Abzena Innovates with GMP Cell-Based Potency Testing Services

Abzena Advances Analytical Services with New Capability

Abzena, a prominent integrated Contract Development and Manufacturing Organization (CDMO) and Contract Research Organization (CRO) specializing in complex biologics and bioconjugates, is excited to announce the expansion of its analytical capabilities. This new venture includes the addition of GMP cell-based potency testing at their esteemed facilities. With locations in both the UK and the US, this expansion is set to revolutionize the services provided to clients in drug development.

Enhancing Drug Development with GMP Cell-Based Assays

The introduction of GMP cell-based potency assays is a significant milestone in the realm of biopharmaceuticals. These assays are critical for quantifying the biological activity of biopharmaceutical products. They also assess the cytotoxicity of payloads within Antibody-drug conjugates (ADCs), making them essential for product release and stability testing. By incorporating these advanced capabilities, Abzena will equip its customers with precise and robust data on drug potency, ensuring excellence in drug development and regulatory compliance.

Support for Regulatory Submissions

Understanding the complexities involved in regulatory submissions, Abzena aims to deliver crucial developability and characterization data that includes mechanism of action (MOA) and immunogenicity. This strategic move will not only enhance the quality of data provided but also support biopharmaceutical companies in making informed decisions during the development process.

Commitment to Quality and Expertise

Dr. Campbell Bunce, Chief Scientific Officer and Site Head in the UK, emphasized how critical it is for developers to have trustworthy partners who are well-versed in the nuances of the industry: "Reliable data is the backbone of successful strategies in early-phase biopharmaceutical programs. We are dedicated to providing exceptional analytical support that our clients can count on when reaching vital development milestones."

Building a Comprehensive Support System

Abzena's ongoing dedication to innovation is evident in its substantial investment in technology and talent. Sean O’Brien, Senior Vice President and San Diego Site Head, highlighted the importance of a strong analytical foundation in the drug development process: "We understand how pivotal analytical support is throughout all development phases. Our state-of-the-art toolkit is designed to enhance our clients' capabilities and expedite the journey from discovery to patient availability."

Strategies for Optimizing Drug Development

Through the enhancement of their analytical offerings, Abzena is poised to empower pharmaceutical companies in optimizing their development strategies, streamlining their operations, securing funding, and effectively navigating regulatory pathways. The firm recognizes the urgency of bringing life-changing medicines to market and is committed to driving forward the ambitions of biotech and biopharma innovators.

Integrated Services Across Locations

All services offered at the UK site are fully integrated with Abzena's development and manufacturing operations in the US. This systematic approach ensures that clients benefit from a seamless experience across different geographical locations, facilitating a more cohesive development process.

About Abzena

Abzena acts as a leading partner in the bioconjugate and complex biologics space, providing CDMO and CRO services. The company prides itself on offering integrated programs that address the specific needs of each client, effectively reducing risks in the development of new therapies. With an aim to enhance the potential of every project, Abzena delivers bespoke solutions that propel the progression of medicines from the lab to the market. The company's facilities are strategically located in prominent regions, ensuring access to cutting-edge resources and expertise. Abzena, backed by Welsh, Carson, Anderson & Stowe, represents a strong force in the biopharmaceutical landscape.

Frequently Asked Questions

What are GMP cell-based potency assays?

GMP cell-based potency assays are tests conducted to measure the biological activity and potency of biopharmaceutical products to ensure their effectiveness.

Why are these assays important?

These assays are crucial for quantifying drug potency, ensuring safety, and compliance for product release and stability testing in the biopharmaceutical industry.

How does Abzena support drug developers?

Abzena provides analytical support, integrated services, and expertise to help drug developers navigate the complex process of bringing new drugs to market.

What sets Abzena apart from other CDMOs?

Abzena offers a comprehensive range of integrated services tailored to meet the specific needs of clients, ensuring a streamlined development process and quick access to critical data.

Where does Abzena operate its facilities?

Abzena has research, development, and cGMP facilities located in San Diego, Bristol, and Cambridge, ensuring extensive global support for its client base.

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