Abzena Unveils Significant Growth Plans for Its Biologics Production Facility
Abzena, a prominent U.S. contract development and manufacturing organization (CDMO), has announced a significant enhancement of its microbiology quality control (QC) lab at its biologics development and manufacturing facility located in San Diego, California.
This expansion addresses the growing demand for quality testing driven by stricter regulatory frameworks and the rising intricacy of biologics and bioconjugates. By 2023, the global biologics market size approached nearly 0 billion, with projections estimating it to reach approximately 0 billion by 2032. The surge in biologics development is propelled by innovation in targeted therapies and the increasing incidence of chronic diseases.
Quality control plays a vital role in the development and manufacturing of biologics, ensuring the end product’s safety, efficacy, and consistency. Frequent and systematic QC inspections throughout the manufacturing process are essential for regulatory compliance, enabling the identification of any variances or issues in production.
In this backdrop, Abzena’s newly established QC microbiology lab serves as a standalone facility that supports separate product testing while optimizing the production processes for biologics and bioconjugates. This aligns with regulatory prerequisites and industry norms, enhancing scalability and operational efficiency.
“This expansion bolsters our sample integrity in managing microbiological testing capabilities,” Troy Wright, Senior Vice President and Global Head of Quality at Abzena, stated in a recent press release. “We are now better equipped to provide quicker results and improved support for our customer network, thus ensuring quality and compliant products for patients globally.”
As an end-to-end provider of bioconjugate and complex biologics services, Abzena operates research, development, and cGMP facilities both in the U.S. and the UK. This latest development will facilitate additional space for equipment and the incorporation of novel technologies, thereby allowing the partitioning of product microbiological testing, which reduces the risk of cross-contamination.
“The new QC testing laboratory marks a considerable milestone for our San Diego site and enhances Abzena’s global laboratory infrastructure,” remarked Sean O’Brien, Senior Vice President and Site Head in San Diego.
“This expansion significantly improves our capacity to provide top-notch analytical services that enhance testing and report development for our customers. We are eager to collaborate with our clients and partners to push the boundaries of medical knowledge while delivering the highest quality testing services globally.”