[Research and Development of Manufacturing of Biologics-the Activities of Manufacturing Association of Biologics]

Yakugaku Zasshi. 2022;142(7):723-729. doi: 10.1248/yakushi.21-00211-1.
[Article in Japanese]

Abstract

The industrial application of mammalian cells can be divided into two categories, where (1) the cells are mediators (i.e., the cell produces a desired product), or (2) the cells themselves are the product. The main application of cell-produced products is in biopharmaceuticals (biologics), and these include therapeutic enzymes, cytokines, antibodies, vaccines, and vectors for gene therapy. Among the 291 biopharmaceuticals launched in Europe and the United States by 2018, the number of products produced using mammalian cells exceeded 60%, with Chinese hamster ovary (CHO) cells being used for 131 products. The production of mammalian cells requires a comprehensive approach, including cell line development, cell culture, culture media, bioreactors, scale-up, separation and purification, process development, quality analysis and control, and research and development related to safety. In this manuscript, the activities of the "Manufacturing Technology Association of Biologics (MAB)" are introduced. MAB is a research organization composed of several companies, organizations, and academics that focuses on advanced manufacturing research for the production of biologics.

Keywords: biologics; eco-system; mammalian cell; manufacturing.

MeSH terms

  • Animals
  • Biological Products*
  • CHO Cells
  • Commerce
  • Cricetinae
  • Cricetulus
  • Research

Substances

  • Biological Products