Medicines Manufacturing Innovation Centre
Medicines ManufacturingInnovation CentreStrategy 2021 - 2024Looking to the future of pharmaceutical production
“The Medicines Manufacturing Innovation Centre has a clear purposeto create a sustainable, competitive advantage in UK pharmaceuticalmanufacturing. By innovating in close partnership with industry, wewill bring agile, scalable, and flexible manufacturing technologiesto commercial reality. The productivity and sustainability gainswe achieve will reduce the time and cost of pharmaceuticaldevelopment, delivering greater benefit to patients.To enable this ambition, we have created a strong and flourishingpartnership based on our shared commitment to deliver impact forsociety and the economy. We do this by joining up our world classresearch, development, and innovation capabilities and by workingwith our stakeholders to deliver results at pace.”Frank MillarChief Executive OfficerCPI
About the partnershipContentsCPI is part of the UK’s High Value Manufacturing Catapult. Wehelp companies to develop, prove, scale-up and commercialisenew products and processes. Our vision is to create a healthiersociety, cleaner environment and a vibrant UK economy byensuring every great invention gets the best opportunity tobecome a successfully marketed product.Foreword. 5Introduction. 6Our vision and mission. 10Our values and behaviours. 12Our operating and partnership model. 14Alongside partners in industry, government and academia, CPI has createdthe Medicines Manufacturing Innovation Centre to develop, prove andcommercialise disruptive technologies for the pharmaceutical industry. Weoperate a model focused around Grand Challenges where the pharmaceuticalindustry and its supply chain work together to identify and overcome majorindustry hurdles, aiming to reduce the time, resources and cost of medicinesmanufacturing, to ultimately deliver benefits to patients.Our grand challenges. 18The centre. 22Our strategic plan. 26Commercialisation of advanced technology. 28Skills and capabilities. 30Collaboration and partnerships. 32Sustainable technology leadership. 34Business growth. 36Our roadmap. 43Our partners and team. 50
“The Medicines Manufacturing Innovation Centre plays avital role in Scotland’s economic recovery from the globalpandemic as we seek to create new, sustainable, high qualityjobs and capitalise on future global medicines and healthcareopportunities. With the capacity to create hundreds ofjobs directly and across collaborative supply chains, thereis no other facility like this in the world. It’s a fantasticendorsement of Scotland’s global excellence in high valuemanufacturing to attract investment like this, drawing on ourskills, innovative companies and academic expertise.Industry leadership and co-investment has been central toshaping the centre and will remain at the heart of what makesit a success. We’re proud to contribute 15 million fundingalongside our industry expertise to help deliver the MedicinesManufacturing Innovation Centre, providing a platform forcompanies across the UK to collaborate, innovate and developworld-leading medicine manufacturing processes andtechnologies.”Linda HannaInterim MDScottish EnterpriseForewordLooking to the future of pharmaceuticalmanufacturing and supply is at the heart of ourwork at the Medicines Manufacturing InnovationCentre, and what we have been engaged in sincewe were launched in 2018 by CPI and our foundingpartners University of Strathclyde, UK Researchand Innovation (UKRI), Scottish Enterprise (SE) andindustry partners, AstraZeneca and GSK.We are proud of what has been achieved over thelast two years. The initial technology innovationsare on track, the facility design will be state of theart for pharmaceutical manufacturing and we arebuilding a strong teamIn this document, we set out our refreshedstrategy for the next three years, focussing onpromoting our potential through global cooperationand engagement and overcoming industry’sself-identified ‘Grandest Challenges’ through acollaborative approach.In developing this refreshed strategy, we were drivenby our ambition and commitment to help solve thechallenges that the pharmaceutical industry facesnow and in the future, including those that havebecome even more apparent and critical during theCOVID-19 pandemic.There