Clinical to Commercial

Reliable, Predictable Performance

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.

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 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.

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.


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

Lifecycle Management

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.

Work with us

We are committed to achieving quality excellence. We’re transparent in our communications and work collaboratively to progress your programs.

Our team collaborates with you and uses deep scientific and technical know-how to find the best solutions using the right technologies to deliver your program with a constant commitment to quality.

We adapt our approach, shorten the lead times, and develop risk mitigation strategies to ensure your overall success to get vital medicines to patients.