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1 results

  • 7 - Manufacturing

  • Shreefal S. Mehta
  • Book:
    Commercializing Successful Biomedical Technologies
    Published online:
    03 November 2022
    Print publication:
    17 November 2022, pp 309-362

  • Summary

    Preparing for scale-up in commercial manufacturing is far away from the thoughts of companies involved in product development, but this chapter shows when to start planning and how to plan a practical budget for this activity. For companies with their first product in commercial development, the build vs buy decision is never an easy one and the examples and key points for consideration simplify that process. The biggest challenge in scaling up is the gap in culture between R&D production for experimental testing in preclinical stages and the control and quality oriented culture in the manufacturing location. The case studies and content in the chapter specifically highlight how to achieve a successful technology transfer into commercial GMP manufacturing. The chapter content also gives practical guidelines on what it takes to put GMP and quality systems in place.