Q&A

Scaling Up Bioprocesses Through A CDMO

Source: Cytiva
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Biopharma manufacturers face mounting pressure to accelerate development timelines while ensuring robust, scalable processes. Moving from lab scale to commercial production is far from straightforward—cells behave unpredictably at larger volumes, and rising titers introduce new downstream bottlenecks. Flexibility in manufacturing platforms, particularly single-use systems, is helping companies adapt by reducing capital costs and simplifying scale-up. Service partnerships are also playing a critical role, offering expertise in upstream and downstream development, analytical support, and cGMP manufacturing. At the same time, rare disease therapies present unique challenges: small clinical trial sizes require minimal material for human studies, yet non-clinical programs often demand significant quantities. Success hinges on understanding critical process parameters, leveraging advanced technologies, and ensuring seamless technology transfer.

Learn how industry leaders are tackling these hurdles and what strategies are shaping the future of biopharma manufacturing.

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