重塑生物制药：从实验室到生产线

Fueling smarter, faster andscalable biopharma production Authors Anne Marie O’HalloranLife Sciences Supply Chain &Operations, Americas Lead Hagen SpäthLife Sciences Industry XEMEA Lead Selen Karaca-GriffinProducts and Life Sciences Thought 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. 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 client 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. Contributors BPHughes CMC Consulting Former Accenture Life Sciences Industry Xand Supply Chain & Operations, Global Lead The authors would like to thank Amanda Rubin, Bilal Butt,Camille Planty, Ciara Mc Nally, Joanna Lisiecka,Kamila Ochedalska-Szymanska and Kristina Tomes About the research Scope This report focuses on biopharmaceuticalmanufacturing and supporting technicaloperations functions, including process Throughout the report we will usethe terms “manufacturing” and The term “intelligent technologies”is used to describe digital solutionssuch as advanced data analytics, AI, Table of contents 32Future of biopharmaproduction is 06Biopharmaceuticalmanufacturing 10The roadblocks on 15A roadmap forunlocking thevalue of intelligent 08Current state:Progress amid 11Reinventingthe productdevelopmentlifecycle with 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 biologics with digital innovation confined to isolated initiatives.Even among companies achieving high digitalmaturity levels, certain teams operate with advanced By scaling intelligenttechnologies across the productlifecycle—from robotic high-throughput process designto AI-augmented real-time What should biopharma companies do to realizethe full potential of intelligent technologies?Building on our experience delivering over 2,000projects across industries, this research provides A new generation of integrated digital ecosystems,powered by advanced analytics, AI, digital twins,intelligent agents and robotics, promise to transformbiopharma manufacturing and process development. Data, AI and other intelligent technologies are alreadyrewriting the rules across the industry. As thesecapabilities advance, manufacturing has the potential Although28% of our global survey respondents fromtop biopharma companies already have access to Biopharmaceutical manufacturingstands at a critical inflection point As the complexity of modalities in drug pipelinesincreases and AI-accelerated R&D compressesdevelopment timelines, manufacturing has steppedinto the spotlight. Once a behind-the-scenes function, Broader external challenges, including geopoliticaland economic volatility, supply chain disruptions, These dynamics are reshaping what it takes tosucceed in manufacturing. Teams must make their The urgency for change is clear. Our analysis ofFDA Complete Response Letters (CRLs) issued totop pharmaceutical companies between 2009and 2024 shows that last year was unprecedented: The pressure on manufacturing and technicaloperations continues to mount, driven by three over half (64%) of market delays were due to chemistry, Increasing molecular complexity, with biologics AI-driven acceleration of drug discovery andclinical trials, which demands that process We won't be able to optimize thecost of goods unless we digitalize.So suddenly, this becomes R&D’sproblem and commercial’s problem The key to building resilience to potential disruptions impacting pharmaceutical manufacturing lies inharnessing the power of data and intelligent technologies. In an era where data itself is a strategic asset,improving data connectivity and applying advanced analytics, AI, process twins, robotics and AI agents For executives, the stakes could not be higher. Our research found that companies modernizing •Accelerated time-to-market in an increasingly competitive landscape.•Significantly lower production costs. Head of Digital & AI TransformationTop 20 large biopharma company The current state: Progressamid persistent challenges Our research indicates that the pharmaceutical sector is at a pivotal juncturein its digital transformation journey. A new wave of advanced analytics and In our global survey,5a s