Abzena, a partner research organisation (PRO), has announced the opening of a biologics testing laboratory situated in close proximity to the company’s biologics process development and manufacturing hub in San Diego, California. The facility will give 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, the company’s sixth site in a global network, means it 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 utilise technology to ensure valid scale down models, and high quality and high titer viral stocks to ensure no interference of viruses with downstream processes.
Tighter control of timelines will be possible at the facility, the company says, alongside rigorous evaluation of each integrated programme to provide appropriate data, de-risking partners’ programmes 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, said: “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 said “This new facility allows us to give our partners an even greater quality of service to meet their programme goals. We are thrilled to expedite our partners programs through this new investment.”