Abzena, a US-based end-to-end integrated CDMO for complex biologics and bioconjugates, has expanded its quality control (QC) testing capabilities at its San Diego, CA, biologics development and cGMP manufacturing site.
The new laboratory space enhances Abzena’s existing analytical toolkit for antibodies with rapid microbiology release testing and offers customers improved scalability through advanced materials separation.
The expansion of the QC microbiology lab is part of Abzena’s broader strategy to help alleviate and address the market demand for quality testing which has been driven by increased regulatory requirements and provides a future-forward approach to streamlining biopharmaceutical innovations.
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 optimises production capacity by separating high volumes of clinical materials, resulting in yields up to 99%. This design methodology offers superior operational efficiency and improved scalability while minimising overall ecological impact.
The new laboratory space enhances Abzena’s existing analytical toolkit for antibodies with rapid microbiology release testing
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 laboratory space enables the segregation of product microbiological testing from utility and environmental microbiological testing to minimise 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.
Troy Wright, SVP & Global Head of Quality at Abzena, said: "This announcement comes at a very timely moment with World Quality Month quickly approaching. As an organisation focused on quality excellence, increasing our QC footprint is a testament to our commitment to continuous improvement, and innovation. This expansion provides even greater sample integrity in the management of our microbiological testing capabilities. 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."