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1、Biomanufacturing Policy Summit 2023 Report&RecommendationsBiomanufacturing Policy Summit 2023 ReportIntroductionAbout EuropaBio&the Biomanufacturing PlatformBiomanufacturing Definition 101 Biomanufacturing for Europes industrial transition within a competitiveglobalised worldI am biomanufacturing Ad

2、vanced healthcare:Role and growth in Europe Biomanufacturing for resilience,competitiveness,and sustainabilityEuropes ambition and pathway for biomanufacturingBiomanufacturing recommendationsSummit participant organisationsTable of Contents2312141565410118On 15th March 2023,EuropaBio hosted its inau

3、gural Biomanufacturing Policy Summit inBrussels,marking the first major milestone from its newly established BiomanufacturingPlatform.The Summit had the mission of setting a vision for Europes global innovation,competitiveness,and sustainability through biomanufacturing,whilst raising awarenessamong

4、st policymakers and other stakeholders.The Summit established a starting point,a first step for a biomanufacturing policy journey to betravelled by European stakeholders.80 participants represented translational research,cross-sectoral industry,expert support sectors,investors,policy makers,European

5、 advancedtechnology associations plus national biotech associations.Starting from a European focal point,the Summit also recognised the global nature of abiomanufacturing transition,with significant global regions already signposting strategy,policyand investment as their industrial focus changes.Th

6、e half day meeting had four elements;keynotes set the scene for Europes policy,competitiveness and place in the world before I am Biomanufacturing told the story of whatbiomanufacturing looks like for industry,society and Europes development.Round tablediscussions then set ambitions,challenges and p

7、riorities before a closing panel looked to thefuture.Through presentations,debates,and proposals,participant dialogue built an ambition forEurope reflected in this Summit report.This report presents a synthesis of contributions and discussions and offers an ambition andpathway for industrial goals m

8、aking use of the skills,infrastructure and policy and regulatoryframeworks through which Europe develops its industrial,environmental and societal future.It also showcases a Biomanufacturing 101 definition presented for the first time at the Summit.This definition will underpin the Biomanufacturing

9、Platform,with the intention to developfurther over time,supported from case studies and narratives.Finally,the report closes with ten recommendations to underpin EuropaBios work over thecoming years with members and stakeholders to support strategy,policy and regulatoryframeworks to deliver biomanuf

10、acturing in Europe.Biomanufacturing Policy Summit 2023 ReportIntroduction3Biomanufacturing Policy Summit 2023 Report EuropaBio-The European Association for Bioindustries is Europes largest and most influentialbiotechnology industry group.Founded in 1996 to represent the interests of the biotechnolog

11、yindustry at European level,EuropaBio speaks for innovation from the early days of SME start-ups,through to global multi-nationals.It seeks to create a positive legislative,regulatory,andfinancial environment for biotechnology,so that impacts are maximised world-wide,andEuropes world class research

12、translates to economic,employment,sustainability and quality oflife advances.The company landscapeEuropaBio represents companies across sectors.Members range from next generation biotechstart-ups,SMEs and growing companies through to globally recognisable companies.Thesecompanies are revolutionising

13、 our health,living world and economies through biotechnology,catalysing a transformation to biological processes and products in all aspects of our lives.The national voiceNational and regional Association members are the backbone of EuropaBio,representing over2600 biotech companies,of which the maj

14、ority are SMEs.These members help to shape thefabric of Europe for biotechnology and ensure that national interests work in alignment as avoice for biotechnology.Over its 26 year history,EuropaBio has grown alongside the scientific,business,and societal framework of biotechnology,working with nation

15、al,European and globalstakeholders to represent a frontier technology in its continuing development.About EuropaBio4About the Biomanufacturing PlatformEuropaBios Biomanufacturing Platform has the mission to represent biomanufacturing at thehighest policy levels in Europe,to ensure that it is visible

16、 and recognised within the industrialstrategy and Europes green and digital transitions.EuropaBio champions biomanufacturingacross its Healthcare,Industrial Biotechnology and National Associations Councils and a cross-sectoral Platform brings these voices together to accelerate Europes growth.Europa

17、Bios Biomanufacturing Platform addresses the policy and wider frameworks throughwhich biomanufacturing is delivered.Together with members and stakeholders,it addresseshow economic growth,employment and resilience are achieved through policy,legalframeworks and regulation at EU and national levels.An

