Article: Scaling Up From Bench Through Commercialization

By Maninder Hora

A biopharmaceutical scientist's scale-up journey often starts when he or she gets some sketchy information from a research colleague on "an exciting molecule with great biological activities!" The challenge begins with establishing a cell line, then involves scaling up the process to a pilot scale and producing initial material by means of a suboptimal process. Process knowledge increases exponentially from the first experiment until when a company has finally scaled its process up to a commercial scale. Always faced with timeline, resource, and cost pressures, process engineers make their way from a first-in-human pilot process to the eventual, commercial-scale process. And suddenly it's time to lock down and validate that process. That's when you realize that the ease of process validation is inversely proportional to the extent of your process knowledge.

Reprinted with permission from BioProcess International 5(7):S24-29 (September 2007)

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