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Cell-free Production of Pharmaceutical-grade Biologics

Completed TRL 2 (started at 1, targeting 2)

Description

Industry Project

Biomolecules, such as proteins, carbohydrates, and metabolites, hold promise as treatments and diagnostic markers for a wide variety of diseases, including cancer, diabetes, and Alzheimer’s disease. However, generating the appropriate biomolecules currently requires numerous chemicals and cell-culture systems. Synlife Inc. proposes developing freeze-dried, cell-free extracts that can generate active biomolecules upon adding only water and DNA. Further, the kit would allow purification of these biomolecules to a level safe for human injection. This system will be low cost, highly portable, and have a long shelf life.

Benefits

We have shown that production of erythropoietin (EPO), granulocyte-colony-stimulating factor (G-CSF), and granulocyte macrophage colony stimulating factor (GM-CSF), three proteins that could act as treatments for acute radiation poisoning in space, could in theory be produced from freeze-dried cell-free extracts on demand. Adiga et al. (2018) showed similar results with different freeze-dried cell-free extracts and performed both the reaction and purification in automated, custom-built hardware. These proofs-of-concept show that production and purification of therapeutic proteins is possible and can be made practical through advances in method, formulation, and integrated hardware.

Reference:

Adiga R, Al-Adhami M, Andar A, et al. Point-of-care production of therapeutic proteins of good-manufacturing-practice quality. Nat Biomed Eng. 2018;2(9):675-686. https://doi.org/10.1038/s41551-018-0259-1

Details

Technology areaHuman Health, Life Support, and Habitation Systems > Human Health and Performance > Food Production, Processing, and Preservation
ProgramHuman Research Program (HRP)
Lead organizationTranslational Research Institute for Space Health, Houston, TX
Start date2019-05-01
End date2020-04-30

Project contacts

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How to get involved

This is early/mid-stage (TRL 2) — the most realistic path in is NASA SBIR/STTR, which funds small businesses and research institutions to develop technology aligned with NASA's needs (equity-free, phased funding). Check whether a current SBIR/STTR solicitation topic overlaps with this project's technology area, or contact the project directly (above) to ask.

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