18、imal and human cells;Plants,either individual cells or whole plants;Micro-organisms such as yeast,bacteria,fungi,and microalgae;Viruses.Immunotherapy,where human cells are a biomanufactured product,having been modifiedto target cancer using the patients own immune system.Food ingredients including a

19、lternative proteins and other ingredients such as vitamins canbe synthesized by microorganisms through a biomanufacturing process commonly referredas fermentation.Viral vectors are a biomanufactured tool where viruses are adapted to deliver genes intocells for use in gene therapies or in vaccine man

20、ufacture.Creating novel products that were not previously available:Advanced therapies and vaccinesare examples,allowing previously untreatable or incurable diseases to be addressed.Transforming current manufacturing:Biomanufacturing processes can create products usingreduced energy,resources and re

21、quirement for fossil fuels,fewer petrochemical products,simplifying processes,plus reducing demands on biodiversity through replacing the need fornatural extraction.What is biomanufacturing?Biomanufacturing is the use of biological mechanisms to i)synthesize products ii)act as toolsor iii)undertake

22、processes,at a scale required for commercial use.Biomanufacturing can use different sources for the desired biological mechanisms:Biomanufacturing can either use biological processes to synthesize desired products,or thebiological material is the product itself.What are different types of biomanufac

23、turing?How does biomanufacturing play a role in our lives?Biomanufacturing is applicable across many sectors,helping to create products and processesthat are part of our everyday life,including medical therapies,food and animal feed ingredients,fuels,textiles,plastics,cosmetics,detergents,and interm

24、ediates for other manufacturingprocesses.This all contributes to the bioeconomy,which is recognised as economic activity linked to lifesciences.Why is biomanufacturing important?Biomanufacturing is increasingly used around the world,as scientists and engineers are able toachieve reliable and consist

25、ent manufacture at higher scales and with increasing complexityand efficiency.The primary drivers behind the growth of biomanufacturing include:Biomanufacturing Policy Summit 2023 Report Biomanufacturing Definition 1015Biomanufacturing is a result of biotechnology innovation translated into industri

26、al process andcapacity.Europes industrial transition is essential for a sustainable and competitive future.Thesustainability market is growing at tremendous rate(anticipated at 40%of global GDP over thenext 30 years 1).Sustainability is not only about reaching crucial environmental targets butinclud

27、es value creation and return on investment for Europes society.Industry is an important stakeholder in ensuring Europes values of cohesion and democracy.Ata global level,it is increasingly acknowledged and acted upon that economic developmentthrough sustainable solutions like biotechnologies support

28、 wellbeing,economic growth andgeopolitical stability.Countries worldwide have recognised biomanufacturing as key toindustrial transition,including the United States,China and other significant economies such asJapan and Brazil.In the USA,the Bioscience Industry directly employed over 2M people in 20

29、21 and had a totalimpact of over 10M jobs and 3 trillion dollars of economic output 2.In September 2022 theWhite House announced an“Executive Order on Advancing Biotechnology and BiomanufacturingInnovation for a Sustainable,Safe,and Secure American Bioeconomy”3 focusing on health,climate and energy,

30、food and agriculture,and supply chain resilience.Europe still holds a strong research position globally for pharma and biotech and has strongbiomanufacturing assets.However,this is counteracted by global trends in investment,patentsand public spend in R&D where Europe is increasingly out-performed.T

31、his trend is underpinnedby features such as slower speed to patients through regulatory and reimbursement pathways.It is a factor influencing Europes ability to mature research into therapies,with the knock onimpact for scale of investment into biomanufacturing,both within biotech companies andcontr

32、act manufacturers.Biomanufacturing Policy Summit 2023 Report Biomanufacturing for Europes industrialtransition within a competitive globalised worldSummit Keynote SpeakersBiomanufacturing in Europes industrial transition Peter Droll,DG RTD,European CommissionBiomanufacturing as a global transition:U

33、S Executive Order for Biomanufacturing in focus Hilary Stiss,Biotechnology Innovation Organization(BIO)Quo vadis European Biomanufacturing innovation in a competitive,globalized world Wojciech Nowak,Novartis61 Boston Global Consulting,Looking to nature for the next industrial revolution,2021.2 TECon

34、omy/BIO The U.S.Bioscience Industry:Fostering Innovation and Driving Americas Economy Forward 2022.3 Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable,Safe,and Secure American Bioeconomy|The White House.Biomanufacturing Policy Summit 2023 Report 7BELGIUMS E

