Biologics Process Track Record

Reliable, consistent delivery of your program.

Whether you need assistance developing a new process, or improving existing processes, or preparing to manufacture your product, you will benefit from our in-depth expertise.

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Streamlining your program from early phase development to commercialization, mitigating project risk and producing a quality medicine, Abzena is an industry leader in the development, scaling and manufacture of biologics.

Wherever your molecule is in its development path, we have the agility and capability to support technology transfer, process optimization, and full process development capabilities.

Biologics Process Track Record Capabilities

We have a proven track record of producing a wide range of molecules from the most straightforward to very complex modalities:

  • Hundreds of hybridoma cell lines generated for our partners with our 100%-accurate sequencing platform
  • Hundreds of Cell Line Development projects completed expressing biologics including monoclonal antibodies, antibody fragments, bi-specifics, fusion proteins and vaccines
  • Numerous Research Cell Banks, Master Cell Banks, Working Cell Banks generated
  • A multitude of process development projects executed
  • 100% success rate transferring Process Development projects to Manufacturing
  • Numerous Investigational New Drug and Biologics License Applications supported
  • An established Quality System, meeting US and EU regulatory standards

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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, 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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Let’s move medicine forward - Abzena

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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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