AAV Lot Release Testing

Ensuring the safety, quality, and consistency of adeno-associated virus (AAV) vectors is essential for successful clinical and commercial gene therapy programs. A well-defined lot release testing strategy confirms that each manufactured batch meets strict specifications for identity, purity, potency, safety, and regulatory compliance while achieving critical quality attributes. Because testing requirements evolve across the manufacturing lifecycle, evaluation transitions from broad process monitoring at bulk harvest to highly controlled, specification-based testing for drug substance and drug product, followed by stability testing throughout product shelf life.

Minaris Advanced Testing brings over 40 years of biosafety expertise to deliver comprehensive AAV lot release testing. Utilizing advanced PCR/ddPCR platforms, next-generation sequencing, and rapid microbiological methods, these GMP-compliant services support safety, identity, purity, and potency evaluations to accelerate program timelines.

Download the full flyer to review complete testing panels and turn-around times.