35、CONOMIC DEVELOPMENT THROUGH BIOMANUFACTURING-BIO.BE Biomanufacturing is key to Belgiums industry growth and economic development following severaldecades of political prioritisation and investment within a national biomanufacturing strategy.Between2011 and 2021,employment increased by 150%to 37,505

36、FTE,exports by 240%to 83bn and R&D by 240%to 5.1bn,with a value-added increase of 200%to 11.6bn 1.Belgium was at the forefront of theresponse to Covid,with the first large scale manufacture,significant clinical trials and a major exportbase for the vaccines worldwide.Biomanufacturing investments int

37、o Belgium have included Pfizer,LegendBiotech/Janssen Pharmaceutica,Univercells/Exothera,Eurogentec Kaneka,Takeda,GSK,UCB and Sanofi.PLANTS AS SINGLE USE BIO-REACTORS-SWIFTPHARMABiomanufacturing is integrated into the widerpharmaceutical industry,often by replacingchemical ingredients or processes.Sw

38、iftPharma is aBelgian start-up that uses plants as single-usebioreactors.Through agrobacterium infiltration,plants can then produce desired proteins forextraction and purification,able to manufacturevaccines,antibodies,enzymes and other products.The rest of the plant can then be used for energy,bioc

39、har and carbon dioxide removal certificates.Useof plants allows rapid,flexible and modularbiomanufacturing,accelerating pharma substancemanufacturing from 12 to 3 months.BIOMANUFACTURING IN DAILY LIFE:RHAMNOLIPIDS-EVONIK Biomanufacturing contributes to everydayproducts,such as cosmetics and detergen

40、ts and isintegral to their transformation into moresustainable products.Evonik,has built the worldsfirst industrial-scale production facility forRhamnolipids,a type of biosurfactant,biomanufactured through microorganisms.Rhamnolipids are 100%renewable and fullybiodegradable with very low water toxic

41、ity whileretaining high efficiency as surfactants.Evonik hasintegrated Rhamnolipids into products such asdetergents for dishes and clothes,shampoos,andtoothpaste.A competitive advantage throughbiomanufacturing in Europe is the ability to co-create products with local customers.Biomanufacturing Polic

42、y Summit 2023 Report I am biomanufacturingSummit Case StudiesResilience,sustainability and competitiveness:Biomanufacturing in daily life Ute Schick,Evonik Operations GmbHGrowing SMEs:Biomanufacturing in the next generation of industry Jeroen Hofenk,SwiftPharmaThe national landscape:Belgiums economi

43、c development through biomanufacturing Tineke Van hooland,bio.be/essenscia81 Employment:National Social Security Office-decentralised statistics(number of jobs on 30th June),excepted for 2020(estimate based on centralised statistics)-NACE21+NACE 72.11.Biomanufacturing Policy Summit 2023 Report 9Summ

44、it Discussion SessionEuropes production capacity for advanced biologicals reflects the advances now possiblewithin healthcare and also demonstrated its critical role within the COVID-19 response.Increasing biomanufacturing capacity for healthcare is a unanimously recognised need.Pharmaceutical legis

45、lation will strongly influence Europes capacity,both in the strategicdecision making within global companies and the ability of smaller companies to securesufficient investment for maturation of disruptive and high-risk innovation.It is critical thatthese legislative and regulatory frameworks enable

46、 the long-term investment into increasedcapacity across countries if patients are to benefit.From an innovation view point the speed of change continues to impress as digitalization andautomation make biomanufacturing increasingly cost effective,increasing yield and quality,andenable faster go to ma

47、rket of novel products.This would in principle translate into fasterimprovements to peoples lives and the economy.Preparedness and readiness for emerging diseases and pandemic outbreaks also become moreattainable thanks to increasingly available modular biomanufacturing capabilities.However,barriers

48、 to scaling still exist,requiring continued investment in capacity and innovativetechnological solutions.Progress in biotechnology,artificial intelligence and digitalization of processes and productdevelopment all point towards accessible improvements and cost reduction inbiomanufacturing.However,SM

49、Es,CMOs and CDMOs with strong R&D often lack the capitalexpenditure to scale,whilst larger actors assess stability and predictability of regulatoryframeworks and market access for long-term investment decisions across global regions.Theregulatory framework for biomanufacturing must become agile in o

