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Process Scale Up and Technical Transfer Services

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Tech Transfer Your Existing MAb Production Process

Managing Process Scale-up and Tech Transfer
Presenter: Guillaume Plane, Global Development and Marketing Manager, Biodevelopment Services, Merck

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The goal of technology transfer activities is to transfer product and process knowledge from development and GMP clinical production to GMP commercial manufacturing location.

Technical transfer activities include:
  • Analytical methods validation to test methods robustness prior to process scale up
  • Small scale process validation to test process limits prior to scale up
  • Process scale up to reach the expected production capacity
  • Analytical methods and USP/DSP technical transfer activities including:
    • Tech transfer protocol
    • Associated tests and reports
    • Detailed process description
    • Process risk analysis and training plan for your production technicians and operators
  • Commercial scale process validation for the production and release of DS validation batches at commercial scale in your facility

Make Your Process a Success, Anywhere in the World

When the time comes to scale up your production process, transfer it to a local manufacturing partner for commercial routine production, or move it and build your own facility, our experts will work with you to ease the process and make your program a success.

Transfers need to be performed in an organized, methodical manner with appropriate documentation and within shortest possible timeframe. With you, our local team of experts can develop and execute the process technical transfer plan, ensuring that the overall project will stay within expected timing and lead to a successful outcome.

Our experience implementing and operating a full single use and hybrid GMP processes with our own technologies and products platforms.

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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Guidebook: Break Down Roadblocks to Commercial Success
The decision to build your own cGMP biomanufacturing facility is complex, and must ultimately fit your commercial strategy. Discover our guidebook for today’s biopharma executives seeking to navigate through the important considerations necessary to successfully build their own cGMP biomanufacturing facility: business planning, technology, regulatory/risk assessment and engineering.

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Merck:/Freestyle/media/lp/webinars.jpgWatch our recent webinar, "Process of the Future: Cheaper, Faster and Safer with Single-Use Technologies" to learn how we have overcome transfer challenges and risks by implementing a strategy that utilizes both traditional and new technologies.

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