Abzena, a biologics and bioconjugates specialist, has announced the addition of a 6th global site that will augment cGMP manufacturing capacity for mammalian biologics. This expansion is driven by an increase in customer demand for commercial-scale 2000 L single-use bioreactors across a wide range of therapeutic areas.
The new facility will be based in the US and will accommodate phase 3 and commercial manufacturing.
A phased approach to construction will initially allow 4 modular suites with each suite including up to two 2000 L bioreactors, followed by the addition of two further 2000L suites. Additionally, 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.
Jonathan Goldman, CEO of Abzena, said: "We are delighted to support our partners and the patients they serve with this investment in cGMP biologics manufacturing. This builds on the successful launch of our second cGMP facility in San Diego in 2020. We are pleased to provide integrated asset development with a full suite of in-house services from discovery through clinical and commercial phases without the need for technology transfer."
Kimball Hall, President and COO of Abzena, added: "The expansion in manufacturing capacity allows us to scale with our expanding customer needs. Our team is very experienced in high quality clinical and commercial manufacturing of mammalian drug substance. We have used this experience to incorporate the most technologically advanced solutions in the design of the new site and are excited to welcome existing and new partners to work with us."