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.

Leveraging Automation and Data-driven Logistics for Sustainable Farming of High-value Crops in Emerging Economies.

Technology innovations present an opportunity for the agricultural sector to leverage in-field data and inform resource-demanding operations to ultimately promote Sustainable Development Goals (SDGs). The need for data-driven innovations in farming is particularly pertinent to resource-scarce regions, such as the Indian Punjab, where an amalgam of obscure policies and lack of real-time visibility of crops typically leads to the excessive use of farming inputs like freshwater. To this end, this research investigates the use of Internet of Things (IoT) implementations to cultivate Kinnow (a high-value citrus fruit) for assessing the impact of data-informed irrigation practices on the appropriation of natural sources, farming operations efficiency, and the well-being of smallholder farmers. First, a literature taxonomy demonstrates that studies on agri-field logistics often do not consider operations' environmental and energy impact. In addition, the application of IoT and automated guided vehicles (AGVs) for informing farmers about precision irrigation planning has not been sufficiently explored. Second, an empirical-driven numerical investigation explores four alternative irrigation scenarios for cultivating Kinnow, namely: (i) flood irrigation; (ii) manual irrigation; (iii) AGV-informed manual irrigation; and (iv) AGV-assisted irrigation, which was cast as a Capacitated Vehicle Routing Problem. The analysis results compare the overall sustainability impact of the investigated practices on the water-energy nexus. This research is innovative as it focuses on data-driven logistics operations on the environmental, energy and farmers' well-being impact associated with irrigation practices in agronomy. This study further supports the role of data-driven technology innovations towards the transition to SDG-centric food supply chains by providing guiding principles for community-led in-field logistics planning.

Interplay between Competing and Coexisting Policy Regimens within Supply Chain Configurations.

Competing and coexisting policies (CACPs) may arise from the incompatibility of incentives, standards, and regulatory models between a local state and a federal government, or between two government jurisdictions across which supply networks operate. Traditional studies of supply chain dynamics typically explore the impact of policy regimens as standalone instruments. This study explores how the interplay between CACP regimens can affect the supply dynamics between producers, customers, and their intermediaries. We use a supply network configuration lens to assess implications for supply chain actors and system-level outcomes. Our work is motivated by the federal-state dissonance in the current dispute between India's farmers and the federal government regarding new laws that impact agricultural supply chains in India. In this case, alternative and coexisting policy interventions, ostensibly aimed at modernizing and transforming production and distribution, can lead to significant supply chain netting and inventory pooling reconfigurations in terms of material, information, and financial flows among Indian agricultural stakeholders, along with inventory repositioning and market creation options. In addition, of significance is the consequent shift in the balance between state/nation and federal/supranational equity and bargaining power, an increasingly relevant context where supply chains operate across a common but multi-jurisdictional territory, and implications for system-level outcomes, in this particular case equity, welfare economics, and food security. We conclude by pointing to the implications of CACP regimens, and their interplay, for the broader field of operations management and supply chain research.

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.