cGMP Biologics Clinical Manufacturing

Tailored cGMP clinical and preclinical manufacturing services.

Early-phase clinical testing is a crucial milestone in the development of your product. Abzena understand the importance of cGMP clinical and preclinical manufacturing, testing, and certification. Our services are tailored and designed to meet your individual requirements.

Contact Us

Our integrated biologics and bioconjugation facilities can support cGMP clinical and preclinical manufacture of biologics, bioconjugates and antibody drug conjugates (ADCs). We have a network of aligned facilities that meet your manufacturing needs across the lifecycle of your molecule.

Our dedicated and experienced technical teams are committed to ensuring your program meets its clinical (and commercial) goals. We ensure compliance to biopharmaceutical regulations for cGMP clinical manufacturing operations.

Our biologic manufacturing services are complemented by over 20 years of expertise in process development and optimization, as well as analytics and bioassays.

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

Abzena’s Quality organization provides safe and compliant products to your patients.

Our Quality organization has a comprehensive program of quality services to ensure compliance with regulatory requirements.

In addition to our expertise, we have the technologies and analytical capabilities to handle any of your modalities; from the simple to the most complex.

Our Facilities

San Diego, CA Facility

Our modern, single-use facility located in San Diego, CA, deploys the latest in technology and processing, including high titer processing, continuous manufacturing, and perfusion.

Our upstream facilities include Single Use Bioreactors from 50L to 2000L. Our downstream process capabilities include chromatography ranging up to 80cm columns.

We offer industry-leading analytical capabilities such as LC-MS (Orbitrap, QTOF, MALDITOF, QQQ and Q), biolayer interferometry, (u)HPLC, CE, iCIEF and SoloVPE.

Let’s move medicine forward.

The asset you’re developing right now can make a real difference for human health. Let us apply our wealth of experience to accelerate and maximize its potential.