Abzena Launches GMP Cell-Based Potency Testing in US and UK Sites, Boosting Analytical Capabilities

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On Nov. 19, 2024, Abzena announced that it will now include good manufacturing practice (GMP) cell-based potency assays at its development and manufacturing facilities in Cambridge, UK, and San Diego, Calif. The addition of these services expands the company’s early and late phase analytical capabilities and enhances its bioassay offering. The expanded capabilities offer more comprehensive, streamlined, and cost-effective ways to access critical data faster (1).

GMP cell-based potency assays play a critical role in the quantitative measurement of biological activity of a biopharmaceutical. These assays are also necessary for assessing the payload cytotoxicity of an antibody-drug conjugate (ADC) (2) for both GMP product release and stability testing. Adding this capability to its toolkit gives Abzena the ability to provide precise and reliable data on drug potency as well as developability and characterization data to elucidate mechanism of action (MOA) and immunogenicity, both essential for regulatory submissions.

“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 [contract research organization] 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,” said Campbell Bunce, PhD, chief scientific officer and Cambridge site head at Abzena, in the press release. “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 services at the company’s Cambridge site are fully integrated with its development and manufacturing services in its US facilities located in San Diego, Calif., and Bristol, Pa.

“Biological drug development requires robust analytical support across all phases of development. At Abzena, 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,” said Sean O’Brien, senior vice-president and San Diego site head at Abzena, in the release. “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.”

References

1. Abzena. Abzena Expands Analytical Capabilities to Include GMP Cell-Based Potency Testing Across US & UK Sites. Press Release. Nov. 19, 2024.
2. Wang, Z.; Li, H.; Gou, L.; Li, W.; Wang, Y. Antibody–Drug Conjugates: Recent Advances in Payloads. Acta Pharm. Sin. B 2023, 13 (10), 4025–4059. DOI: 10.1016/j.apsb.2023.06.015

Source: Abzena