Abzena Cambridge Chemistry Lab - Abzena

cGMP Biologics Clinical Manufacturing

Tailored cGMP clinical manufacturing services for biologics.

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Early-phase clinical testing is a critical milestone in advancing your therapeutic program. Abzena understands the importance of reliable cGMP clinical manufacturing, testing, and certification to support both clinical and preclinical stages. Our integrated biologics and bioconjugation facilities deliver flexible, end-to-end cGMP clinical and preclinical manufacture of biologics, bioconjugates and antibody-drug conjugates (ADCs).

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We have a network of aligned facilities that meet your clinical through commercial manufacturing needs across the lifecycle of your molecule. Abzena also support clinical manufacturing for cell therapies through our network of aligned, state-of-the-art facilities that cover the entire molecule lifecycle – from early process development to commercial supply.

Our technical teams bring over 20 years of experience in process development and optimization, analytics and bioassays. As a trusted CDMO clinical manufacturing organization, Abzena ensures every program meets its clinical and commercial objectives.

Move forwards to POC/NDA faster - Abzena

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

At Abzena, quality and stability are central to every stage of clinical manufacturing. Our Quality organization ensures the delivery of safe, compliant products that meet global regulatory expectations and protect patient safety.

We maintain a comprehensive quality management system that supports every clinical manufacturing facility within our network. This system ensures full alignment with regulatory requirements and cGMP standards.

Beyond compliance, Abzena’s technical and analytical expertise enables us to support a wide range of biologic and cell therapy modalities – from simple constructs to complex, multi-functional molecules.

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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 comprehensive analytical support using industry-leading platforms such as LC-MS (Orbitrap, QTOF, MALDI-TOF, QQQ, and Q), biolayer interferometry, (u)HPLC, CE, iCIEF, and SoloVPE. These tools ensure product integrity, stability, and regulatory compliance across all stages of development.

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cGMP Biologics Clinical Manufacturing FAQs

What is clinical manufacturing?

It is the cGMP production of materials for human clinical trials, ensuring safety, quality, and regulatory compliance from early to late phase.

What is a clinical manufacturing facility?

A clinical manufacturing facility is a cGMP site producing clinical-grade biologics and cell therapies. Abzena’s San Diego facility uses advanced single-use systems and analytics.

How is clinical manufacturing for cell therapies different?

It requires specialized facilities and process controls to preserve cell quality. Abzena supports both biologic and cell therapy programs under one quality system.

What is a CMO clinical manufacturing organization?

A CMO clinical manufacturing organization provides outsourced GMP production. Abzena delivers multiple end-to-end biologics development and manufacturing services including process development, scale-up, and full GMP clinical through commercial manufacturing.

What technologies are used in Abzena’s facility?

Our San Diego site features high-titer processing, perfusion, continuous manufacturing, and 50-2,000 L single-use bioreactors with advanced LC-MS and HPLC analytics.

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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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