As a product innovator with more than 20 years of contract manufacturing experience, we have produced over 1,000 batches of virus to support gene therapy development from clinical through commercialization. Backed by deep know-how with a broad range of virus types and different processes, our production engineers employ an array of technologies to meet your program’s needs for:
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.
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.
Experience with a broad range of virus types makes BioReliance® a proven partner at every stage of the viral and gene therapy life cycle