CALIFORNIA – Abzena, a leading contract provider of integrated discovery, development and manufacturing services for biologics and bioconjugates, has invested US$60 million into a new manufacturing nerve center at its San Diego site, creating 125 additional jobs, the company informed.
“Until now our other San Diego site has been focused primarily on development and manufacture of Phase I and II clinical trial materials,” said Matt LeClair, senior vice president and site head of Abzena’s San Diego operations. “This expansion will allow us to provide seamless project integration for our customers as they move into Phase III and ultimately commercial manufacture.”
The new facility is designated for late phase and commercial current Good Manufacturing Practice (cGMP) manufacturing and also houses a GMP warehouse and analytical development and quality control laboratories.
Moreover, the new 50,000-square-foot facility houses a process development laboratory and two new cGMP manufacturing cleanrooms for 500L and 2,000L scale in Sartorius single use bioreactors.
Data shows 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.
Source: Border Now December 2020 Edition