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The new facility at the company’s San Diego, CA, site will be for late phase and commercial CGMP manufacturing.
Abzena has invested $60 million into a new, approximately 50,000-ft2 facility at its site in San Diego, CA, for late phase and commercial current good manufacturing practice (CGMP) manufacturing. The new facility houses a process development laboratory and two new CGMP manufacturing cleanrooms for 500-L and 2000-L scale single use bioreactors (Sartorius), the company announced in an Oct. 8, 2020 press release.
The facility also houses a GMP warehouse and analytical development and quality control (QC) laboratories and will enable Abzena to deliver Phase I to commercial manufacturing services for biologic projects. New 7400 ft2 of process development laboratory space uses single-use technology bioreactors ranging from 250-mL to 2-L (Ambr, Sartorius) and from 50 L to 200 L (STR, Sartorius) to screen important process parameters to develop robust scalable processes and ensure seamless manufacturability.
“Until now our other San Diego site has been focused primarily on development and manufacture of Phase I and II clinical trial materials. 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 and site head of Abzena’s San Diego Operations, in a company press release. “This latest investment is testament to our commitment to developing our offering in line with the needs of our current customers and the rest of the market.”