Catalent Launches UpTempo Virtuoso AAV Platform to Reduce Gene Therapy Development Time and Accelerate Pathway to Clinic

SOMERSET, N.J. – Catalent, the global leader enabling biopharmaceutical, cellular, genetic and consumer health partners to optimize the development, launch and delivery of better treatments to patients across multiple modalities, introduced its new UpTempo Virtuoso platform process for CGMP development and manufacturing of adeno-associated virus (AAV). The UpTempo Virtuoso platform standardizes and streamlines many time-consuming steps in AAV manufacturing to dramatically reduce the time from gene to clinic and enable rapid first-in-human clinical assessment.

The suspension-based UpTempo Virtuoso platform includes optimized standard protocols for cell culture, transfection, and downstream purification, as well as standardized materials nomenclature to simplify critical supply chain and materials qualification. The new platform is designed to provide a high titer, CGMP-ready process capable of producing a drug product for clinical evaluation in nine months, potentially cutting the conventional development path in half and delivering more predictable results. Customers using this new process will also have access to Catalent’s integrated plasmid DNA (pDNA) supply chain, providing additional potential to reduce development time.

“As one of the first CDMOs to successfully develop a suspension-based transient transfection process, and with our deep and specialized viral expertise and extensive experience in over 70 viral vector programs, we have built this new process with the goal of providing our customers with a reliable, repeatable and scalable path to the clinic,” said Manja BoermanPh.D., Chair, Cell and Gene Therapy at Catalent. “As the gene therapy pipeline expands into a broader disease portfolio and in anticipation of increasing regulatory demands, our optimized and standardized CGMP manufacturing process is designed to meet strong CMC submissions for AAV gene therapy products, while offering customers the advantage of shorter lead times.’

Catalent’s The global network of clinical and commercial pDNA and viral vector facilities offers horizontally integrated solutions to support advanced gene therapy programs in the clinic. His Marylandvirus-based includes viral vector programs in Baltimore and Gaithersburgand commercial-scale manufacturing at its FDA and EMA-approved facility in Harmans/IBB. The production of pDNA, from research material to CGMP-grade material, is carried out at Rockville, Marylandand Catalent’s European Center of Excellence in Gosselies, Belgium.

ABOUT CELL AND GENE THERAPY

Catalent Cell & Gene Therapy is a leading partner in the technology, development and manufacturing of advanced therapies. Its comprehensive cell therapy portfolio includes a wide range of expertise on a variety of cell types, including CAR-T, TCR, TIL, NK, iPSC and MSC. With deep expertise in developing, scaling up and manufacturing viral vectors for gene therapies and viral vectors, Catalent is a full-service partner for plasmid DNA, adeno-associated viruses (AAV), lentiviral vectors and other viruses, and oncolytic viruses. An experienced and innovative partner, Catalent Cell & Gene Therapy has a global network of dedicated development, clinical manufacturing and commercial facilities for small and large scale programs.

IN REGARDS TO CATALENT

Catalent is the global leader enabling pharmaceutical, biotechnology and consumer healthcare partners to optimize the development, launch and supply of products throughout the lifecycle for patients worldwide. With broad and deep scale and expertise in development sciences, delivery technologies and multimodal manufacturing, Catalent is a preferred industry partner for personalized medicines, consumer healthcare brand extensions and blockbuster medicines.

Catalent accelerates more than 1,000 partner programs and launches more than 150 new products each year. Its flexible manufacturing platforms at more than 50 global locations supply more than 70 billion doses of nearly 7,000 products annually. Catalent’s the expert workforce exceeds 19,000, including more than 2,500 scientists and technicians.

Based at Somerset, New Jerseythe company generated $4 billion in revenue for its 2021 financial year. For more information, visit www.catalent.com

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