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Emerging Applications and Regulatory Strategies for Advanced Medicines Manufacturing - Towards the Development of a Platform Approach.

Accepted version
Peer-reviewed

Type

Article

Change log

Authors

Badman, Clive 
Bresciani, Massimo 
Cooney, Charles L 

Abstract

The last decade has seen Advanced Medicines Manufacturing (AMM) progress from isolated product developments to the creation of industry-academic centres of excellence, regulatory innovation progressing leading to new standards, and product commercialisation across multiple product formats. This paper examines these developments focusing on successful applications and strategies presented at the 2023 Symposium of the International Consortium for Advanced Medicines Manufacturing (ICAMM). Despite these exemplar applications, there remain significant challenges to the sector-wide adoption of AMM technologies. Drawing on Symposium delegate expert responses to open-ended questions, our coding-based thematic analysis suggest three primary enablers drive successful adoption of AMM technologies at scale, namely: the ability to leverage pre-competitive collaborations to challenge-based problem solving; information and knowledge sharing through centres of excellence; and the development of AMM specific regulatory standards. Further analysis of expert responses identified the emergence of a 'Platform creation' approach to AMM innovation; characterised by: i) New collaboration modes; ii) Exploration of common product-process platforms for new dosage forms and therapy areas; iii) Development of modular equipment assets that enable scale-out, and offer more decentralized or distributed manufacturing models; iv) Standards based on product-process platform archetypes; v) Implementation strategies where platform-thinking and AMM technologies can significantly reduce timelines between discovery, approval and GMP readiness. We provide a definition of the Platform creation concept for AMM and discuss the requirements for its systematic development.

Description

Keywords

Advanced medicines manufacturing, Continuous processing, Platform, Supply chain, Humans, Drug Industry, Pharmaceutical Preparations, Technology, Pharmaceutical

Journal Title

J Pharm Sci

Conference Name

Journal ISSN

0022-3549
1520-6017

Volume Title

Publisher

Elsevier BV
Sponsorship
Engineering and Physical Sciences Research Council (EP/P006965/1)
EPSRC (EP/T517847/1)
Engineering and Physical Sciences Research Council (EP/I033459/1)
EPSRC (via University of Strathclyde) (EP/V062077/1)