50、rder to match the speed ofinnovation and tech transfer potential.Currently,innovators face regulatory hurdles tointegrate disruptive innovation into the healthcare space.Consistency and cooperation must be higher within trade dialogues in order to minimiseduplication of efforts across territories(pa

51、rticularly between EU and USA).Staying ahead ofnew technologies will enable regulatory bodies align globally and minimise divergence forinnovators.The ecosystem and supply network are also critical for biomanufacturing and Industry 5.0vision is central;re-skilling and upskilling of the workforce is

52、necessary to address talentshortage and insure job creation and fulfilment.Biomanufacturing Policy Summit 2023 Report Advanced healthcare:Role and growth in Europe10Summit Discussion SessionEuropes expansion of biomanufacturing,both to achieve sustainability objectives and createhigh value novel pro

53、ducts,is taking place within a rapidly changing global landscape.Biomanufacturing represents a transition to next generation manufacture and is an opportunityto attract,retain and grow businesses within Europe.Europe is lagging globally in terms of public funding and private investment.Large compani

54、esface a lack of policy alignment and poor incentives for significant investments required overdecades,whilst SMEs are agile but lack resources.The EUs competitive position must beachieved through the legislative and regulatory framework being built now and must enableemerging smaller companies and

55、global actors to achieve manufacturing focus and scale.It is apriority to set a long term target and work backwards with tangible milestones for industrialcapacity.Europe is already a preferred IP generator and testing ground,with the logical next step toensure it is a preferred production territory

56、.R&D alone is not enough to achieve this,theregulatory system must be agile and able to absorb and process innovation advances through tomarket,including alignment across regulatory boundaries.Reducing complexity across legislations,removing unintentional barriers and creating agenuinely single mark

57、et will enable impactful growth,including national variations in criticalfactors such as permitting processes.Finally,a green paradigm for regulation is needed,as thelanguage of current regulations is based on a fossil-derived past and initial legislative responsesto early biotechnologies.A reliable

58、 value chain and ecosystem is core.A skilled workforce transitioning from carbonfocused jobs is crucial and scaling bioreactor capacity to a cost-effective point is essential forEU companies.Public strategy and investment infrastructure plus development of know-howgoes hand in hand with a skilled wo

59、rkforce.Evaluating policy and legislative toolboxes in otherpriority areas such as chips and batteries will be a significant support for biomanufacturing andhelp shape the right strategy.Biomanufacturing Policy Summit 2023 Report Biomanufacturing for resilience,competitiveness,and sustainability11Eu

60、rope has been at the forefront of innovation in all areas of science and technology.It is well-recognised that great ideas and inventions only make a difference when they are implemented,and done so at scale.In the global context,visionary targets and timing of action to enable thistransfer of innov

61、ation into the market are extremely important to maintain(or recapture)aleadership position and insure the achievements of key targets for Europes economy andwellbeing of its citizens.Biomanufacturing innovation and scaling face more barriers within the EU than in other fast-growing regions.Initiati

62、ves such as public-private partnerships have been laudable in bringingplayers together,identifying hurdles and addressing them collaboratively.Europe has a strong position for biomanufacturing that can transform healthcare and createsustainable industries however this position cannot be taken for gr

63、anted.The current legislativepathways linked to Europes strategies for health,sustainability and competitiveness need toensure that all actors are able to mature.SMEs are the vehicle for innovation and more can be done to bring SMEs and larger industrialplayers together through collaboration to supp

64、ort scaling and absorption of innovation.This islinked to the ability of Europe to attract and encourage the deployment of large capitalinvestments,in addition to a positive environment for higher risk strategic R&D and go-to-market decisions on specific products.Biomanufacturing Policy Summit 2023

65、Report Europes ambition and pathway forbiomanufacturingSummit Discussion PanelModerator:Kristin Schreiber,DG GROW,European CommissionPanelists:Peter Wehrheim DG RTD,European Commission|Kristin Thompson,EUREKARENessa Fennelly,IBEC|Nicolo Giacomuzzi-Moore,CBE JU|Stefaan Fiers,Takeda Belgium12What disc

66、ussions from the Summit fit into your own work and what do you want tosee happen for Europe?What does Europe need to achieve to gain the maximum from biomanufacturing andwhat policies or strategies are going to impact this?Biomanufactured goods and therapies face unresolved challenges on the policy

