Biopharmaceutical contract development and manufacturing organization (CDMO) Abzena announced an expansion to its microbiology laboratory space that will enhance its quality control (QC) testing laboratory at its GMP biologics development and manufacturing site in San Diego, California.
Abzena's expanded laboratory bolsters the company’s antibody analysis capabilities with rapid microbiology release testing, providing improved scalability through advanced materials separation.
The company’s microbiology testing can be performed on biologics such as antibodies, fusion proteins, bispecifics, and recombinant vaccines, in addition to bioconjugates, and antibody drug conjugate (ADC) drug substances and drug products.
The company has said that the laboratory expansion helps to address the demand for quality testing that adheres to increasingly stringent regulatory requirements. “The expansion creates the necessary space to separate all product testing from environmental testing, which in turn improves our ability to more easily meet the expectations of regulators,” a spokesperson for Abzena told BioProcess Insider.
The spokesperson added that the “new setting enhances our footprint, allowing us to add new capabilities such as microbial ID testing and sterility.”
“It also allows us greater throughput through the QC microbiology lab space. This will eliminate the need to leverage outside contractors, increasing speed in delivering to our customers and their patients.”
Sean O'Brien, SVP and San Diego site head said, "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."
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