is now, more than ever, a need to addressglobal health challenges, equalise access tomedication and streamline supply to patients. Wecan do this by rethinking current manufacturingprocesses and innovating new technologies thatcan quickly adapt to the changing needs of globalpopulations.Our strategy is based on five pillars that driveour ambitions into the wider global innovationecosystem. We lay out our priorities under each pillarand bring them all together into a roadmap whichsummarises our plan of action over the next threeyears. We will track progress of our objectives in anannual report.The Medicines Manufacturing Innovation Centrepartnership has now grown to over 20 organisationsand this strategy provides a unique opportunityfor continued collaboration within the innovationecosystem and for the future of pharmaceuticalmanufacture. With focus, hard work and innovativethinking, I believe this strategy can be deliveredeffectively in the coming years.Dave TudorManaging Director of the MedicinesManufacturing Innovation Centre,Biologics, and QualityCPI5
IntroductionKey challenges pharmaceuticalcompanies and healthcare face todayAgeing populations, the cost of drug developmentand the need for environmentally sustainablemanufacturing processes are just some of thechallenges facing the pharmaceutical industry today.The increasing cost of global healthcare systemshas led to a need for more cost-effective medicinesdriving the need for a step change in efficiency andflexibility of both the manufacturing process andmedicines supply chains.6Coupling these challenges with the developmentof new, patient-specific and stratified medicineswill help clinicians to choose the right medicine forthe right patient at the right time, leading to overallbetter patient outcomes.Future of pharmaceutical developmentand manufactureNew medicines are trending towards more complex,stratified products with lower volumes. This in turnis accelerating the move from the traditional largebatch manufacturing approach, based on forecastdemand with supply continuity buffered by largeamounts of inventory to continuous and minibatchmanufacture.As the requirement for smaller batches, multiproduct equipment trains and distributed supplyEconomic impact summaryoptions increases, there is an opportunity tofundamentally change the way that medicines aremanufactured.Emergent, data driven technologies andmanufacturing innovation are increasing theresponsiveness of the supply chain reducing timeto market for all high-tech supply chains fromaerospace to FMCG. However, in the pharma sectorthey are not being adopted at the same rate due toperceived risks, regulatory compliance concerns andfinancial constraints.There is a clear opportunity to develop and driveadoption of manufacturing methods that are moreagile, cost effective and environmentally sustainable,including: Integration of manufacturing assets via digitalplatforms for real-time supply chain visibility Flexible and modular manufacturing forstratified medicine production Ultra-efficient production, enhancingproductivity with reduced capital outlays drivinga lower overall cost of goods Application of digital twins for the developmentand advanced control of the manufacturingprocess Accelerated paths to market throughstreamlined clinical trials supply of medicines topatients.Medicines Manufacturing Innovation Centre will generate over 100high value jobs and is forecast to generate 200 million investment inadvanced technologies over the first five years.Medicines Manufacturing Innovation Centre demonstrates a verystrong business case for both the UK and Scottish Governments withcompetitive ROI, SME growth, and job retention or creation.Medicines Manufacturing Innovation Centre is expected to generatesubstantial wider economic impacts, in particular relation to: Increasing the attractiveness and competitiveness of the UK as a location forinward investment Creation of an international beacon in medicines manufacturing over the next5-10 years bringing increased international engagement and potential to attractfirms that do not currently have a presence in the UK Empowering existing major sites of economic activity in the UK to gain a greatershare of international investment Safeguarding existing economic activity in the related supply chain in the UKTo ensure a holistic appraisal of the success of Medicines ManufacturingInnovation Centre, the partners have established a set of KPIs tomeasure the impact of our innovation.The contribution of the pharmaceutical sector extends beyond theactivities of pharmaceutical companies themselves, with their outputsupporting employment and income right across the UK economy.Overall, the Medicines Manufacturing Innovation Centre projectdemonstrates good value for money for the proposed public sectorinvestment and contribution from Scottish Enterprise and UKRI.7
