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
Guidebook: Break Down Roadblocks to Clinical Success
The key to this success is to make the right decisions at the right time. In this guidebook, our experts share some key considerations to help biopharmaceutical companies successfully advance a molecule from the laboratory to the clinic as quickly as possible without sacrificing product quality, process efficiency, or patient safety.

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Merck:/Freestyle/DIV-Divisional/Services/biopharm-services/e2e-brochure-cover.jpgBioReliance® End-to-End Solutions 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.

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