FDA GMP Gene Therapy Lot Release

Other Biopharmaceuticals testing, analysis, scientific research and development, inspection, certification, engineering, failure investigation, and product development needs include :

In vitro bioassays: Laboratory tests conducted on samples to assess the potency and toxicity of biopharmaceutical products Testing
Immunogenicity assays: Tests to evaluate the immune response induced by biopharmaceuticals Testing
important for safety assessment Testing
Stability testing: Assessing how the quality of a biopharmaceutical varies over time under the influence of environmental factors like temperature and light Testing
Purity and impurity analysis: Techniques such as chromatography and mass spectrometry are used to determine the purity levels and identify any impurities in the products Testing

Learn more about biopharmaceuticals testing and research