Wednesday, September 9, 2020 Daily Archives

Catalent investing $130m to up US gene therapy capacity

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Catalent will add five additional Phase III through to commercial-scale manufacturing suites to its gene therapy campus in Harmans, Maryland. The US contract development and manufacturing organization (CDMO) cited growing customer pipelines and an increase in demand as the driver for the investment. Randy Hendrickson, VP Commercial Operations, Catalent Cell & Gene Therapy told us: “Upon completion in the first half of 2022, the facility will house multiple cGMP manufacturing suites with pre-seed, bioreactor, and downstream rooms alongside fill/finish, testing,…

September 9, 2020

As COVID disrupts FDA inspections, will liso-cel approval be further delayed?

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Coronavirus-related constraints mean the US FDA has not yet inspected manufacturing facilities in Washington and Texas, risking a delay in the approval of Bristol-Myers Squibb’s lymphoma CAR-T candidate liso-cel. Bristol-Myers Squibb added anti-CD19 targeting lymphoma candidate lisocabtagene maraleucel (liso-cel) to its pipeline through the $74 billion acquisition of Celgene. In May, the action date of the Biologics License Application (BLA) for the chimeric antigen receptor (CAR) T-cell therapy was extended by three months by the US Food and Drug Administration…

September 9, 2020

Automation: ‘The only way to truly scale cell therapy manufacture’ says Lonza

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Lonza says it has achieved a significant milestone with partner Sheba Medical treating its first patient with a CD19 CAR-T cell immunotherapy made using the automated point-of-care Cocoon technology. In March 2019, Swiss CDMO Lonza entered a partnership with Israel’s Sheba Medical Center to provide automated and closed CAR-T manufacturing using its point-of-care (POC) Cocoon cell therapy manufacturing platform. This week, Sheba and Lonza announced the first patient has been dosed with a CD19 CAR-T cell immunotherapy made using the…

September 9, 2020