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