- Abzena expands its analytical capabilities to include GMP cell-based potency assays at its Cambridge, UK and San Diego, CA facilities.
- The new capability enhances Abzena’s bioassay services, enabling faster and more reliable data on drug potency, which is essential for regulatory submissions.
Abzena, an integrated contract development and manufacturing organization (CDMO) for biologics, has announced an expansion of its analytical capabilities. The company will now offer GMP cell-based potency assays at its development and manufacturing sites in Cambridge, UK, and San Diego, CA. This expansion is set to streamline the bioassay process for customers, providing a more comprehensive and cost-effective way to obtain critical data.
The newly added GMP cell-based potency assays will allow Abzena to offer precise and reliable data on the biological activity of biopharmaceuticals, including antibody-drug conjugates (ADCs). These assays are crucial for both GMP product release and stability testing, helping to measure cytotoxicity and the potency of drug payloads. The addition of this capability strengthens Abzena’s bioanalytical offerings, which also include mechanism of action (MOA) and immunogenicity assessments for regulatory submissions.
Dr. Campbell Bunce, CSO and Cambridge Site Head at Abzena, emphasized the importance of high-quality data in the early phases of drug development, especially for ADCs. He explained, “Developers must have a reliable CRO partner with deep technical capabilities to successfully reach their next inflection point.”
The expanded service offering is fully integrated with Abzena’s existing development and manufacturing operations at their sites in the US, including San Diego, CA, and Bristol, PA. This integration enables the company to provide a more seamless and efficient service for its clients, addressing critical needs in the development of next-generation biopharmaceuticals.
Sean O’Brien, SVP and San Diego Site Head, added that the company’s continued investment in robust analytical support across all phases of drug development ensures that customers can optimise their drug development strategies and better navigate regulatory pathways.
This development highlights Abzena’s commitment to providing end-to-end support for biopharmaceutical programs, from discovery to clinical and commercial stages. By expanding its analytical capabilities, Abzena aims to enhance its reputation as a trusted partner in the biologics and ADC development sectors.
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