Abzena announces major expansion of its biologics manufacturing facility
The U.S. contract development and manufacturing organization (CDMO) Abzena announced yesterday that it has significantly expanded its quality control (QC) microbiology lab at its biologics development and manufacturing site in San Diego, California.
The expansion comes as the demand for quality testing grows steadily, driven by stricter regulatory requirements and the increasing complexity of biologics and bioconjugates. In 2023, the global biologics market size reached a value of almost $350 billion and is estimated to reach approximately $700 billion by 2032. Driven by innovation in targeted therapies and the rising prevalence of chronic diseases, the development of biologics has become essential in the biopharma industry.
A critical step in biologics development and manufacturing is QC, which is essential to ensure the efficacy, safety, and consistency of the end product. Regular and continuous QC inspections during the manufacturing process test for regulatory compliance and can detect changes or defects in the manufacturing process.
In this context, Abzena’s new QC microbiology lab is a standalone space that allows for separate product testing and optimized production processes of biologics and bioconjugates, aligning with regulatory requirements and industry standards, and improved scalability and operational efficacy.
"[...] This expansion provides even greater sample integrity in the management of our microbiological testing capabilities,” said Troy Wright, SVP & Global Head of Quality at Abzena in a press release. “We are now positioned to deliver faster results and better support for our customer network, ultimately providing quality and compliant products to patients around the world."
As an end-to-end bioconjugate and complex biologics CDMO and contract research organization (CRO), Abzena has research, development, and cGMP facilities across the U.S. and in the UK. This latest expansion allows more room for equipment and novel technologies, and enables the segregation of product microbiological testing, minimizing the risk of cross-contamination.
"Our new QC testing laboratory is a significant milestone for our San Diego site and a further addition to Abzena's global laboratory network,” added Sean O’Brien, SVP and San Diego Site Head, in a press statement.
“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.”
