重塑生物制药：从实验室到生产线

Fueling smarter, faster andscalable biopharma productionwith intelligent technologies Authors Hagen SpäthLife Sciences Industry XEMEA Lead Anne Marie O’HalloranLife Sciences Supply Chain &Operations, Americas Lead Selen Karaca-GriffinProducts and Life Sciences ThoughtLeadership, Accenture Research Selen is Accenture’s Research Lead for Products andLife Sciences globally, where she oversees a team of30+ researchers. She shapes the industry’s thoughtleadership agenda, driving insights on scientificinnovation, the convergence of science and technology,and market disruptions redefining the future of industries.Selen brings deep experience across both strategyconsulting and research leadership. In her current role,she develops CEO perspectives and curates Accenture’sannual Life Sciences CEO Forum, engaging industry leaderson the most pressing issues of the future. Prior to consulting,Selen worked as a scientist and process development engineerat leading biopharmaceutical companies, where she focusedon cell line development and bioprocess design. Based inBoston, Massachusetts, she also serves on the BiotechnologyIndustrial Advisory Board at Northeastern University. Anne Marie brings over 25 years of experience guidingglobal pharmaceutical biotechnology, and medicaltechnology companies through complex operationalchange. As Accenture’s Americas Lead for Life SciencesSupply Chain and Operations and Industry X practice,Anne Marie oversees a diverse portfolio of clientengagements focused on digital transformation,operational resilience and patient-centric innovation.Her leadership spans the full value chain, from strategythrough execution, across domains such as integratedplanning, manufacturing and logistics. Anne Marie isa key contributor to Accenture’s thought leadership inlife sciences, shaping industry perspectives on topicssuch as digital manufacturing to contract manufacturingorganization collaboration and autonomous supply chain. Hagen is a Managing Director responsible forAccenture’s Industry X Life Sciences offering inEMEA. He has approximately 25 years of experiencein manufacturing, with a specific focus on largebiopharma manufacturing for the past 12 years.Hagen has led numerous high-profile projectsfor large biopharma companies, including IT/OTpartnerships, clinical study control towers anddigital therapeutics development. He helps clientsachieve flexibility and operational excellence throughdigital transformation in the life sciences sector. Contributors BPHughes CMC Consulting The authors would like to thank Amanda Rubin, Bilal Butt,Camille Planty, Ciara Mc Nally, Joanna Lisiecka,Kamila Ochedalska-Szymanska and Kristina Tomesfor their contributions Former Accenture Life Sciences Industry Xand Supply Chain & Operations, Global Lead About the research Scope This report focuses on biopharmaceuticalmanufacturing and supporting technicaloperations functions, including processdevelopment, chemistry, manufacturingand controls (CMC) and manufacturingscience and technology (MS&T). Throughout the report we will usethe terms “manufacturing” and“technical operations” interchangeablyto refer to the functional landscape. The term “intelligent technologies”is used to describe digital solutionssuch as advanced data analytics, AI,generative AI, agentic AI, digital twins,automation and robotics. Table of contents 10The roadblocks onthe way to scaledigital initiatives 06Biopharmaceuticalmanufacturingstands at a criticalinflection point 32Future of biopharmaproduction isdriven by intelligenttechnologies 11Reinventingthe productdevelopmentlifecycle withintelligenttechnologies 08Current state:Progress amidpersistentchallenges 15 A roadmap forunlocking thevalue of intelligenttechnologies intechnicaloperations Executivesummary Manufacturing is now on the critical path to deliveringessential medicines to patients, a pivotal moment thatdemands tighter integration from lab to line to ensurespeed, reliability, and quality. Complex biologicspipelines, AI-accelerated R&D and mountinggeopolitical and economic pressures have catapultedmanufacturing to a top priority, and with good reason—64% of drug-launch delays in 2024 stemmed fromchemistry, manufacturing and control issues.1 with digital innovation confined to isolated initiatives.Even among companies achieving high digitalmaturity levels, certain teams operate with advancedcapabilities while others still depend on legacy toolsand manual workflows. With so many levers yet to bepulled, there is significant untapped value in morebroadly embedding intelligent technologies acrosstechnical operations. By scaling intelligenttechnologies across the productlifecycle—from robotic high-throughput process designto AI-augmented real-timeanalytics and decision making—biopharma leaders can reducecosts, accelerate launches andbuild more reliable, adaptivemanufacturing systems. What should biopharma companies do to realizethe full potential of intelligent technologies?