Ten years of the manufacturing classification system: a review of literature applications and an extension of the framework to continuous manufacture-Reference-Cited by-同舟云学术

Ten years of the manufacturing classification system: a review of literature applications and an extension of the framework to continuous manufacture

Published:2024-05-06 Issue:5 Volume:29 Page:395-414
ISSN:1083-7450
Container-title:Pharmaceutical Development and Technology
language:en
Short-container-title:Pharmaceutical Development and Technology

Author:

Leane Michael¹,Pitt Kendal²,Reynolds Gavin³,Tantuccio Anthony⁴,Moreton Chris⁵,Crean Abina⁶,Kleinebudde Peter⁷,Carlin Brian⁸,Gamble John¹,Gamlen Michael⁹,Stone Elaine¹⁰,Kuentz Martin¹¹,Gururajan Bindhu¹²,Khimyak Yaroslav Z.¹³,Van Snick Bernd¹⁴,Andersen Sune¹⁴,Misic Zdravka¹⁵,Peter Stefanie¹⁶,Sheehan Stephen¹⁷

Affiliation:

1. Drug Product Development, Bristol Myers Squibb, Moreton, UK

2. Leicester School of Pharmacy, De Montfort University, Leicester, UK

3. Oral Product Development, Pharmaceutical Technology & Development, AstraZeneca, Macclesfield, UK

4. Technology Intensification, Hovione LLC, East Windsor, New Jersey, USA

5. FinnBrit Consulting, Waltham, Massachusetts, USA

6. SSPC, the SFI Centre for Pharmaceutical Research, School of Pharmacy, University College Cork, Cork, Ireland

7. Faculty of Mathematics and Natural Sciences, Institute of Pharmaceutics and Biopharmaceutics, Heinrich Heine University Düsseldorf, Düsseldorf, Germany

8. Owner, Carlin Pharma Consulting, Lawrenceville, New Jersey, USA

9. Chief Scientific Officer, Gamlen Tableting Ltd, Heanor, UK

10. Consultant, Stonepharma Ltd. ATIC, Loughborough, UK

11. Institute for Pharma Technology, University of Applied Sciences and Arts Northwestern Switzerland, School of Life Sciences FHNW, Muttenz, Switzerland

12. Pharmaceutical Development, Novartis Pharma AG, Basel, Switzerland

13. School of Pharmacy, University of East Anglia, Norwich Research Park, Norwich, UK

14. Oral Solids Development, Drug Product Development, JnJ Innovative Medicine, Beerse, Belgium

15. Innovation Research and Development, dsm-firmenich, Kaiseraugst, Switzerland

16. Research and Development Division, F. Hoffmann-La Roche AG, Basel, Switzerland

17. External Development and Manufacturing, Alkermes Pharma Ireland Limited, Dublin 4, Ireland

Publisher

Informa UK Limited

Link

https://www.tandfonline.com/doi/pdf/10.1080/10837450.2024.2342953

Reference124 articles.

1. Benefits of Fractal Approaches in Solid Dosage Form Development

2. Loss-in-weight feeding, powder flow and electrostatic evaluation for direct compression hydroxypropyl methylcellulose (HPMC) to support continuous manufacturing

3. Towards a better understanding of dry binder functionality

4. ASTM. 2014. Standard E55, E29648–14 Standard Guide for Application of Continuous Pro- cessing in the Pharmaceutical Industry. West Conshohocken, PA: ASTM International;

5. Streamlining the development of an industrial dry granulation process for an immediate release tablet with systems modelling

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