Abzena invests $60m into cGMP manufacturing capacity

The facility will enable the company to deliver Phase I to commercial manufacturing services for biologic projects.

The new 50,000 sq. ft ‘Lusk’ facility, at the company’s site in San Diego, CA, USA, houses a process development laboratory and two new cGMP manufacturing cleanrooms for 500 L and 2,000 L scale in Sartorius single-use bioreactors. The facility also houses a GMP warehouse, and analytical development and quality control laboratories.

The new 7,400 sq. ft process development laboratory uses Sartorius single-use technology (SUT) bioreactors from Ambr 250 mL to 2 L, 50 L and 200 L STR bioreactor to screen important process parameters to develop robust scaleable processes and ensure seamless manufacturability.

Until now, the company's other San Diego site has been focused primarily on developing and manufacturing Phase I and II clinical trial materials.

This investment has been driven by both existing customer requirements and by wider market demand. The facility will enable the company to deliver Phase I to commercial manufacturing services for biologic projects.

"This expansion will allow us to provide seamless project integration for our customers as they move into Phase III and ultimately commercial manufacture, " said Matt LeClair, Senior Vice President (SVP) and Site Head of Abzena’s San Diego Operations.

To date the San Diego facility has completed hundreds of projects and has had more than 40 successful audits carried out by key customers. The new facility has also received its manufacturing license from the California Food and Drug Branch (FDB).

The addition of the new facility has also created 125 new positions within the company.