CDMO Abzena reports that it has invested $60m into a new facility for late phase and commercial cGMP manufacturing. The new ~50,000 sq ft Lusk Blvd. facility at the company’s site in San Diego features a process development laboratory and two new cGMP manufacturing cleanrooms for 500L and 2,000L scale in Sartorius single use bioreactors. The facility also houses a GMP warehouse, and analytical development and QC laboratories.
“Until now our other San Diego site has been focused primarily on development and manufacture of Phase I and II clinical trial materials,” says Matt LeClair, senior vp 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.”
According to LeClair, the investment has been driven by both existing customer requirements and by wider market demand for its services. The facility will enable the company to deliver Phase I to commercial manufacturing services for biologic projects.
“At Abzena we’re dedicated to delivering an end-to-end service offering that supports our customers from concept to clinic and beyond,” continues LeClair. “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.”
To date the San Diego facility has completed hundreds of projects and has had more than 40 successful audits carried out by key customers, he points out. The new facility has also received its manufacturing license from the California Food and Drug Branch (FDB).
The new 7,400 sq ft process development lab uses Sartorius single-use technology bioreactors—Ambr® 250mL to 2L, 50L and a 200L STR bioreactor to screen process parameters to develop saleable processes.
The company’s fully integrated biologic services are mirrored in Abzena’s bioconjugation facility in Bristol, PA where the team supports bioconjugation from Phase I into commercial manufacturing.