Abzena, an integrated CDMO and CRO for complex biologics and bioconjugates, has expanded its early and late-phase analytical capabilities to include GMP cell-based potency assays at its Cambridge, UK and San Diego, CA development and manufacturing facilities. The expansion enhances the company’s bioassay offering. 
 
GMP cell-based potency assays play an essential role in quantitatively measuring the biological activity of a biopharmaceutical, and the cytotoxicity of the payload of an Antibody-drug conjugate (ADC), for both GMP product release and stability testing. By adding this capability the company will be able to provide precise and reliable data on drug potency, alongside developability and characterization data including mechanism of action (MOA) and immunogenicity, which are essential for regulatory submissions.  
 
Dr. Campbell Bunce, CSO and Cambridge Site Head at Abzena said, “We recognize that high-quality data is the cornerstone of effective decision-making. When it comes to early-phase biopharmaceutical programs, especially ADCs, developers must have a reliable CRO partner with the deep knowledge and technical capabilities required, and who can deliver the necessary data needed to successfully reach their next target inflection point.” 
 
“Our established expertise and reputation have allowed us to extend our early-phase capabilities to include GMP cell-based potency services at our global sites, addressing a critical need for our customers. This significant milestone further demonstrates our commitment to providing comprehensive, end-to-end support for our customer’s next-generation programs that drive successful outcomes from discovery to the clinic and onwards towards commercial.” 
 
All the Cambridge, UK site’s services are fully integrated with Abzena’s development and manufacturing services at their U.S. facilities in San Diego, CA, and Bristol, PA.