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With more than 30 years of experience in biologics services, Catalent’s Paragon Gene Therapy provides industry-leading process development, scale-up, and cGMP manufacturing services for leading innovators of transformative therapies.
With more than 30 years of experience in biologics services, Catalent’s Paragon Gene Therapy provides industry-leading process development, scale-up, and cGMP manufacturing services for leading innovators of transformative therapies. It specializes in scalable adeno-associated virus (AAV) platforms across multiple serotypes, next-generation vaccines, and oncolytic immunotherapies.
Responding to the huge growth in the gene therapy market, Paragon Gene Therapy has increased its capacity, and last year announced the opening of a new commercial manufacturing center in Harmans, MD. Since its $1.2 billion acquisition by Catalent in May 2019, Paragon has also assumed the leases to two of Novavax’ product development and manufacturing facilities, including its state-of-the-art manufacturing equipment and experienced workforce, to further accelerate the growth of its gene therapy capabilities.
Together, Paragon Gene Therapy’s facilities in the greater Maryland area total more than 400,000 square feet and boast the talent, technology, and the focus on quality necessary to support partnerships with more than 20 industry-leading gene therapy companies. Capabilities include a process development and clinical-scale facility to support projects to Phase 2; and manufacturing with up to 10 cGMP suites and several 500-liter and 2000-liter single-use bioreactors, as well as fill/finish, and testing laboratories to support late-stage clinical and commercial gene therapy production.
Since 2016, Paragon Gene Therapy has produced more than 100 clinical cGMP batches across 40 programs with many of the leading gene therapy developers worldwide.