An Optimized Safe Process from Bench to Pilot cGMP Production of API Eptifibatide Using a Multigram-Scale Microwave-Assisted Solid-Phase Peptide Synthesizer-Reference-Cited by-同舟云学术

An Optimized Safe Process from Bench to Pilot cGMP Production of API Eptifibatide Using a Multigram-Scale Microwave-Assisted Solid-Phase Peptide Synthesizer

Published:2021-11-24 Issue:12 Volume:25 Page:2754-2771
ISSN:1083-6160
Container-title:Organic Process Research & Development
language:en
Short-container-title:Org. Process Res. Dev.

Author:

D’Ercole Annunziata¹²³,Pacini Lorenzo¹²³,Sabatino Giuseppina¹²⁴,Zini Matteo³,Nuti Francesca¹²,Ribecai Arianna¹³,Paio Alfredo¹³,Rovero Paolo¹⁴⁵^ORCID,Papini Anna Maria¹²⁴⁶^ORCID

Affiliation:

1. MoD&LS Laboratory, University of Florence, Centre of Competences RISE, Via Madonna del Piano 6, 50019 Sesto Fiorentino, Italy

2. Interdepartmental Research Unit of Peptide and Protein Chemistry and Biology, Department of Chemistry “Ugo Schiff”, University of Florence, Via della Lastruccia 13, 50019 Sesto Fiorentino, Italy

3. F.I.S.- Fabbrica Italiana Sintetici S.p.A., Viale Milano 26, 36075 Montecchio Maggiore, Vicenza, Italy

4. CNR-IC Istituto di Cristallografia, Via Paolo Gaifami 18, 95126 Catania, Italy

5. Interdepartmental Research Unit of Peptide and Protein Chemistry and Biology, Department of Neurosciences, Psychology, Drug Research and Child Health─Section of Pharmaceutical Sciences and Nutraceutics, University of Florence, Via Ugo Schiff 6, 50019 Sesto Fiorentino, Italy

6. PeptLab@UCP Platform of Peptide and Protein Chemistry and Biology, Neuville Campus, CY Cergy Paris Université, 5 mail Gay-Lussac, 95031 Cergy-Pontoise Cedex, France

Funder

Regione Toscana

UniversitÃ degli Studi di Firenze

Fabbrica Italiana Sintetici S.p.A.

Publisher

American Chemical Society (ACS)

Subject

Organic Chemistry,Physical and Theoretical Chemistry

Link

https://pubs.acs.org/doi/pdf/10.1021/acs.oprd.1c00368

Reference42 articles.

1. Peptide Therapeutics Market by Type of Peptide (Small, Medium and Large), Route of Administration (Intravenous, Oral, Subcutaneous, Topical and Others), Key Geographical Regions (North America, Europe, Asia-Pacific and Rest of the World) and Key Therapeutic Area (Metabolic Diseases, Oncological Diseases, Endocrine Diseases, Digestive and Gastrointestinal Diseases and Others): Industry Trends and Global Forecasts; Root Analysis Business Research & Consulting, 2021–2030.

2. Are the European Medicines Agency, US Food and Drug Administration, and Other International Regulators Talking to Each Other?

3. Guidelines from the International Conference on Harmonisation (ICH)

4. Guideline, I. H. T. Impurities in New Drug Substances, ICH Q3A (R2); European Medicines Agency: Geneva, Switzerland, 2006; p 25.

Cited by 6 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Scalable preparation of green C-terminal amidation peptide-synthesis TAGs and the optimized TAG-assisted liquid-phase synthesis of eptifibatide;Sustainable Chemistry and Pharmacy;2024-10

2. Synthesis and optimization of stapled DOCK peptides with improved drug-like properties;Arkivoc;2024-03-10

3. Correction: A zinc–porphyrin–peptide conjugate via “click-chemistry”: synthesis and amyloid-β interaction;New Journal of Chemistry;2024

4. Peptide and peptidomimetic tyrosinase inhibitors;The Enzymes;2024

5. Linker, loading, and reaction scale influence automated glycan assembly;Beilstein Journal of Organic Chemistry;2023-07-06