Why the industry needs the MedicinesManufacturing Innovation CentreThe 2017 UK Life Sciences Industrial Strategyrecommended that sustained industry success couldbe achieved via a partnership approach with thepharmaceutical industry, academic research hubs andgovernment agencies to accelerate development andintegration of a new generation of manufacturing.8The Medicines Manufacturing Innovation Centrewas conceptualised by the University of Strathclydeand created by six founding partners to deliver thisgoal through a portfolio of ambitious and digitallytransformational Grand Challenges.Medicines Manufacturing Innovation Centre buildson collaborative early stage work and proof ofconcept activities carried out at research centres.Commercialisation of these ideas is generallyexpensive and carries risk, so an individual companymay not be able to justify the spend, despitethe potential return on investment. Therefore,we designed our business model to enablecommercialisation of such ideas through fullycollaborative innovation in our Grand Challenges.By sharing costs, risks, knowledge and ideas,having strong regulator relationships and providingopen-access innovation services, the MedicinesManufacturing Innovation Centre will play a key rolein the UK medicines development and manufacturinginnovation infrastructure, investing in digitalmedicines manufacturing innovation to tackle today’shealth and environmental challenges and those ofthe future.The UK medicines developmentand manufacturing innovationinfrastructureThe UK and Scottish Lifesciences Strategies havea clear focus to drive innovation outcomes andadvanced technology capabilities through thecreation of leading innovation centres. MedicinesManufacturing Innovation Centre will play a pivotalrole within this innovation ecosystem.9
Our visionOur missionTo be internationally recognised for translating advanced technologyinto all areas of the pharmaceutical supply chain, to create a vibrant UKtechnology ecosystem.To innovatively solve industry-wide technology challenges andmaximise digital technology opportunities within the pharmaceuticalsupply chain.The Medicines Manufacturing Innovation Centre partners believe that innovativetechnologies should be at the heart of modern medicines manufacture, leading to:Through shared ideas, risks and costs, this partnership will help companies develop,demonstrate and commercialise the next generation processes for medicinesmanufacturing. It will enable new advanced technologies to be proven at scale in aGMP-compliant environment accelerating the commercialisation of more agile andsustainable manufacturing processes within the medicines supply chain.10A healthier societyAn enhanced UK economyImproved healthcare outcomes throughnovel medicines, reduced costs andincreased access for patientsOnshoring expertise and encouragingmanufacturing back to the UKA cleaner environmentMinimised environmental impact (netzero agenda)Inward investmentLower costs and driving growth in UKmanufacturingRevenue growth to thepharmaceutical industryOpen access to innovative technologyleading to accelerated productdevelopment and commercialisation11
VisionaryEnterprisingWe have foresight of how sciencecan help society.We turn innovation into wealth.ConnectedProfessionalWe enable unique connectivity andengagement.We always deliver on our promises.InspiringInclusive, diverse,and fairOur valuesand behaviour12How we go about our work is shaped by our values and undertaken inline with our four key behaviour standards:StandardsRisk managementFollowing rulesBeing mindfulInvolvementCommunicationsGetting involvedSpeaking upOur passion energises those aroundus.13Treating those in our team andothers with respect in all of ourinteractions, behaviours, anddecisions.
