Clinical Scale Template

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Pre-Clinical Through Phase III Material Production Faster

Accelerate Process Development with a Clinical Scale Template

Developing and implementing a clinical-scale process can be time consuming and complex, requiring specification, sourcing and integration of many components. With BioReliance® ClinicReady template, we can rapidly establish your own capabilities for the production of your pre-clinical, Phase I and Phase II material.

We collaborate with you to rapidly develop, scale and implement a robust single-use, clinical scale process for monoclonal antibodies. The customized process will deliver high purity and yield and move predictably and efficiently from bench, to clinical, and ultimately to large-scale commercial production. We can also assist with tech transfer of the process, whether that is within your own organization or to a sub-contractor.

BioReliance® ClinicReady Production Template for mAbs will provide you with:
  • Configurable Upstream and Downstream single-use production equipment for mAbs adapted to cGMP production of pre-clinical, Phase I, II and III material
  • Complete understanding and knowledge of the performances of our technologies used in the template, guaranteeing process robustness and efficiency
  • Standardized unit operations and operating parameters, standardized buffers, easier tech transfer
  • Adaptable specifications for each project, with integration of competitive products and technologies as required

Featured Resources
Merck:/Freestyle/DIV-Divisional/Services/biopharm-services/e2e-brochure-cover.jpgBioReliance® End-to-End Services Biodevelopment: From Molecule to Commercial Production
Whether you are looking to implement proven solutions while reducing costs and mitigating risk, or looking for a partner who will work with you from Process Development through Facility Design and Construction, we have options that will streamline your process. Read Now
Merck:/Freestyle/DIV-Divisional/Services/biopharm-services/monoclonal-cover.jpgOur recent article, "Process and Facility Design for a Monoclonal Antibody Facility", discusses how today's single-use technologies can add flexibility to a MAb facility.

Read Now