Biologics Drug Development & Manufacturing - Abzena

Bioconjugate & ADC Manufacturing

Reliable, predictable Clinical to Commercial cGMP bioconjugates & ADC manufacturing.

Let's de-risk the pathway to commercialization.

Developing an efficient, scalable, validated, cost-effective bioconjugate and ADC manufacturing process is essential for success in today’s competitive markets. Whether you need assistance developing a new process, are improving existing processes, or are preparing to manufacture your bioconjugate product, you will benefit from Abzena's in-depth expertise.

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

Abzena provides the specialized analytical method support you need, and the technical rigor necessary, for high-quality therapeutics that meet evolving regulatory expectations. Throughout every phase of development and manufacturing, our analytical methods inform critical decisions that de-risk your program.

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

Lifecycle Management

Abzena Bristol

Promoting innovation and continuous improvement we adhere to a framework following ICH guidance and work collaboratively alongside you, to support the management of post approval Chemistry and Manufacturing Control (CMC) changes for your product.

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Preclinical Analytical Development Support

Bioconjugate & ADC Formulation Development - Abzena

Analytical methods are essential to toxicological batch manufacturing, clinical manufacturing, release and stability. Specialized analytical methods monitor product integrity and stability, providing reliable data that informs early-stage development decisions and mitigates risk prior to clinical trials. 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

Bioconjugate & ADC Manufacturing Services

Abzena has extensive capabilities in cGMP and non-GMP bioconjugate production. We have expertise in employing single-use technology that allows for rapid turnaround times and cost-effective solutions.

Antibody-Drug Conjugate (ADC) Manufacturing

We offer integrated development and manufacturing services across the ADC components: antibodies, linker payloads, and bioconjugation.

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Clinical Manufacturing

Our integrated network of technical, quality, regulatory, and program management supports the delivery of your commercial manufacturing program. We offer reliable, predictable performance under cGMP ...

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Commercial Manufacturing

Our integrated network of technical, quality, regulatory, and program management supports the delivery of your commercial manufacturing program. We offer reliable, predictable performance under cGMP ...

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Process Track Record

We have developed hundreds of small molecules including high potency chemistry, payloads, linkers, payload-linkers as well as bioconjugation and Antibody Drug Conjugates (ADCs), giving us ...

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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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Process Performance & 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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Highly Potent Materials

Utilizing a combination of technology, infrastructure, and expertise, we provide you with seamless, flexible highly potent API development and manufacturing tailored to your specific needs.

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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.

Supporting the robust scaling of your project from clinical through to commercial scale, we are dedicated to manufacturing excellence, delivering small molecule intermediates including bioconjugates and antibody-drug conjugates (ADCs).

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