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Catalent Adds New Cryogenic Capabilities at Shiga, Japan, Facility to Support Clinical Supply Demand for Cell and Gene Therapy Development

The Pharma Data

The expansion forms part of Catalent’s ongoing global strategy to increase its ability to handle, store and manage advanced therapies for clinical supply, and follows investments at its facilities in Philadelphia, Singapore, and Shanghai, China, in specialized, ultra-low temperature storage capabilities. With sites in the U.S.,

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Why demand is rising for secure and climate-controlled gene therapy services

Pharmaceutical Technology

Although only a small number of gene therapies have reached the market thus far, the industry is poised to grow quickly over the next few years. According to GlobalData’s clinical trials database, there are currently 1,231 planned and ongoing trials for gene therapies and gene-modified cell therapies alone.

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Untangling the Complexities of Cell and Gene Therapy Clinical Trials: A Supply Chain Perspective 

Pharmaceutical Technology

By Luisa Sterkel & Joana Loureiro , Tenthpin Consultants The promise and potential of cell and gene therapies (CGT) has emerged in the recent past and currently over 1.500 CGT are registered for clinical trials holding great hope for the treatment of challenging and uncurable diseases.

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Catalent Expands OneBio® Suite for Integrated Development, Manufacturing and Supply Across Biologic Modalities

The Pharma Data

Originally launched in 2019 for early-phase protein therapy development, OneBio Suite offers customers an integrated service to accelerate programs from development to manufacturing, including fill/finish and packaging, and support for clinical supply and commercial launch. At the BIO International Convention, Carey Connolly, Ph.D.,

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Oxford Biomedica and Beam Therapeutics sign CAR-T deal

The Pharma Data

The agreement also puts in place a three year clinical supply agreement for the two companies. Under the terms of the deal, Oxford Biomedica will receive an undisclosed upfront payment, with additional payment related to development and manufacturing of lentiviral vectors for use in clinical trials.

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J&J’s Carvykti and BMS’ Abecma Win FDA Approvals for Earlier Use in Multiple Myeloma

XTalks

Concerns of Early Deaths The expanded approvals come after the FDA had flagged reports of early deaths in clinical trials evaluating the therapies in earlier treatment line settings. 2seventy has been used to the struggles ever since it spun out of gene therapy biotech bluebird bio.

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Overcoming inefficiencies to improve access to cell and gene therapy 

Drug Discovery World

The cell and gene therapy (CGT) landscape has grown significantly in the past year. Between the 24 therapies already approved by the FDA 1 and a marked increase in clinical trials, widespread accessibility to precision medicine feels within reach.