Biologic Technology Transfer

A seamless solution from start to finish.

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

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Technology transfers and scale-up require a high level of cross-functional integration. Abzena has over 20 years of knowledge and expertise across development, analytical, manufacturing, quality, and regulatory affairs.

We collaborate closely with you to help de-risk the pathway to commercialization, ensure manufacturability, and deliver a quality biologic medicine to the patient.

LabZient™: Rapid Analytical Data

Our Approach

We have a comprehensive risk-based approach to ensure a successful technology transfer by capturing process knowledge and analytics throughout your program and incorporating any regulatory authority feedback leading to successful commercial scale-up.

Our prospective approach ensures the transfer of all essential information and that any plan meets the needs of your program.

Adaptable to your cell line and product, our team of scientific leaders is highly skilled in problem-solving and delivering complex projects within narrow timelines while maintaining effective communication and transparency of data.

Ensuring the continued supply of your products meeting your predefined specifications, we are committed to quality and apply cGMP guidelines for all process steps covered during the technology transfers.

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Your Dedicated Project Team

Your project will have a dedicated team appropriate to its requirements. They work relentlessly to ensure the efficient and responsible delivery of your transfer.

Each team consists of a lead for:

  • Business Development
  • Project Manager
  • Scientific Technical
  • Analytical Method Development
  • Quality Control
  • Process Safety
  • Quality Assurance
  • Regulatory Affairs

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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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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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Let’s move medicine forward - Abzena

Partner 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.

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