What development stage are you at? - Abzena

cGMP Biologics Commercial Manufacturing

Providing right first time cGMP manufacturing.

Accelerate seamlessly from early phase to market-ready with a partner who has the biologics manufacturing experience to support your program every step of the way. Abzena's single use facility is designed for biologics manufacturing with the flexibility and scalability to meet your commercial needs.

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We ensure compliance to biopharmaceutical regulations for cGMP biologic manufacturing 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.

EpiScreen® 2.0: Smarter Immunogenicity Testing - Abzena

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.

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Our Facilities

Abzena San Diego

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.

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Related Content

Quality Control & Stability

Accelerating your path, we develop, execute and document phase appropriate methods necessary to produce high-quality, well-characterized material and the data to support successful BLA and ...

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Regulatory Affairs

Ensuring compliance and robust regulatory strategies, we develop tailored phase-appropriate qualification, process characterization and analytical method validation strategies.

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Let’s move medicine forward - Abzena

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.

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