Compliance with quality control (QC) standards is a basic requirement for products manufactured under good manufacturing practices (GMP) conditions. In this post we will explore the main compendial QC tests that ensure cell and gene therapies are safe for use in patients, and important considerations for integrating QC testing into the manufacturing process.
Compendial & Non-Compendial Tests
Compendial tests are standardized methods that are basic requirements for manufacturing release. Non-compendial tests are additional analytical methods that may be custom requirements for certain products. In cell and gene therapy manufacturing, non-compendial tests are an important consideration, and often prove to be a technical bottleneck that should be addressed during the product and process development stages.