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Solid Phase Synthesis of a Functionalized Bis-Peptide Using "Safety Catch" Methodology
Published on: May 15, 2012
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Process Mass Intensity (PMI): A Holistic Analysis of Current Peptide Manufacturing Processes Informs Sustainability
Ivy Kekessie1, Katarzyna Wegner2, Isamir Martinez3
1Early Discovery Biochemistry - Peptide Therapeutics, Genentech, Inc., A Member of the Roche Group, 1 DNA Way, South San Francisco, California 94080, United States.
The Journal of Organic Chemistry
|March 20, 2024
Summary
Therapeutic peptide manufacturing, primarily using solid-phase peptide synthesis (SPPS), has a high environmental impact with a Process Mass Intensity (PMI) of approximately 13,000. This study assesses PMI for 40 peptide processes, revealing a need for greener synthesis methods.
Area of Science:
- Pharmaceutical Chemistry
- Green Chemistry
- Biotechnology
Background:
- Small molecule drugs dominate FDA approvals, but many targets require alternative therapeutics.
- Peptide-based therapeutics offer biocompatibility and versatility, with recent advances enhancing their attractiveness.
- Current peptide manufacturing relies heavily on solid-phase peptide synthesis (SPPS), raising environmental concerns due to high solvent and reagent use.
Purpose of the Study:
- To assess the environmental impact of synthetic peptide manufacturing by compiling Process Mass Intensity (PMI) metrics.
- To compare the sustainability of peptide synthesis with other drug modalities like small molecules and biopharmaceuticals.
- To identify areas for improvement in peptide manufacturing to reduce its environmental footprint.
Main Methods:
- Collected and analyzed Process Mass Intensity (PMI) data from 40 synthetic peptide manufacturing processes across various development stages.
- Classified PMI assessments according to the development phase of the pharmaceutical products.
- Disaggregated PMI by manufacturing stages: synthesis, purification, and isolation.
Main Results:
- Solid-phase peptide synthesis (SPPS) exhibits a high average PMI of approximately 13,000.
- Peptide synthesis PMI is significantly higher compared to small molecule drugs (median PMI 168-308) and biopharmaceuticals (PMI ≈ 8300).
- This comprehensive assessment represents the most extensive evaluation of synthetic peptide manufacturing's environmental metrics to date.
Conclusions:
- The high PMI associated with current peptide manufacturing methods necessitates the development of more environmentally sustainable processes.
- Peptide therapeutics, while promising, require greener manufacturing strategies to align with sustainability goals.
- Further research and innovation in peptide synthesis technologies are crucial for reducing environmental impact.
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