Public sectorpartnersOur operating andpartnership modelFounding partners areScottish Enterpriseand UK Research andInnovationTechnologypartnersWe employ a collaborative operating model, creating partnershipsbetween industry, academia and government. This flexible model enablespartners to join through a combination of direct funding and benefit inkind contributions towards resources or technology.1415In our mobilisation phase, prior to centre completion, we used the expertise andfunding from our founding partners for our initial Grand Challenges and to build theGMP Centre in Glasgow.As we continue to shape the Grand Challenges to achieve our mission, we haveexpanded the Medicines Manufacturing Innovation Centre to over 20 organisationsand are always looking to expand our network of partners and collaborators to help usdeliver the right innovation.Our ambitious Grand Challenges are each unique multi-million-pound projects andas we define our funding strategy and industry partner groupings for future GrandChallenges to make the most impact, we envisage our funding coming from acombination of diverse sources.We intend to evolve the operating model to introduce a fee for service and/or licenseopportunity for industry to utilise the new technology.CPI andCPI Innovation ServicesIndustrypartnersFounding partnersare GSK andAstraZenecaStrategicacademic andresearch partnersFounding partner isUniversity of Strathclyde,Glasgow
“The Technical Advisory Committee has two roles: tocomment on the progress of the Medicines ManufacturingInnovation Centre’s Grand Challenges and to provideinsight on innovations that could benefit medicinesmanufacturing and patient care. The TAC combines thetechnical expertise of the centre’s partner organisationsand draws on knowledge from other sectors to advise theteams delivering the Grand Challenges and to support theexecutive leadership. It is important that the MedicinesManufacturing Innovation Centre can access the technicalexpertise that helps it achieve its mission and in thatcontext the TAC’s contributions are important to thesuccess of the innovation centre.”David LittlejohnChair of the Medicines Manufacturing InnovationCentre Technical Advisory Board“It has been great to collaborate with industry, government,academia and others over the past two years in supportingthe operationalisation of the Medicines ManufacturingInnovation Centre and its initial Grand Challenges. Workingtogether to secure an internationally competitive leadershipposition for the UK in life sciences for the long-term isour objective and we have made great start. GSK has longadvocated the value of collaborations like the MedicinesManufacturing Innovation Centre to capitalise on our worldclass science base and deliver innovation that drives growthand improves patient care. As a major life sciences companybased in the UK and one of its biggest investors in research,we have been delighted to actively contribute as a foundingpartner and look forward to its future evolution.”Andy DwyerGlobal Manufacturing Technologies DirectorGSK
Grand challengesOur Grand Challenges are a portfolio of collaborative projects, designedto be digitally disruptive and transformational, addressing the keychallenges raised by the industry consortia.18These ambitious projects aim to reduce inefficiencies, environmental footprint andcosts of drug development and manufacture to the industry but are ultimatelydirected at bringing significant benefits to patients. To maintain the disruptive thinking,Grand Challenges must meet one or more of the following criteria:Flexible and modular designsfor continuous manufacturingDigitally enabled real-timequality controlDigital product and processdesign and operationSupply chain integration19GRAND CHALLENGE 1Continuous direct compression digital testbedGrand Challenge 1 is redefining how we produce oral solid dosagemedicines more robustly and efficiently using continuous directcompression (CDC). A world class demonstrator will be delivered toprove CDC principles for commercial scale. The benefits demonstratedwill accelerate industry’s adoption of streamlined, agile formulationtechnologies and digital twins in drug product development andmanufacture, to reduce the development burden, cost to patients andcarbon footprint of production.
2021GRAND CHALLENGE 2GRAND CHALLENGE 3Automated clinical trial packing and QPrelease platformCost effective and sustainableoligonucleotide manufacturingCurrent manufacturing processes for clinical trial products struggle withlong lead times and are often ill-suited to adaptive clinical trial supply.Grand Challenge 2 will deliver a modular automated clinical bottlepacking line that can be linked to a qualified person (QP) dashboard forreal-time batch release, enabling agile just-in-time (JIT) multi-oral soliddosage product packing and smart labelling. This will have significantbenefits, ultimately reducing material waste, cost and environmentalfootprint and giving patients a faster and cheaper supply of clinical trialmedicines.Currently, oligonucleotides are time-consuming and expensiveto produce. Grand Challenge 3 is redesigning the oligonucleotidemanufacturing process through development of scalable, liquid phaseAPI processes which will enable oligonucleotides to be manufacturedon an industrial scale, at speed and at lower cost. Through this GrandChallenge, we will enable the industry to provide this exciting class ofnew medicines to wider patient populations at affordable prices and in asustainable way.
