BioReliance^® Viral and Gene Therapy Manufacturing

Our Carlsbad, California facility has completed both a U.S. Food & Drug Administration (FDA) Pre-License inspection and a European Medicines Agency (EMA) Marketing Authorization inspection, making us the leaders in quality inspection readiness for viral gene therapies. Our extensive history, expertise, and quality systems allow us to be your partner for successful scale-up, process validation, clinical trials, and commercial launch.

Related Product Resources

Flyer: cGMP Viral Product Development and Manufacturing
Webinar: An Integrated Approach to Ensure Viral Vector and Gene Therapy Commercial Readiness
Webinar: Promises and Challenges of Manufacturing and Testing Viral Producer Cell Lines
White Paper: The Importance of Scalability in Viral Vectors

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Meeting regulatory expectations together

We have a deep understanding of regulatory expectations and safety evaluations for viral vectors. As a full-service gene therapy contract development and manufacturing organization (CDMO), we integrate BioReliance^® biosafety testing services into our workflow to support you at every step of drug development. Our full range of in-house services comply with good manufacturing practice (cGMP) standards for viral vector characterization and testing, including virus seed stock characterization, droplet digital PCR for virus titer, and custom-designed potency assays.