Facility-Fit-Driven Process Development For A Monoclonal Antibody (mAb)

Many processes developed at the bench fail to account for the physical and operational realities of a GMP manufacturing suite. This critical disconnect often leads to bottlenecks, including the need for oversized chromatography columns, extended cycle times, and high consumable use, ultimately inflating the cost of goods (COGS) and delaying timelines.

Discover an alternative path built on the facility-fit strategy. By modeling plant constraints early, focusing on high-capacity resin screening, and employing parallel upstream and downstream workstreams, it is possible to dramatically accelerate process transfer. See how this systematic approach successfully compressed a development timeline to just two months, reduced overall processing hours by more than 50%, and achieved a 25% reduction in COGS.