The centreA world class GMP facility for innovation in medicines manufacture.The Medicines Manufacturing Innovation Centre is a state-of-the-art facility adjacentto Glasgow Airport in Renfrewshire, Scotland and is part of the Advanced ManufacturingInnovation District Scotland (AMIDS). It will create a capability where highly skilled people candevelop advanced technology and our team can train the workforce of the future.22The aim of the centre is to become an internationalbeacon for innovation in medicines manufacturing,incorporating capabilities for development andmanufacture of drug substances and drug productsin a GMP-compliant environment.continuous, digital and autonomous manufacturing.As a flexible and adaptable building, the centreenables industry, academia, healthcare providersand regulators to work collaboratively to addresschallenges along the medicines supply chain.In the first two years the centre has attractedover 80 million of investment, supporting directand indirect employment opportunities. Indirectemployment will be generated through start-ups,SMEs and large companies who will grow theirbusinesses using the transformative manufacturingtechnologies developed within the MedicinesManufacturing Innovation Centre.The clean rooms each support activities and servicesfor the Grand Challenges. Users can evaluate, testand prototype processes using an array of advancedIndustry 4.0 manufacturing technologies includingFurthermore, the events space provides a hub forpharmaceutical sector focussed and knowledgesharing activities.23
“The Medicines Manufacturing Innovation Centre is aglobally unique capability where people drive forwardinnovation to prepare the pharmaceutical supply chainfor next-generation medicines. This collaborationbetween government, academia and industry willenable digitally disruptive technologies to be provenat scale resulting in an enhanced UK innovationlandscape, a minimised environmental impact, andultimately, improved patient outcomes.”Maureen WedderburnChair of the Medicines ManufacturingInnovation Centre Supervisory Board
Developali s26emcionerstra teCo m mOur strategic planDeIn order to achieve our vision of accelerating towards a vibrant UKinnovation ecosystem of cross supply chain innovation, it is essentialfor our strategy to focus on how we achieve key parts of our missionto develop, demonstrate and commercialise ‘disruptive’ technologysolutions into the pharma industry.27We have developed five strategic pillars which underpin this mission. Within eachstrategic pillar, we have identified the key priorities over the next three years and thisis summarised in our Strategic Roadmap.Commercialisation ofadvanced technologiesAddressing industry’s greatestmanufacturing challenges throughour technology innovation.Sustainable technologyleadershipPromoting a sustainable future forthe industry.Skills and capabilitiesEnabling the development andsustained deployment of thetechnology into the wider ecosystem.Business growthEnsuring we have the resourcesand investment to achieve our boldambitions.Collaboration andpartnershipsEstablishing and fosteringrelationships to accelerate and realisethe full value of the technology.
To deliver on our priorities, we will:Commercialisation ofadvanced technologyWe will continuously develop and demonstrate advanced technologies that increase theproductivity of medicines manufacturing to increase environmental sustainability and patients’access to affordable medicines.28We will become a technology leader in the industry allowing us to accelerate the commercialisation of thesetechnologies. Through our continuous engagement with industry and academic partners, we will influencethe best-in-class future technologies, identify the priorities to support in future innovation and enable themanufacturing component of interconnected digital supply chains.To deliver on our priorities, we will:Drive current Grand Challenges to completionsThe Grand Challenge teams will maximise delivery of benefits and ensure the GrandChallenges are appropriately governed.Decide future Grand ChallengesDeliver the benefits from the GrandChallengesWe will focus on executing our current Grand Challengepipeline and demonstrating the clear benefits toour partners. This includes the core operational andenvironmental benefits of the technologies themselvesand the consequent financial benefitsEvolve with intent into new technologyareasWe will maintain the pace of our disruptive, transformativeGrand Challenges and evolve beyond our initial oralsolid dosage arena, leading the wider industry into newtechnology areasDemonstrate connected supply chainWe will design for data connectivity across the supplychain, developing data driven ‘smart factory’ technologiesfor state-of-the-art connected processes. These willexemplify the benefits of an intelligent digital factoryby bringing visibility upstream and downstream ofmanufacturingThrough an in-depth understanding of the industry’s key challenges and an effectivebusiness process, we will champion the Grand Challenges that propel the biggest benefitsto the industry.Build out our connected supply chain narrativesWe will articulate how our work in smart factory and data connectivity fits in to thewider end-to-end supply chain.29
