Process Mass Intensity (PMI): A Holistic Analysis of Current Peptide Manufacturing Processes Informs Sustainability in Peptide Synthesis

Author:

Kekessie Ivy1ORCID,Wegner Katarzyna2,Martinez Isamir3,Kopach Michael E.4ORCID,White Timothy D.4,Tom Janine K.5ORCID,Kenworthy Martin N.6,Gallou Fabrice7ORCID,Lopez John7ORCID,Koenig Stefan G.8ORCID,Payne Philippa R.9,Eissler Stefan10,Arumugam Balasubramanian11,Li Changfeng11,Mukherjee Subha12ORCID,Isidro-Llobet Albert13ORCID,Ludemann-Hombourger Olivier14,Richardson Paul15ORCID,Kittelmann Jörg16,Sejer Pedersen Daniel17ORCID,van den Bos Leendert J.18

Affiliation:

1. Early Discovery Biochemistry - Peptide Therapeutics, Genentech, Inc., A Member of the Roche Group, 1 DNA Way, South San Francisco, California 94080, United States

2. Active Pharmaceutical Ingredient Development, Ipsen Manufacturing Ireland Ltd., Blanchardstown Industrial Park, Dublin 15, Ireland

3. Green Chemistry Institute, American Chemical Society, 1155 16th St North West, Washington, District of Columbia, 20036, United States

4. Synthetic Molecule Design and Development, Eli Lilly and Company, Indianapolis, Indiana 46285, United States

5. Drug Substance Technologies, Amgen, Inc., 1 Amgen Center Drive, Thousand Oaks, California 91320, United States

6. Chemical Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, Macclesfield, SK10 2NA, United Kingdom

7. Chemical & Analytical Development, Novartis Pharma AG, 4056 Basel, Switzerland

8. Small Molecule Pharmaceutical Sciences, Genentech, Inc., A Member of the Roche Group, 1 DNA Way, South San Francisco, California 94080, United States

9. Outsourced Manufacturing, Pharmaceutical Development & Manufacturing, Gilead Alberta ULC, 1021 Hayter Rd NW, Edmonton, T6S 1A1, Canada

10. Bachem AG, Hauptstrasse 144, 4416 Bubendorf, Switzerland

11. Chemical Macromolecule Division, Asymchem Life Science (Tianjin) Co., Ltd., 71 Seventh Avenue, TEDA Tianjin 300457, China

12. Chemical Process Development, Bristol Myers Squibb, New Brunswick, New Jersey 08903, United States

13. GSK, Gunnels Wood Road, Stevenage, Hertfordshire SG1 2NY, U.K.

14. PolyPeptide Laboratories France SAS, 7 Rue de Boulogne, 67100 Strasbourg, France

15. Chemistry, Pfizer, 10578 Science Center Drive (CB6), San Diego, California 09121, United States

16. CMC API Development, Novo Allé, 2880 Bagsværd, Denmark

17. Chemical Development, Novo Allé, CMC API Development, 2880 Bagsværd, Denmark

18. EnzyTag B.V, Daelderweg 9, 6361HK, Nuth, Netherlands

Funder

American Chemical Society Green Chemistry Institute Pharmaceutical Roundtable

Publisher

American Chemical Society (ACS)

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