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Innovations for Exceptionally Low-Cost Monoclonal Antibody (mAb) Manufacturing

The Grand Challenges family of initiatives seeks to source and seed innovations and accelerate the development of transformational solutions. The Gates Foundation, in collaboration with LifeArc, a self-funded medical research charity in the UK, is calling on innovators, scientists, engineers, and entrepreneurs- whether they are seasoned experts in biologics or pioneers in related fields- to join us in this Grand Challenge. Together, we can unlock new pathways to reduce costs, enhance production efficiency, and ultimately expand access to life-saving treatments for all.

The Gates Foundation and LifeArc are soliciting proposals to develop proof-of-concept for manufacturing platforms that produce monoclonal antibodies at a final drug substance cost-of-goods of $10 per gram (Option A). The goal is to catalyze and accelerate multiple, diverse, innovative bioprocessing approaches that hold the promise of low cost-of-goods mAbs.

Additionally, the Gates Foundation is interested in hearing from organizations that have already completed proof-of-concept work that could result in cost-of-goods of $10 per gram and may be interested in additional support (Option B).

Objectives of the challenge (both Option A and Option B)

  • Advance innovative and bold ideas that enhance production efficiency and improve overall process economics for mAb production, resulting in a final drug substance cost-of-goods of $10 per gram. This includes, but is not limited to:
      • Alternative hosts to mammalian cell culture
      • Alternative to standard downstream purification methods
      • Reduction in material costs
  • Push the boundaries of current technology by harnessing disruptive innovations, possibly from parallel industries, and identify process improvements to reduce manufacturing costs
  • Rethink existing methods of working such as release testing process and costs, high-quality and affordable raw materials and critical reagents

 

For more information, visit the Global Grants Challenges website by clicking HERE.