Abzena, a leading Partner Research Organization (PRO) providing integrated discovery, development and manufacturing of biologics and antibody drug conjugates (ADCs), today announced the opening of a new Biologics Testing Laboratory situated in close proximity to Abzena’s Biologics process development and manufacturing hub in San Diego, California. This brand-new facility will give Abzena’s partners access to cell-based and PCR safety assays; and viral clearance studies to support their IND, IMPD, BLA and MAA applications.
This latest investment, Abzena’s sixth site in a global network, means Abzena now offers both traditional and rapid molecular detection methods; with all services appropriate for research cell banks, characterization of master and working cell banks, end-of-production of cell cultures, and bulk drug substances. Viral clearance studies will utilize technology to ensure valid scale down models, and high quality and high titer viral stocks to ensure no interference of viruses with downstream processes.
The new facility allows for tighter control of timelines alongside rigorous evaluation of each integrated program to provide appropriate biosafety data de-risking our partners programs and supporting their regulatory filings. Bringing these tests into Abzena’s control ensures accelerated timelines for our partners and allows for a single source of data.
Kimball Hall, President and COO, remarked “We are delighted to expand our in-house capabilities to provide those working in the biologics space a rapid, streamlined and de-risked process for their biologics safety testing. Our commitment to patients is unparalleled. By bringing this facility in-house we can ensure that our partners benefit from efficiency ensuring their regulatory goals are met to ultimately get new medicines to patients safely.”
Troy Wright, SVP and Global Head of Quality stated “This new facility allows us to give our partners an even greater quality of service to meet their program goals. We are thrilled to expedite our partners programs through this new investment.”