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.

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

Lifecycle Management

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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Bioconjugates & ADCs Manufacturing Services

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

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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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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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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