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Biotech Making Facility to Make Genome-Edited, Off-The-Shelf CAR-T Therapies

Accuracy BioSciences, one of the biotechs working with so-called off-the-shelf chimeric antigen receptor T-cell (CAR-T) therapies, last year bagged $110 million in a Series B round. Some of that cash has gone toward constructing out a manufacturing facility at its Durham, North Carolina, headquarters it states will be up and running by the end of the year.

The facility will at first be used for its clinical work in oncology but has the potential to be a commercial launch facility with the capacity to generate up to 10,000 doses of CAR-T cell therapies and 4,000 treatments of gene therapies per year, the company says.

A company spokesperson stated the facility is part of a $26 million expansion Precision BioSciences has undertaken in North Carolina. The facility has ten full-time staff with a forecast capacity of 24, she said.

The facility is currently going via commissioning, qualification, and validation ahead of its fourth-quarter launch. Precision says the multiproduct facility is made to produce three different drug substances: allogeneic CAR-T cells, messenger RNA containing formulations development and adeno-associated viral cross product.

CAR-T products on the market are designed and manufactured on an eye to eye basis, unique to every individual patient.

Precision’s CAR-T product applicant use T cells from qualified donors, and they are manufactured in massive batches and cryopreserved to be shipped and stored. They can then use off the shelf for different treatments.

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