cGMP Biologics Manufacturing- Abzena

cGMP Biologics Manufacturing

We offer reliable, predictable Clinical to Commercial cGMP biologics manufacturing for a wide range of modalities.

Streamlined drug substance manufacturing.

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.

Lifecycle Management

Biologics Drug Development & 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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Preclinical Analytical Development Support

By using stage-appropriate and fit-for-purpose analytical methods for clinical manufacturing, 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 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 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 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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cGMP Bioconjugate & ADC 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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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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