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Process characterization (PC)/process validation (PV)
for Biologics License Application (BLA)
Lentiviral vector, usually being used as the drug substance (DS) of advanced therapies, directly affects the quality, safety and effectiveness of drug product (DP). Therefore, the commercial production of lentiviral vectors must comply with cGMP standards to ensure product quality and safety. And sufficient process characterization (PV) and process validation (PV) will be carried out to support the drug to obtain marketing authorization.
GenScript ProBio has established a viral vector GMP workshop that meets the cGMP requirements to provide customers with CDMO service, including process characterization (PC), process verification (PV), and commercial manufacturing etc.