The Risks of Single-Use Bioprocess Containers

摘要

The screening of the final packaging components of human drug products for extractables and leachables has become commonplace in the 15 years since the FDA released their Container Closure Systems for Packaging Human Drugs and Biologies. With the increase in prevalence of single-use systems for biomanufacturing, these components require the same scrutiny. The regulation applicable to bio-processing/manufacturing components (CFR Part 211.65) states: "Equipment shall be constructed so that surfaces that contact components, in-process materials, or drug products shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements."1-2 Drug applications to the FDA are expected to provide a safety evaluation, based on the extractables and leachables profile, of the highest risk components that are in closest contact with the drug. For biologies these components not only include the final container/ closure system but also components associated with the biomanufacturing process.