain reliability?
Strong partnerships between development, manufacturing, and supply chain teams help identify scale-related risks and operational challenges early in the lifecycle. For example, development teams must ensure a molecule can withstand the environmental rigors of different global climate zones, from sub-freezing temperatures to high humidity. By including supply chain and logistics experts as thought partners during the development cycle, companies can design products and processes that maintain stability and quality regardless of geographic location. This early engagement minimizes the risk of disruptions and ensures a continuous supply of medicine for patients worldwide.
What emerging trends are defining the future of biopharmaceutical partnerships?
Two major trends are currently reshaping the industry. The first is a shift in scientific paradigms. The second is a shift in digital technology. Scientifically, the industry is moving from high-volume ‘blockbuster’ products to high-value, low-volume personalized medicines, such as gene therapies, CAR-T [chimeric antigen receptor T cell] therapies, and antibody-drug conjugates. Digitally, there is a paradigm shift toward incorporating machine learning, large language models, and various forms of AI, including generative and agentic AI. Companies that successfully integrate these scientific and technological evolutions into their portfolios will maintain a competitive advantage and sustain their business in the future.





