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CGMP Manufacturing

Versatility, superior quality, and unparalleled partnership are the defining features of our industry-leading CGMP manufacturing services. The Gene Therapy team at Catalent combines leading expertise​ in AAV recombinant viral vector technology and scale-up with state-of-the-art CGMP facilities, including our FDA approved commercial Harmans/BWI facility. Our expert manufacturing teams are dedicated to optimal virus production and focused customization for your product. Each facility has multiple upstream and downstream manufacturing suites to accommodate parallel manufacturing campaigns.

At Catalent, we have produced a large number of clinical batches for trials with more than 90 AAV CGMP manufacturing batches executed in less than three years. We have a superior track record with both suspension and adherent transient transfections with over 50,000L of transfected HEK293 cultures over multiple campaigns and over 50 CGMP iCELLis® 500 productions respectively.

Additionally, we have completed more than 4,000L of HEK293 suspension HSV co-infection culture combined between multiple campaigns and various HSV production campaigns in HYPERStacks® vessels.

Finally, our robust supply-chain management allows us to secure the critical manufacturing materials that will aid in de-risking your therapeutics.

Backed by years of success and an industry-leading team of scientists, Catalent Gene Therapy is your partner for complex biopharmaceutical manufacturing.

iCELLis is a trademark of Pall Corporation.
HYPERstack is a trademark of Corning Incorporated.