Considerations For Successful Upstream Manufacturing Process Scale-Up

By Sungkeum Seo, Ph.D., Lead of Upstream MSAT, Samsung Biologics, and Jeremy Weisshar Associate Director, Drug Substance MSAT, Samsung Biologics

A CDMO’s ability to scale seamlessly between bioreactor sizes is critical when adopting a client’s manufacturing process. With so many facets to consider as part of both cell culture manufacturing and tech transfer, it is essential to partner with a CDMO that exhibits expertise and a proven track record of success relevant to tech transfer, whether the process is scaled up, scaled down, or remains the same volume.

Scale-up challenges typically occur when the bioreactors used following process transfer differ significantly in geometry and design from the bioreactors used during initial process design and/or production. The different mixing methods and sparging strategies applied to various reactors can compromise cell culture performance.

Starting tech transfer early allows obstacles to be addressed methodically, which can avoid costly delays. Key to this strategy is risk mitigation through gap assessments for raw materials, equipment, and process.

Most companies seek a CDMO partner capable of guiding them through the scale-up and tech transfer process, as well as the ability (and flexibility) to scale seamlessly between bioreactor sizes while overcoming associated challenges. To this end, a partner with demonstrated experience and expertise — who can serve solely as a manufacturing partner, if needed, but can assist in development to any extent necessary — is ideal.