(191av) GMP Flow Chemistry Platforms: A CDMO Perspective on Enabling the Next Generation of Clinical-Stage API Manufacturing

The pharmaceutical industry pipeline has moved from a strong focus on high-volume blockbusters to a more balanced approach, towards lower-volume targeted therapies – such as those for specific cancers and rare diseases – driven by advances in disease biology and personalized medicine.[1] This shift is accompanied by increasing chemical structure complexity and potency of active pharmaceutical ingredients (APIs),[2,3] heightening the urgency to bring these treatments to patients faster and more reliably.

Meeting clinical-stage supply demands under these new conditions requires not only speed but also robustness. Batch failures or delays can severely impact development timelines. Continuous manufacturing (CM), particularly flow chemistry for drug substance, presents compelling advantages over traditional batch processing—enhancing safety, scalability, process control, and efficiency. However, widespread adoption of flow chemistry in GMP API manufacturing remains limited, especially within the contract development and manufacturing organization (CDMO) landscape.[4]

From a CDMO perspective, the challenge lies in balancing flexibility with compliance. Flow chemistry often necessitates bespoke equipment to optimize process performance, but this adaptability must coexist with the demands of a regulated GMP environment. This brings capital and operational complexities, particularly for multiproduct facilities managing high variability in chemical processes.

This poster presents a critical view on the future of flow chemistry in clinical-stage API manufacturing from the CDMO standpoint. We explore the potential of modular, reconfigurable flow chemistry platforms as enablers of agility, to accommodate diverse process requirements maintaining GMP standards, and flexibility to meet variable clinical supply needs. Such a platform also benefits from the remaining features of flow chemistry such as the level of containment to handle potent compounds and the easier integration of important technologies such as photochemistry and electrochemistry.

References

[1] Citeline Clinical (2025), Pharma R&D Annual Review 2025. [2] J. Med. Chem. 2023, 66, 18, 12710

[3] J. Med. Chem. 2023, 66, 18, 12739

[4] API Innovation Center (2025), Benefits and Barriers to Adopting Advanced Manufacturing Technology in the Pharmaceutical Industry.