Future supply chains enabled by continuous processing - opportunities and challenges : May 20–21, 2014 continuous manufacturing symposium

This paper examines the opportunities and challenges facing the pharmaceutical industry in moving to a primarily “continuous processing”-based supply chain. The current predominantly “large batch” and centralized manufacturing system designed for the “blockbuster” drug has driven a slow-paced, inventory heavy operating model that is increasingly regarded as inflexible and unsustainable. Indeed, new markets and the rapidly evolving technology landscape will drive more product variety, shorter product life-cycles, and smaller drug volumes, which will exacerbate an already unsustainable economic model. Future supply chains will be required to enhance affordability and availability for patients and healthcare providers alike despite the increased product complexity. In this more challenging supply scenario, we examine the potential for a more pull driven, near real-time demand-based supply chain, utilizing continuous processing where appropriate as a key element of a more “flow-through” operating model. In this discussion paper on future supply chain models underpinned by developments in the continuous manufacture of pharmaceuticals, we have set out; •The significant opportunities to moving to a supply chain flow-through operating model, with substantial opportunities in inventory reduction, lead-time to patient, and radically different product assurance/stability regimes. •Scenarios for decentralized production models producing a greater variety of products with enhanced volume flexibility. •Production, supply, and value chain footprints that are radically different from today's monolithic and centralized batch manufacturing operations. •Clinical trial and drug product development cost savings that support more rapid scale-up and market entry models with early involvement of SC designers within New Product Development. •The major supply chain and industrial transformational challenges that need to be addressed. The paper recognizes that although current batch operational performance in pharma is far from optimal and not necessarily an appropriate end-state benchmark for batch technology, the adoption of continuous supply chain operating models underpinned by continuous production processing, as full or hybrid solutions in selected product supply chains, can support industry transformations to deliver right-first-time quality at substantially lower inventory profiles

Future Supply Chains Enabled by Continuous Processing-Opportunities Challenges May 20-21 2014 Continuous Manufacturing Symposium.

This paper examines the opportunities and challenges facing the pharmaceutical industry in moving to a primarily "continuous processing"-based supply chain. The current predominantly "large batch" and centralized manufacturing system designed for the "blockbuster" drug has driven a slow-paced, inventory heavy operating model that is increasingly regarded as inflexible and unsustainable. Indeed, new markets and the rapidly evolving technology landscape will drive more product variety, shorter product life-cycles, and smaller drug volumes, which will exacerbate an already unsustainable economic model. Future supply chains will be required to enhance affordability and availability for patients and healthcare providers alike despite the increased product complexity. In this more challenging supply scenario, we examine the potential for a more pull driven, near real-time demand-based supply chain, utilizing continuous processing where appropriate as a key element of a more "flow-through" operating model. In this discussion paper on future supply chain models underpinned by developments in the continuous manufacture of pharmaceuticals, we have set out; The paper recognizes that although current batch operational performance in pharma is far from optimal and not necessarily an appropriate end-state benchmark for batch technology, the adoption of continuous supply chain operating models underpinned by continuous production processing, as full or hybrid solutions in selected product supply chains, can support industry transformations to deliver right-first-time quality at substantially lower inventory profiles. © 2015 The Authors. Journal of Pharmaceutical Sciences published by Wiley Periodicals, Inc. and the American Pharmacists Association.The authors would like to acknowledge the following for valuable comments and inputs during the preparation of this white paper; Professor Lee Cronin (Glasgow University, UK), Patricia Hurter (Vertex), Mark Buswell (GSK), and Chris Price (GSK). We would also like to acknowledge the support and funding from the UK's Engineering and Physical Sciences Research Council's (EPSRC) Centre for Innovative Manufacturing in Continuous Manufacturing and Crystallisation (CMAC), and the UK's Department of Business Innovation and Skill's (BIS) Advanced Manufacturing Supply Chain Initiative (AMSCI) funded Project Remedies.This is the final version of the article. It first appeared from Wiley via http://dx.doi.org/10.1002/jps.2434

The influence of aryl-aryl interactions in the photochemistry of some 1,3-Diarylpropanes

The irradiation of 1,3-diarylpropanols in acidic methanol results in their conversion to the corresponding methyl ethers. This reaction and that of the photodechlorination of some 1,3-diarylpropanes is influenced by the presence of electron donating substituents in the aryl group remote from the reactive site

Why we need continuous pharmaceutical manufacturing and how to make it happen : a summary of thoughts from the international symposium on continuous manufacturing

We make the case for why continuous pharmaceutical manufacturing is essential, what the barriers are, and how to overcome them. To overcome them, government action is needed in terms of tax incentives or regulatory incentives that affect time

Collaboration as the Best Medicine

Collaboration can be pivotal in making change happen. So how can new collaborative models be forged in areas where such relationships are not well established, but where change is required? In UK medicines manufacturing, there is an opportunity and a pressing need for progressive change. But there are also plenty of challenges and obstacles, particularly in a highly competitive and tightly regulated sector. A bold step forward has been taken through a collaborative £23m four-year project, ReMediES, involving 22 industry partners and 2 leading UK Universities. Dr Jag Srai and Professor Clive Badman, co-Directors of Project ReMediES discuss how the project has forged a model for change through collaboration.EPSRC, AMSC

Emerging applications and regulatory strategies for advanced medicines manufacturing - Towards the development of a platform approach.

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