GMP Lot Release Testing
Drug Product or Lot is the term used to describe the final vialed drug material which can be administered to patients. This material must be tested using a variety of methods as outlined in the drug master file which confirms the drug product specifications. Final product (vialed) testing to be considered includes:
Identity of the product is dependent on the nature of the product itself: examples of identity testing include the following; specific PCR test, sequencing analysis, SDS-PAGE, restriction enzyme analysis.
Purity of the cell-based product can perhaps be more re-defined as consistency. These products are known to have mixed populations and therefore specifications should be set to reflect this.
Product potency will be defined in the specification of the product, the design of the assay varies but normally should cover both functional and marker-based assays. Guidelines suggest that the assay should be at least semi-quantitative and show correlation with the intended therapeutic effect.
BioOutsource also perform the following test for final product:
- Sterility Testing
- Titre Determination
- Extractable Volume
- Residual Host Cell Protein
- Residual Host Cell DNA
Contact our experts to discuss your cGMP lot release testing requirements.