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.

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 the insight and experience necessary to develop and optimize parameters that are critical for achieving a quality, cost-effective manufacturing process for your medicine.

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 leading to successful commercial scale-up.

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.

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.

Our purpose-built facilities have primary engineering controls for safety and are managed by expert teams to phase-appropriately develop, scale, and manufacture your highly potent API with reduced timelines, complexity, and risk.

Clinical Manufacturing

Supporting the robust scaling of your project from clinical through to commercial scale.

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 conditions leading to quality, consistency, and right-first time operations. We continually make investments to our infrastructure and technology ensuring we meet your expectations.

Quality Control and 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 marketing applications.

Regulatory Affairs

Ensuring compliance and robust regulatory strategies, we develop tailored phase-appropriate qualification, process characterization and analytical method validation strategies.

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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We adapt our approach to shorten lead times and develop risk mitigation strategies to ensure your overall success in delivering vital medicines to patients safely and quickly.