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Laboratory Test Request

FDA GMP Gene Therapy Lot Release

Project Description

LONG-TERM TESTING FDA GMP Bioanalytical Laboratory needed for GMP method validation, product qualification and lot release testing of a gene therapy product using Assay: density using the oscillating tube densitometer

If method validated, need specific product qualification or equivalent.
For test result, require raw data and certificate of analysis.

Project Information

Number:18-01596

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,Biotechnology,Cell Lines and Cell Cultures,Gene Therapy,Genomics and Genetics,Immunotherapy and Immunotherapeutics,Life Sciences,Personalized Medicine,Pharmaceuticals ,Pharmacogenomics PGX,

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