Case Studies Illustrating a Science and Risk-Based Approach to Ensuring Drug Quality When Using Enzymes in the Manufacture of Active Pharmaceuticals Ingredients for Oral Dosage Form-Reference-Cited by-同舟云学术

Case Studies Illustrating a Science and Risk-Based Approach to Ensuring Drug Quality When Using Enzymes in the Manufacture of Active Pharmaceuticals Ingredients for Oral Dosage Form

Published:2016-02-25 Issue:3 Volume:20 Page:594-601
ISSN:1083-6160
Container-title:Organic Process Research & Development
language:en
Short-container-title:Org. Process Res. Dev.

Author:

Wells Andrew S.¹,Wong John W.,Michels Peter C.²,Entwistle David A.³,Fandrick Keith⁴,Finch Gregory L.,Goswami Animesh⁵,Lee Heewon⁴,Mix Stefan⁶,Moody Thomas S.⁶,Pang Long³,Sato Robert K.³,Turner Nicholas J.⁷,Watson Timothy J.

Affiliation:

1. Charnwood Technical Consulting Ltd., Parklands, 24 Northage Close, Quorn, Leicestershire, LE12 8AT, United Kingdom

2. AMRI Inc., Department of Chemical Development, Fermentation and Biotransformations, 21 Corporate Circle, Albany, New York 12203, United States

3. Codexis Inc., 200 Penobscot Drive, Redwood City, California 94063, United States

4. Boehringer-Ingelheim Pharmaceuticals Inc., Chemical Development, 900 Ridgebury Road, Ridgefield, Connecticut 06877, United States

5. Bristol-Myers Squibb, Research & Development, One Squibb Drive, New Brunswick, New Jersey 08903, United States

6. Almac, Department of Biocatalysis and Isotope Chemistry, 20 Seagoe Industrial Estate, Craigavon BT63 5QD, Northern Ireland United Kingdom

7. School of Chemistry, Manchester Institute of Biotechnology, University of Manchester, 131 Princess Street, Manchester, M1 7DN, United Kingdom

Funder

Seventh Framework Programme

European Federation of Pharmaceutical Industries and Associations

Publisher

American Chemical Society (ACS)

Subject

Organic Chemistry,Physical and Theoretical Chemistry

Link

https://pubs.acs.org/doi/pdf/10.1021/acs.oprd.5b00369

Reference30 articles.

1. Use of Enzymes in the Manufacture of Active Pharmaceutical Ingredients—A Science and Safety-Based Approach To Ensure Patient Safety and Drug Quality

2. Development of Biocatalytic Processes in Japan and Germany: From Research Synergies to Industrial Applications

3. Introduction to Biocatalysis Using Enzymes and Micro-Organisms

4. Biocatalysis in Organic Chemistry and Biotechnology: Past, Present, and Future

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