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Laboratory Test Request Details

Biopharmaceuticals Test Request


Request: 18-01596

Status: Closed


Title:

FDA GMP Gene Therapy Lot Release

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.


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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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