Case Study – Glycogenesys

Glycomics-based Oncology Drug Process Optimization and Scale-up

Situation

A pharmaceutical company was commercializing a novel pectin-based oncology drug. Pilot scale manufacturing lots that were produced at CMOs had unexplained variations in product potency. The client needed to better understand the causal effects of process parameters on product quality to improve current operations and facilitate a smooth scale-up to commercial production.

Approach

IMPACT evaluated the existing manufacturing process and raw material stream and identified a number of potential areas for improvement. IMPACT then designed and implemented lab scale versions of key manufacturing operations and assisted the client in evaluating the process in their laboratories. IMPACT also performed an FMEA of critical areas of the process to further improve process reliability and robustness.

Results

IMPACT’s approach succeeded in identifying the sources of product variation, which resulted in greater product uniformity.