Implementation of the BPOG Extractables Testing ProtocolsWorking with Multiple Single-Use Components

摘要

Single-use technologies offer significant advantages over traditional stainless-steel solutions for biopharmaceutical manufacturing. Reductions in setup times, cleaning and cleaning-validation costs, elimination of cross-contamination risks, and smaller footprints are just some of the benefits they provide. Although adoption of single-use systems (SUS) for commercial manufacturing is expanding, concerns persist that extractable and leachable (E&L) compounds from plastic SUS components potentially canleach into final drug products and compromise efficacy and safety. Those concerns are magnified amid the growing number of SUS suppliers and the complex supply chain for SUS and disposable components. In addition, although all equipment used for manufacturing biologic drug substances and drug products must meet current good manufacturing practice (CGMP) requirements (l) and be free of materials that can affect the safety or efficacy of drug products (2), no specific regulatory guidelines or industry standards pertain to performance of E&L studies for SUS.