Futureproofing medicines supply

Transcription

1 OVERVIEW Futureproofing medicines supply The REMEDIES (RE-configuring MEDIcines End-to-end Supply) project is headed up by GlaxoSmithKline with research led by the University of Cambridge s Institute for Manufacturing. Launched in 2014, REMEDIES is a broad-based collaboration examining how the multibillion pound global medicines manufacture and supply sector can be reshaped to meet the needs, expectations and budgets of the 21st Century. Photo GSK

2 INTRODUCTION Dr Clive Badman OBE Vice President and Head of Pre-Competitive Activities, GSK Project Director, ReMediES The power of ReMediES is in its partnerships, bringing the power of the entire supply chain to bear on a series of problems. A single team can make small incremental changes as part of the supply chain but if you bring everybody together across the whole supply chain, examining where the difficulties are and helping work to put new solutions in place, then that is when you get a really high performing project. The prize, if we can crack the challenges we have set ourselves, will be for UK plc in attracting more investment and creating more jobs; for clinicians and researchers who will get the medicines they need in the quantities they need when they need them; for health economies as we can drive down costs and drive up quality; and for patients receiving medicines in the way that s best for them. Some successes so far... Moving from batch to flow: continuous processing delivering for GSK APIs Blacktrace launches Titan series

3 THE CHALLENGE Primary Manufacturing Massive inventory Environmentally unsustainable Not right first time? R&D Clinical supply chain fails to support agile clinical trials Secondary Manufacturing Using systems and materials unchanged in generations Systems designed for mass manufacturing Supply Shortages Tracking failures Failing to match innovation of other sectors CTech sales of microwave flow reactors Just In Time Automated Clinical Pharmacy

4 Clinical & Drug Substance Supply Chain Andrew Dwyer Head of Clinical Packaging Operations at GSK Leader, Clinical Supply Chain Platform If we can flexibly manufacture and supply clinical trial medicines to clinicians in days rather than months then we will offer researchers the opportunity to rethink how they design and operate their studies, potentially enabling the development of new medicines sooner and/or cheaper than is currently possible. FINDING AGILE WAYS TO SUPPLY CLINICAL TRIALS USING BIOCATALYSIS IN FLOW FOR CHIRAL AMINE SYNTHESIS Markus Schober Senior Scientist Synthetic Biochemistry, Advanced Manufacturing Technologies, GSK Continuous Synthesis of Chiral Amines Transaminases in Flow Workstream This is about coupling two key technologies, bio-catalysis and flow, by developing the use of transaminases in flow. This particular class of enzymes allows us to take readily available ketones and stereoselectively convert them to widely used chiral amines. This approach gives a more environmentally friendly, metal free way of catalysing chemistry and also allows us to do chemistry that is more selective or can t be accessed using traditional chemical catalysis. Flow chemistry is allowing us to do things more efficiently and to do processing that is not possible in a batch process. By coupling the two together we hope to broaden the implementation of both technologies within the pharmaceutical industry leading to shorter and more efficient API manufacturing routes.

5 Stewart Mitchell Project Manager, CMAC Future Manufacturing Research Hub, University of Strathclyde Continuous Manufacturing Workstream We are trying to take the learnings and experience from industry and do things differently. The industry has significant underutilised assets, investment is made into assets for manufacture of products which often do not make it through clinical trials. Often, where a medicine is being widely used, there is still a lot of underutilisation for a number of reasons. Many facilities are running down in the 30 to 40% utilisation range. For example, if a process is made in batch in a large 10,000 litre vessel and there is a mistake resulting in a reject batch, this results in a lot of wasted energy and materials. In contrast, if you have a process manufacturing continuously, which is constantly monitored and conditions are adjusted continuously to ensure the quality and productivity, then yields will be a lot better and it s going to be a lot more cost-effective. ADVANCING CONTINUOUS MANUFACTURING SUPERCRITICAL FLUIDS IN PARTICLE ENGINEERING Paul Thorning CEO Crystec Ltd Supercritical Fluid-Based Crystal and Particle Engineering Workstream The first challenge, and the most common one, is that the molecules that pharmaceutical companies produce are often highly insoluble. Sometimes they are also unstable. Our technology helps to make it easier for these drugs to be dissolved and to be capable of being turned into medicines. We solve problems that relate either to the crystallisation of molecules, which affects how they dissolve and how stable they are over their shelf-life, or to their size and shape, which can affect both the performance and ease of manufacture of the medicine. Through controlling the crystallinity, size and shape of a drug particle you can, for instance, transform a medicine from a hospital injection to a more convenient inhaler, which can be self-administered by the patient.

6 Drug Product, Packaging & Commercial Supply Chain Heidi Keeling Packaging Strategy Lead, AstraZeneca Next Generation Packaging Materials Workstream Our aspirations in this workstream are to standardise and remove complexity where we can, to innovate execution methods using IT, explore new materials and printing technology. We hope to make headway in each area that will give us advantages going forward, such as helping to improve training and compliance and lead to a reduction in lead times and cost. LOOKING FOR NEW PACKAGING MATERIALS IMAGINING NEW PATHWAYS EXAMINING PRIMARY TO SECONDARY TRANSITIONS USING PRINTABLE Liz Meehan Pharmaceutical Technology & Development, AstraZeneca Primary to Secondary Pharmaceutical Processing Workstream The technology platforms that we choose to manufacture a drug substance or a drug product have to be flexible and agile enough to address clinical and commercial supply chains at the volume and throughput for the products that are required. We are looking at how we can take into account both material attributes and process parameters to develop and implement continuous manufacturing processes, incorporating in-line process and product monitoring and control, to make robust medicines more repeatably and for a wider range of products.

7 Jagjit Singh Srai Head of the Centre for International Manufacturing, IfM, Department of Engineering, University of Cambridge Leader, ReMediES Commercial Supply Chain ReMediES brings together academics, regulators and healthcare professionals alongside teams from global pharmaceutical companies, major contract manufacturing organisations, equipment manufacturers and international logistics specialists, to scrutinise the many different elements of the medicines end-to-end supply chain from patent to patient. We see a lot of investment in novel processing, formulation and packaging. In all of this, adoption of the patient s perspective for them the front end of the supply chain is crucial. If the new production technologies allow us to do late stage customisation, where in the process is best for that late customisation to take place? Is it in a GMP facility, a warehouse or depot, a centralised pharmacy, at the local pharmacy? Or, ultimately, could it be at the point of use? Digital network design tools being developed can help us identify the ultimate solution. BETWEEN MEDICINE PRODUCTION AND PATIENT ELECTRONICS IN PACKS TO TRACK QUALITY Tim Marsden Project Manager, Printable Electronics, at the Centre for Process Innovation (CPI) Printable Electronics and Intelligent Packaging Workstream Although of vital importance within small molecule pharma, as we see biologics and biologic drug development where that control of quality is much more challenging you will see an improvement in the monitoring of quality as well. You re not just building in tracking of where it is, but also how it has been handled. You can say whether it has been dropped, whether there has been a change of pressure or temperature or, perhaps, whether something has come loose during shipment. So, you can look at a whole host of supply chain issues around handling and environmental conditions and assess the integrity of the product as a result of how it has been handled.

8 The ReMediES Partners Funded by: 11.5m contribution from industry 11.5m of government funding through The Advanced Manufacturing Supply Chain Initiative (AMSCI) and the Scottish Funding Council Get in touch Project Director Dr Clive Badman, GSK Website enquiries Dr Ettore Settanni, University of Cambridge Research Director Dr Jagjit Singh Srai, University of Cambridge Media enquiries John Macgill +44 (0)