Abzena, a CDMO, said it has expanded its early- and late-phase analytical capabilities to now include GMP cell-based potency assays at their Cambridge, U.K., and San Diego, CA, development and manufacturing facilities. The expansion enhances Abzena’s extensive bioassay offering, providing customers with a more comprehensive, streamlined, and cost-effective way to access critical data faster, according to Campbell Bunce, PhD, CSO and Cambridge site head.
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 to their global toolkit, Abzena 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, noted Bunce.
High-quality cornerstone data
“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,” he continued.
“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.”
“Biological drug development requires robust analytical support across all phases of development,” added Sean O’Brien, SVP and San Diego site head. “We’ve placed significant importance on building a state-of-the-art analytical toolkit because we understand the value that it provides to our customers.
“Our goal is to help our customers optimize their drug development strategies, secure funding, and navigate regulatory pathways more effectively. We will continue to invest in our expertise and expand our laboratories so that our broader analytical offering can best support them in their mission to get life-changing medicines to patients.”
All the Cambridge, U.K. 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, pointed out Bunce.
