Process Track RecordTechnology TransferPPQ – Process Performance & QualificationCommercial ManufacturingQuality Control and StabilityRegulatory

Process Track
Record

Reliable, consistent delivery for your program

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 small molecule intermediates including high potency chemistry, payloads, linkers, payload-linker chemical intermediates, bioconjugation and Antibody Drug Conjugates (ADCs).

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

 

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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Proven Track Record

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

  • Hundreds 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
  • Thousands of different combinations of linkers, payloads and bioconjugation modalities

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.