Leading contract provider of integrated discovery, development and manufacturing services for biologics and bioconjugates, Abzena, has invested $60 million into a new facility for late phase and commercial cGMP manufacturing.
The new ~50,000 square foot ‘Lusk’ facility, at the company’s site in San Diego, CA, houses 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 quality control (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,” 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.”
This investment has been driven by both existing customer requirements and by wider market demand for our services. The facility will enable the company to deliver Phase I to commercial manufacturing services for biologic projects.
LeClair added, “At Abzena we’re dedicated to delivering an end-to-end service offering that supports our customers from concept to clinic and beyond. 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. The new facility has also received its manufacturing license from the California Food and Drug Branch (FDB).
The new 7,400 square foot process development laboratory uses Sartorius single-use technology (SUT) bioreactors from Ambr 250mL to 2L, 50L and 200L STR bioreactor to screen important process parameters to develop robust scaleable processes and ensure seamless manufacturability.
The addition of the new facility has also created 125 new positions within the company.
The company’s fully integrated biologic services are mirrored in Abzena’s bioconjugation facility in Bristol, PA, where the team support bioconjugation from Phase I into commercial manufacturing.