🔬 This addition enhances their bioassay services, delivering faster and more reliable data for biopharmaceuticals.
🧪 This significant move supports drug developers in meeting regulatory requirements and optimizing development strategies, ensuring comprehensive support from discovery to market.
Introduction:
Abzena, a Contract Development and Manufacturing Organization (CDMO), has announced an expansion of its analytical capabilities to include Good Manufacturing Practice (GMP) cell-based potency testing. This development, implemented at its facilities in Cambridge, U.K., and San Diego, CA, aims to enhance the company’s bioassay offerings and improve the efficiency and accuracy of biopharmaceutical drug development.
- Abzena has expanded its analytical capabilities to include GMP cell-based potency assays, which are crucial for determining the biological activity of biopharmaceuticals.
- These assays will aid in product release and stability testing, enabling the measurement of the cytotoxicity of antibody-drug conjugates (ADCs).
- The integration of these capabilities allows Abzena to deliver precise data on drug potency essential for regulatory submissions.
- Company leaders emphasize that high-quality data is vital for decision-making in both early-phase and late-phase biopharmaceutical programs.
- Abzena’s expansion reflects its commitment to providing comprehensive support throughout the drug development process, from discovery to commercial delivery.
Conclusion:
Abzena’s addition of GMP cell-based potency testing is a significant milestone that enhances its service offerings, enabling clients to produce high-quality biopharmaceuticals efficiently. This strategic expansion not only meets a critical demand in the biopharmaceutical market but also positions Abzena as a reliable partner in drug development, ultimately aiming to accelerate the availability of novel therapeutic solutions for patients.
