• Introduction: The Bill & Melinda Gates Foundation, in partnership with LifeArc, is launching the "Innovations for Exceptionally Low-Cost Monoclonal Antibody (mAb) Manufacturing" challenge. The aim is to reduce the cost of monoclonal antibody (mAb) production to $10 per gram, making them more accessible in low- and middle-income countries. This challenge is dedicated to the memory of Dr. Steve Hadley, a former senior program officer at the Gates Foundation who advocated for cost reduction in mAb production.

• General Description of the Call: The challenge seeks innovators, scientists, engineers, and entrepreneurs to submit solutions that improve production efficiency and lower the manufacturing costs of mAbs. Proposals can address the following areas:

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  Use of alternative hosts to mammalian cell culture.

  Innovative purification methods.

  Cost reductions in materials.

  Application of technologies from other industries.

  <!-- data-end="1250"-->The goal is to explore bold ideas that offer clear pathways to achieve the $10 per gram target.

• Objectives:

  • To improve production efficiency and reduce costs in the mAb manufacturing process.

  • To explore disruptive innovations and interdisciplinary collaborations.

  • To rethink existing methods for lowering costs while improving quality.

• Eligibility:

  • Open to non-profit organizations, for-profit companies, international organizations, government agencies, and academic institutions.

  • Proposals led by women or collaborations with women-led organizations are encouraged, as well as applications from institutions in low- and middle-income countries.

  • Only individuals applying through a legally recognized entity are eligible.

• Specific Criteria:

• Proposals should aim to produce mAbs at volumes of at least one metric ton per year.

• Solutions must reduce costs without relying on existing shared or dedicated facilities.

• Teams should have demonstrated capacity and plans to generate data within 12 months.

• Justified cost breakdowns, subject to external evaluation, are required.

• Solutions must be applicable to manufacturing in low- and middle-income countries.

• For Option B, present data demonstrating technical readiness levels 3-5 for producing mAbs at $10 per gram.

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