What development stage are you at? - Abzena

cGMP Biologics Commercial Manufacturing

Providing right first time cGMP manufacturing.

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Accelerate from early phase to market-ready with a partner experienced in biologics manufacturing and commercial biologics manufacturing to support your program at every stage. 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 with biopharmaceutical regulations for cGMP biologic manufacturing and commercial biologics manufacturing operations. Our dedicated technical teams focus on ensuring your program meets both clinical and commercial goals.

We operate a network of aligned facilities that support biologics commercial manufacturing needs across the lifecycle of your molecule.

By de-risking your program, we ensure 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 delivers safe and compliant products to support both clinical and commercial biologics manufacturing programs.

Our Quality organization provides a comprehensive suite of quality services to ensure full compliance with regulatory requirements.

Alongside this expertise, we offer the technologies and analytical capabilities needed to support a wide range of modalities, from straightforward molecules 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 Services

Quality Control & Stability

We accelerate commercial programs through expansive in-house analytical capabilities, technologies, and knowledge supporting successful BLA and marketing applications.

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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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Technology Transfer

We utilize a comprehensive risk-based approach to ensure a successful technology transfer by capturing process knowledge throughout your program and incorporating any regulatory authority feedback ...

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cGMP Biologics Commercial Manufacturing FAQs

What is commercial biologics manufacturing?

Commercial biologics manufacturing involves producing biologic therapies at the scale, quality, and consistency required for global commercial supply.

How does Abzena support commercial biologics manufacturing?

Abzena provides cGMP facilities, advanced single-use systems, and technical expertise to deliver reliable clinical through commercial biologics manufacturing programs.

What technologies are used during commercial-scale production?

Our facility uses high-titer processing, continuous manufacturing, perfusion, and scalable upstream and downstream systems suited for commercial supply.

How does Abzena maintain quality during commercial manufacturing?

Abzena’s Quality organization provides end-to-end oversight to ensure all products meet regulatory standards and commercial release criteria.

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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