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Abzena to open new biologics GMP manufacturing site in the US

11 Jan 2021

The new facility will house up to 12 X 2000-L bioreactors and will be equipped to handle existing and new advances in manufacturing

Abzena, a global research organization, will add a sixth global site that will augment current good manufacturing practice (cGMP) manufacturing capacity for mammalian biologics.

The new facility will be based in the US and will accommodate Phase III and commercial manufacturing.

According to the company, an increase in customer demand for commercial-scale 2000-L single-use bioreactors across a wide range of therapeutic areas has driven this expansion.

Last year, the company successfully launched its second cGMP facility in San Diego. Previously, the company's San Diego site focused primarily on developing and manufacturing Phase I and II clinical trial materials. The expansion has enabled the company to provide seamless project integration for our customers as they move into Phase III and ultimately commercial manufacture.

A phased approach to construction will initially allow four modular suites with each suite including up to two 2000-L bioreactors, followed by the addition of two further 2000-L suites.

In addition, the site will be equipped to handle existing and new advances in manufacturing such as continuous manufacturing and perfusion with manufacturing commencing in mid-2022.

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