Many investigational biological therapeutics are manufactured in public hospitals before their potential industrial transposition. Such specific settings enable the transition from bench to bedside of numerous innovative cell and gene therapies (CGT). However, several factors related to biological therapy manufacturing in public hospitals constitute important bottlenecks in their clinical translation. While point-of-care (POC) preparation of cell-based products is ideal for rapid clinical administration, technical constraints of good manufacturing practices (GMPs) are often challenging to implement and maintain. This chapter discusses various aspects of POC GMP manufacture for somatic cell therapies, based on 10 years of real-world experience in the Lausanne University Hospital in Western Switzerland. Notable areas of focus comprised the technical infrastructure and regulatory aspects of POC manufacture for biological therapeutics, as well as quality maintenance from process and operator standpoints. Overall, this chapter underscores the hurdles in upholding industrial best practices for investigational cell therapy POC manufacture in a public hospital setting.

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Challenges of Biological Therapeutics Manufacture in a Public Hospital Environment

  • Marjorie Flahaut,
  • Alexis Laurent,
  • Lee Ann Applegate

摘要

Many investigational biological therapeutics are manufactured in public hospitals before their potential industrial transposition. Such specific settings enable the transition from bench to bedside of numerous innovative cell and gene therapies (CGT). However, several factors related to biological therapy manufacturing in public hospitals constitute important bottlenecks in their clinical translation. While point-of-care (POC) preparation of cell-based products is ideal for rapid clinical administration, technical constraints of good manufacturing practices (GMPs) are often challenging to implement and maintain. This chapter discusses various aspects of POC GMP manufacture for somatic cell therapies, based on 10 years of real-world experience in the Lausanne University Hospital in Western Switzerland. Notable areas of focus comprised the technical infrastructure and regulatory aspects of POC manufacture for biological therapeutics, as well as quality maintenance from process and operator standpoints. Overall, this chapter underscores the hurdles in upholding industrial best practices for investigational cell therapy POC manufacture in a public hospital setting.