Skills and capabilitiesThe partnership will have the skills and capabilities to deliver the Grand Challenges and willsupport creation of the long-term skills and capabilities in the wider ecosystem for thesuccessful commercialisation of the technology solutions in the pharmaceutical industry.30Develop and support delivery of theindustry ecosystem requirements forsustainable technology commercialisationWe will identify and establish new mechanisms for thepartnership to influence, accelerate and contribute to thedevelopment of the pharmaceutical sector skills agendafor advanced technology, both externally and internallywithin CPI.Deliver the internal growth planTo support the delivery of our Grand Challenges andoperation of the centre, we will execute the people growthplan: upskilling our cuxrrent staff, recruiting to fill ourknowledge gaps and partnering with organisations to bringin specific skill sets.To deliver on our priorities, we will:Define the required skills and capabilities to deliver GrandChallengesWe will review internal knowledge and skills and perform a gap analysis against therequirements for the Grand Challenges.Identify key partners and innovation centres to connect with forknowledge sharing opportunitiesWe will work to understand similar Centre of Excellence training and knowledge sharingmodels for implementation.Connect with existing mechanisms and forums to influence thewider skills agendaWe will become part of skills strategy groups and where appropriate, we will influencestrategic academic research.31
Collaboration andpartnershipsOur relationships with partners and regulators are central to propelling solution delivery anddriving the adoption of advanced technology within the pharmaceutical industry.We will unite the brightest minds in a collaborative space and grow our network within the wider ecosystem. Wewill collaborate at the forefront of technology development to have a bigger impact on the global community andestablish the UK as a great place to introduce and licence new technologies.To deliver on our priorities, we will:Develop robust communications and engagement plans forcurrent partnersWe will collaborate with current partners to understand where they fit into the strategicvision.32Build and strengthen existing partnershipsWe will continue to deliver technology innovation with ourexisting partners. We will forge stronger relationships withthem through timely and effective communication.Establish ourselves in a leading position inthe global innovation ecosystemWe will be the partner of choice within the pharmaceuticalindustry and form new international partnerships withinthe wider academic, philanthropic and digital innovationecosystem, based on common technology agendas,collaborative innovation and the potential for impact. Wewill connect, share and drive engagement with the SMEcommunity and through our technology, connect networksof existing and future expertise.Collaborate to support regulator alignmenton regulatory landscape and prioritiesWe will reinforce and establish strong relationships withglobal regulators through structured work streams and byinteracting at the right time, positioning ourselves as thevoice of medicines manufacturing innovation and as theintermediary between innovative technology companiesand pharmaceutical regulation. We will support alignmentbetween the regulators on regulatory landscape andpriorities, collaborating on regulatory frameworks foradoption of digital innovation in medicines manufacturingand providing robust demonstrations of advancedtechnology in a GMP compliant environment.Identify new partners to fill strategic gapsWe will partner globally and in the wider academic and innovation ecosystem.Define regulator strategy and planWe will create and execute a clear regulator engagement plan.33
Sustainable technologyleadershipThrough the delivery of our Grand Challenges and partnerships with environmental expertgroups, we will become recognised thought leaders in advanced technologies that deliverenvironmentally sustainable outcomes.34We will additionally demonstrate our commitment to sustainability through all our activities and behaviours atthe centre. In these ways, we will proactively support the pharmaceutical industry’s environmental sustainabilitygoals.Drive net-zero through innovationleadershipEvidence our commitment to theenvironment through all our activitiesWe will drive the environmental sustainability agenda inthe industry in two ways. Firstly, by demonstrating theenvironmental benefits of the technologies in our GrandChallenges. Secondly, by leveraging relevant forumsand relationships to articulate those benefits, raiseawareness and drive the industry to adopt environmentallysustainable advanced technologies.Through utilising novel supply chain technologies, we willevidence our environmental commitment and the netzero contributions of all our activities: from our supplychain, technology and delivery of Grand Challenges, in ourbehaviours, design and operation of the centre and in ourconsideration of new projects undertaken.To deliver on our priorit
collaborative innovation in our Grand Challenges. By sharing costs, risks, knowledge and ideas, having strong regulator relationships and providing . open-access innovation services, the Medicines Manufacturing Innovation Centre will play a key role in the UK medicines development and manufacturing innovation infrastructure, investing in digital
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