Macrophage manufacturing: Protecting function through harvest

Macrophage manufacturing: Protecting function through harvest

Macrophages serve two main roles in industry: as an in vitro test system for detecting pyrogens and as a therapeutic. While their applications differ, their manufacturing depends on the same three requirements: scale adherent surface area without a switch to suspension, put harvest quality and functional integrity ahead of expansion yield, and detach cells gently.

This white paper covers:

  • How adherent growth, post-mitotic biology and harvest sensitivity set platform requirements
  • Why harvest is closer to a functional test than a transfer step
  • How manufacturing variability played out in MATCH01, a phase 2 macrophage therapy trial
  • Functional data from large-scale adherent culture, at two vessel scales
  • Monocyte-derived and iPSC-derived macrophages compared
  • A five-question framework for testing a platform decision early
Categories: White paper
TITLE GreenElephantBiotech Whitepaper Macrophage Scaling V1

Is your process ready for scale-up?

Platform decisions are best tested early, before clinical data, regulatory filings and comparability tests build up around the process. We built this framework from the white paper to sense check your platform decision making.

Answer five questions and use the result as a starting point for reviewing the decision with your process development and CMC team.

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