Bioconjugates, ADCs & Chemistry CRO+CDMO - Abzena

Quality Excellence

We are committed to the quality of everything we do to move medicine forward. At Abzena, Quality is culture.

Quality excellence is first – to patients, regulatory authorities, and our partners.

Abzena’s ‘Quality Organization’ was formed to provide safe and compliant products to your patients. Quality is more than a requirement; it is the foundation upon which we build life-changing therapies for our customers.

Through all phases of the drug development journey, we adhere to the highest standards. This ensures product quality, safety and efficacy. Our customers, healthcare providers, and regulatory bodies trust us to maintain excellence at every stage of development.

Our ‘Quality Organization’ utilizes a comprehensive program of quality services. Through these, we can ensure compliance with regulatory requirements and proactively solve problems to ensure downstream success.

Our Commitment to Quality

Our commitment and focus on ‘Quality’ is founded in our values. These values allow us to be creative and innovative in everything we do for our customers’ success.

When you partner with us we work to ensure consistently high standards of quality across all of the stages of the drug development process. Here is what you can come to expect when you partner with Abzena:

Access to Genuine Scientific & Technical Experts
Proactive Solutions for Streamlining Development
Diverse and Interconnected Teams
End-to-End Support Under One Organization

Expansion of Quality Control (QC) Testing Capabilities

Abzena San Diego, CA

In October 2024, we expanded our quality control (QC) testing capabilities at our San Diego, CA biologics development and cGMP manufacturing site. Our new laboratory space enhances Abzena’s existing analytical toolkit for antibodies with rapid microbiology release testing and offers our customers improved scalability through advanced materials separation.

Innovative Platform Solutions

In addition to our commitment of quality and excellence, we have developed the platform technology solutions and analytical capabilities to handle any of your biologic modalities; from the simple to the most complex including antibody-drug-conjugates (ADCs). In developing biologics such as monoclonal antibodies (mAbs) and recombinant proteins, we implement stringent quality controls from the outset. Our cell line development platform, AbZelectPRO™, utilizes high-throughput screening to select robust and stable candidates. We focus on critical quality attributes early, this lays the robust foundation for successful therapeutic development.

Regulatory Support and Compliance

Bioconjugate & ADC Formulation Development - Abzena

Successfully navigating regulatory affairs necessitates specialized knowledge and strategic insight. Here you benefit from over 20 years of experience in our scientific team who works in close partnership with customers to incorporate quality considerations into their strategic planning. Abzena provide support in the preparation of detailed documentation for regulatory submissions, guaranteeing clarity. By aligning our quality practices with regulatory expectations, we facilitate a streamlined review processes.

“Throughout the development of AGX101, Abzena has worked closely with us to achieve successful GMP manufacturing and quality control. We could not have reached this milestone without Abzena’s expertise, cooperation, and support.”


Paul Jaminet

Paul Jaminet | Co-founder & CEO
Angiex

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"I’ve never had a CRO project go this smoothly and the ADCs delivered were very high quality. I’m confident that my client will put Abzena at the top of their list for future ADC projects."



David Jackson

David Jackson | Pharmaceutical Consultant & ADC Expert
DYJ Pharma Consulting

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"Abzena has been crucial in advancing and validating our technology and programs. The team is very thoughtful, has strong troubleshooting skills and maintains a high standard in generating quality data with integrity. We highly recommend working with Abzena."

Shiva Bhowmik, PhD

Shiva Bhowmik, PhD | COO
TRIO Pharmaceuticals, Inc.

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"We worked with the Abzena team for the design and the initial production of both the mAb and the antibody-chelator conjugate to support our R&D programs. We had a productive and valuable interaction with a highly skilled scientific team and we benefited from the flexibility of the services at this early stage of development."
Tina Bjørnlund Bønsdorff

Tina Bjørnlund Bønsdorff | CSO
Oncoinvent AS

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Let’s move medicine forward - Abzena

Let's move medicine forward

We enable you to bring life-changing medicines to patients in need faster. Let’s talk and move medicine forward.