Process Track RecordTechnology TransferPPQ – Process, Production & QualificationCommercial ManufacturingQuality Control & StabilityRegulatory

Commercial
Manufacturing

Providing Right First Time cGMP Manufacturing

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

We have a network of aligned facilities that meet your manufacturing needs across the lifecycle of your molecule.

By de-risking your program, we ensure that technology transfer from your facility to ours or within our network, is successful and meets all product quality requirements.

Our single use facilities are designed for Biologics manufacturing with the flexibility and scalability to meet your commercial needs.

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Quality is 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

Our modern, single use facilities located in San Diego, CA and Sanford, NC, deploy 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.