The approximately 50,000 sqft ‘Lusk’ facility, at the company’s site in San Diego, CA, US, houses a process development laboratory and two 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 (QC) laboratories.
Matt LeClair, Senior Vice President (SVP) and Site Head of Abzena’s San Diego Operations said: “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.
The facility will enable the company to deliver Phase I to commercial manufacturing services for biologic projects.
LeClair said: “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 facility has also received its manufacturing license from the California Food and Drug Branch (FDB).
The 7,400 sqft 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 scaleable processes and ensure manufacturability.
The completion of the facility has also created 125 positions within the company.
The company’s integrated biologic services are mirrored in Abzena’s bioconjugation facility in Bristol Pennsylvania where the team support bioconjugation from Phase I into commercial manufacturing.