Manufacturing Incidents Investigation Involving Raw Materials Used For Biopharmaceutical Products

Raw materials used in biopharmaceutical manufacturing processes are critical to the quality of biopharmaceutical products. These materials include media components for cell culture, column resin for purification, excipients and containers for final drug product. The quality of final drug products depends on the quality of all the raw materials used during the manufacturing processes. Raw materials for biopharmaceutical manufacturing are not regulated to the same degree as drug substance and hence impurities, contamination, deficiency of critical components in raw materials can impair the product quality of biopharmaceuticals. For instance, contamination of heparin, glass delamination of vials, and tungsten residue in glass syringes can critically impact drug products.
In this presentation, we report a number of incident investigations of lot failures during biopharmaceutical manufacturing that were caused by raw materials. They include black particles found in prefilled glass syringes, tungsten residues that impacted product stability, and plastic particle residues found in prefilled plastic syringes.