cGMP Biologics Manufacturing- Abzena

End-to-End Clinical Through Commercial cGMP Biologics Manufacturing

We offer reliable, predictable, end-to-end clinical through commercial cGMP biologics manufacturing services for a wide range of modalities including ADCs, AOCs, Bispecifics and more.

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From cell expansion through final high-quality drug substance manufacturing, Abzena is well-equipped to move your biopharma program forward.

You have made a great discovery, developed it, moved it forwards, but now you need to transform it into a drug substance through a reliable process. Abzena offer flexible, predictable Clinical to Commercial cGMP drug substance manufacturing for a range of biologic modalities.

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Developing an efficient, scalable, validated, and cost-effective manufacturing process is essential for success in today’s competitive biologics markets.

Whether you need assistance developing a new process, are improving existing processes, or are preparing to manufacture your product, you will benefit from our in-depth expertise.

Through a comprehensive technology transfer program, we deliver a successful scale-up model to ensure a robust and consistent manufacturing process from clinical to commercial scale.

We collaborate with your team to de-risk the pathway to commercialization, ensure manufacturability, and deliver a quality biologic medicine to the patient.

Technical Excellence in cGMP Biologics Manufacturing Services

Biologics Drug Development & Manufacturing - Abzena

Abzena has established a robust, end-to-end cGMP biologics manufacturing platform in our San Diego, CA facility that is meticulously designed to produce high-quality biologic drug substance for clinical and commercial use. From the initial thaw of a master cell bank (MCB) to the final bulk drug substance, each unit operation is carried out under strict cGMP conditions.

Interested in learning more about our fully integrated development and manufacturing capabilities for biologics? Get in touch with our experts today.

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End-to-End cGMP Biologics Manufacturing Services Support

End-to-End Clinical & Commercial Manufacturing Support for Biologics Info Sheet - Abzena

At Abzena, we’ve continued to invest and build out Clinical & Commercial Manufacturing capabilities for biologics at our dedicated cGMP facility in San Diego, CA. Our facility has been designed to deliver high-quality recombinant proteins and antibodies at scales up to 2000 L, incorporating single-use bioreactors and two standalone production trains to safeguard product quality. By combining our deep scientific expertise, a robust Quality Management System (QMS), and flexible capacity, Abzena provides the integrated support needed to progress seamlessly from clinical batches to full-scale commercial production.

Learn more by downloading our latest info sheet.

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Lifecycle Management

cGMP Biologics Manufacturing- Abzena

To help promote innovation and continuous improvement Abzena has a framework following the ICH guidance ‘Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management’. Working collaboratively alongside you, this will support the management of post approval Chemistry and Manufacturing Control (CMC) changes for your product. We use a scientific and risk-based approach to inform your decision making, ensuring that post approval changes are fit for purpose. Our team are experienced in creating robust data packages that help facilitate regulatory review.

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Abzena’s Platform Process for San Diego

Abzena’s Platform Process for San Diego

By combining a purpose-built cGMP biologics manufacturing facility, single-use disposable platforms, and rigorously validated processes, Abzena delivers a clear, scalable, and compliant pathway from cell bank to bulk drug substance.

Our end-to-end solution is structured to minimize risk, maximize quality, and help you successfully advance your biologic through clinical development and into the commercial market.

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Preclinical Analytical Development Support

By using stage-appropriate and fit-for-purpose analytical methods for clinical manufacturing of biologics, we provide data-driven insights needed to refine and scale processes efficiently – minimizing risk, reducing rework, and positioning programs for future success. Abzena’s GMP biologics manufacturing infrastructure uses validated release and stability methods to support clinical trial material production. Routine testing of critical quality attributes (CQAs) ensures each batch meets stringent regulatory standards throughout clinical development.

Analytical Method Development

Biologics Manufacturing Services

Abzena has extensive experience in cGMP and non-GMP biologics production for recombinant proteins, antibodies and conjugates for preclinical, clinical and commercial materials. We have expertise in employing single-use technology allows for rapid turnaround times and cost-effective solutions. Our state-of-the-art biologics manufacturing facilities located in San Diego, CA, provides world-class cGMP manufacturing.

Process Track Record

We have developed hundreds of mammalian processes, giving us the insight and experience necessary to develop and optimize parameters that are critical for achieving a ...

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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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Master Cell Banking

We offer Master Cell Banking (MCB) services to you by way of expanded and customizable cell-line suites derived from your MCB.

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Process, Production & Qualification (PPQ)

Ensuring your process reliably delivers high-quality, safe products as you scale-up, our experienced scientists and engineers use their extensive knowledge to develop tailored PPQ strategies.

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Clinical Manufacturing

Our specialized, integrated clinical manufacturing services streamline your biologics program's development toward commercialization.

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Commercial Manufacturing

Our integrated network of technical, quality, regulatory, and program management supports the delivery of your cGMP commercial manufacturing program.

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Bioconjugate Clinical Through Commercial cGMP Manufacturing

We are experienced in offering reliable, predictable clinical to commercial cGMP bioconjugates & ADC manufacturing.

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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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cGMP Biologics Manufacturing FAQs

What makes Abzena a leader in end‑to‑end biologics manufacturing?

Abzena offers a fully integrated, end‑to‑end cGMP platform covering everything from master cell bank thaw to final bulk drug substance, ensuring technical rigor, quality, and regulatory compliance throughout development and commercialization. Our San Diego facility supports biologics production up to 2000 L with robust quality systems and parallel manufacturing trains.

What biologic modalities can Abzena manufacture?

Abzena manufactures a wide range of biologics including monoclonal antibodies, recombinant proteins, bispecifics, ADCs, and other complex modalities, supported by scalable, flexible cGMP processes designed for both clinical and commercial supply.

How does Abzena ensure product quality and regulatory compliance?

Abzena’s facilities operate under strict cGMP oversight, supported by an integrated Quality Management System (QMS) covering documentation, deviations, change control, analytical controls, and regulatory support for IND/BLA submissions.

What advantages does Abzena’s single‑use bioreactor technology provide?

Single‑use systems eliminate the need for cleaning validation, minimize cross‑contamination risks, accelerate changeovers, and ensure fast, flexible scaling from pilot to commercial campaigns. Disposable flow paths and purification components further reduce contamination risk.

How does Abzena support scale‑up from clinical to commercial production?

Abzena’s two dedicated production trains enable simultaneous multi‑scale campaigns, allowing smooth progression from early‑stage batches to commercial supply without process disruptions. Their technology transfer framework ensures predictable, validated scale‑up.

What specialized upstream capabilities does Abzena offer?

Upstream workflows include MCB thaw and controlled cell expansion, seed train progression using Wave and stirred‑tank reactors, and fed‑batch production in 500–2000 L bioreactors, all tightly monitored for growth parameters to maximize yield and consistency.

How does Abzena ensure viral safety and high‑purity downstream processing?

Downstream operations include clarification, Protein A capture, low‑pH viral inactivation, AEX/CEX polishing, viral filtration with integrity‑tested filters, and robust UF/DF steps to produce high‑purity, formulation‑ready bulk drug substance.

How does Abzena mitigate cross‑contamination risks in multiproduct facilities?

Abzena operate segregated upstream/downstream suites, use product‑dedicated columns/resins, and implement fully disposable flow paths. Independent cleanroom classifications and biosafety cabinets (ISO 5/7/8) further strengthen segregation.

Let’s move medicine forward.

The leading biologics CDMO + CRO that accelerates drug development, moving medicine forward for patients in need.

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