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Laboratory Test Request

FDA GMP Biopharma Container Closure Testing

Project Description

Biopharmaceutical needs FDA GMP Packaging Laboratory for Container Closure Integrity test (CCIT) with validated method.The package integrity verification will be performed on the final drug product as release and stability test.The drug product, is water based, supplied as a liquid in 15 ml glass vials stored at 5°C under nitrogen.

Project Information

Number:19-00371

Industry:Biopharmaceuticals

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Other biopharmaceuticals laboratory services.

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

Biologics,Biopharmaceuticals,Biosimiliars,Biotechnology,Pharmaceuticals ,Proteins and Peptides,Packaging,Containers,

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