67、front.Otherglobal regions are developing more fit-for-purpose regulatory frameworks and incentives,enabling the transition away from petrochemical derivation.A level playing field that addresses biomass use and carbon pricing would make market entryfairer for products and support the green transitio

68、n.This should be accompanied by continuedcollection of evidence of how biomanufactured products have a positive impact on theenvironment and the economy.European institutions recognize the important of industry for cohesion and democracy.Theseinstitutions should place biomanufacturing and biotechnol

69、ogies higher on the political agenda ifthey want to reach important targets.Europe has invested substantially in research and innovation within the biotech space overdecades.By not being ambitious and strategic now,Europe risks a decline in innovation,withaccelerated exit of intellectual property to

70、 other regions.This will result in reduced research-driven economic growth,poorer options for consumers,limits in capacity to hit strategicpolitical goals and weakened rather than strengthened resilience.Europe must decide whetherit is a pilot in the cockpit or a passenger for the delivery of innova

71、tion.Europes legislative framework is the key to enabling biomanufacturing.The pharma legislationis an example of this,as a tremendous opportunity for Europe to be recognised globally forbringing advanced innovation to patients as an originator and a destination of advancinghealthcare.The biotech in

72、dustry is by its own nature heterogeneous and fragmented.Yet a clear voice hasemerged through biomanufacturing and is further taking shape to guide policy makers towardsambitious,yet feasible frameworks in the biomanufacturing space across sectors and to thebenefit of European citizens.Biomanufactur

73、ing Policy Summit 2023 Report Europes ambition and pathway forbiomanufacturing13Biomanufacturing Policy Summit 2023 Report Biomanufacturing RecommendationsEurope needs to create a cross-sectoral biomanufacturing roadmapreflecting global positioning and targets.14Recognise cross-sectoralbiomanufactur

74、ing within highlevel European strategies,suchas EU Industrial Strategy,Pharma Strategy,BioeconomyStrategy and Green DealIndustrial Plan.Create targets for increase ofbiomanufacturing within the EUeconomy,supported by policystrategies that identify andrecognise its economic,socialand environmentalcon

75、tributions across sectors.Coordinate at a policy level thealignment between R&D focus,industrial priorities,andcommercial applicationstowards delivering sustainableproducts and processesthrough biomanufacturing.Recognise and address criticalpoints and vulnerabilitieswithin biomanufacturing valuechai

76、ns to improve Europeancompetitiveness.Address alignment acrosslegislation to addressunintentional barriers tobiomanufacturing scale up forEurope.Position regulatory frameworksand resources for productrather than process-drivencriteria to increase agility andaccelerate Europes greentransition.Recogni

77、se Europes resilienceimprovement resulting frombiomanufacturing capacity forhealthcare preparedness andsupply chain resilience acrosssectors.Support the uptake ofEuropean innovation convertedinto value-added businessesand economic developmentand incentivise investment intostart-ups and SMEs to scale

78、-up biomanufacturing withinEuropeCreate a skills pathway forbiomanufacturing andadvanced manufacturing toensure access to critical re-skilling and up-skilling in allEuropean countries.Ensure a global level playingfield for transition tosustainable biomanufacturingprocesses and products.Biomanufactur

79、ing Policy Summit 2023 Report 21st.Bio Abolis BiotechnologiesAsociacin Espaola de BioempresasBASF SEBIO DeutschlandBio.beBioPharmaChem IrelandBiotechnology InnovationOrganization(BIO)CECIMOCircular Biobased Europe JUCouncil of European BioRegionsCytivaDG AGRI,European CommissionDG GROW,European Comm

80、issionDG RTD,European Commission DSMEIT HealthEIT ManufacturingEli Lilly and CompanyEUREKAREEuropean ParliamentEvonik Operations GmbHFlanders Investment&TradeFrget Glaser&AssocisGalician Innovation AgencySummit Participant Organisations15German Association ofBiotechnology IndustriesGIP GenopoleHollandBIOIbecIFFLallemandMabDesignMerck GroupMerck Life ScienceMSDNational Institute for BioprocessingResearch and Training(NIBRT)NovartisNovo Nordisk FoundationNovozymesOECDOrgalimPfizerPuratos NVregenold GmbHRoal OySwiftPharmaTakeda BelgiumVCLS Vertex Pharmaceuticalswww.europabio.org