Why Abzena?
Our focused approach.
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 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
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.
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.
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.
We enable you to bring life-changing medicines to patients in need faster. Let’s talk and move medicine forward.