Our client is a small molecule drug discovery and development company that acquired a commercially launched biologic pharmaceutical. Process variability in the fermentation of the drug was creating N-terminal variants, preventing the product from being manufactured reliably.
Pharmaceutical Advisors assembled the right cross-functional team of Bio-Analytical, Fermentation, and Bio-Manufacturing experts. We supported the client through the investigation, experimentation, and implementation phases of the project. Assessing the process and existing data for root cause of process variability. We selected and directed the outsourced supplier to identify weaknesses of the existing process and analytical methods supporting the process.
Identified the most likely sources of variability, establishing vendors for new analytical methods and fermentation development.
Designed and executed an experimental protocol to definitively assign root cause, designed cost-effective scale-up plans to manufacture the revised process at scale.
Provided the client with the root cause of variability in the face of a complex web of confounding factors, and a cost-effective solution to product variability, avoiding product withdrawal...Protected a key source of revenue during a critical phase of growth for a young and growing Bio-Pharmaceutical Client.