Biopharmaceutical Manufacturing: Strategies For Navigating Raw Material And Process Changes

Explore the regulatory and technical elements involved in changing biopharmaceutical manufacturing processes, particularly in regard to the use of different chromatography resins. This article emphasizes the importance of risk assessments in understanding potential impacts on product quality, safety, and cost. Changes must be reported to the FDA and EMA using their respective classification systems. This blog also highlights the need to assess the supplier and materials when considering a change in resin material, noting the importance of a supplier's quality systems, technical expertise, and business practices. Material risks for resins fall into three categories: materials/solvents used in manufacturing, solvents used as preservatives, and leachables from the base matrix or the ligand. These regulatory guidelines and communication with regulatory authorities ensure product safety, efficacy, and quality.