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Enhances analytical services for antibodies with rapid microbiology release testing and improved scalability through advanced materials separation.
October 30, 2024
By: Kristin Brooks
Managing Editor, Contract Pharma
Abzena, a CDMO for complex biologics and bioconjugates announced a significant expansion of its quality control (QC) testing capabilities at their San Diego, CA biologics development and cGMP manufacturing site. The new lab space enhances Abzena’s existing analytical services for antibodies with rapid microbiology release testing and improved scalability through advanced materials separation. The new microbiology lab was designed as a standalone space to separate product testing from all other testing being conducted in the microbiological space. This better aligns with industry standards and regulatory requirements and optimizes production capacity by separating high volumes of clinical materials, resulting in yields up to 99%, according to the company. Sean O’Brien, SVP and San Diego Site Head said, “Our new QC testing laboratory is a significant milestone for our San Diego site and a further addition to Abzena’s global laboratory network. This expansion enhances our ability to provide state-of-the art analytical services that continue to drive progress in testing and report development for our customers. We look forward to working with our customers and partners to advance the frontiers of medical knowledge and to provide the highest-quality testing services to people around the world.” The dedicated lab space enables the segregation of product microbiological testing from utility and environmental microbiological testing to minimize the risk of cross-contamination. Its increased size will allow room for additional equipment and technologies as needed, including a BSC and two new incubators.
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