數位生物製造的進步：技術增長機會

本報告探討了數位化生物製造，並對生物製造的數位化進程和技術進步進行了分析。

內容

戰略要務

• 為什麼越來越難成長？
• 戰略要務 8 (TM)
• 三大戰略要務對數位生物製造行業的影響
• 增長機會推動增長 Pipeline Engine(TM)
• 調查方法

成長環境分析

• 分析範圍
• 細分
• 增長動力
• 抑制增長的因素

數位化生物製造技術評價

• 引入數位生物製造的好處
• 遷移到擁有成熟數位設備的生物製造單位
• 無縫數位生物製造的技術融合
• 數位化提高了生物產品的質量和數量
• 數位生物製造在治療開發中的應用
• 區塊鏈
• 人工智能/機器學習
• 數位孿生
• 自動化和機器人技術
• 物聯網和雲

過程控制和優化

• 數據驅動的過程控制和優化
• 在上游流程中廣泛採用細胞培養自動化和優化
• 下游工藝向連續生物製造的過渡
• 行業利益相關者優化上下游流程以實現順利轉型

過程分析和監控

• 生物製造數據的高級分析
• 用於監控生物製造的高級分析系統
• 用於實時產品質量檢查的數位分析工具的進步
• 高級過程分析的新方法
• 引領生物製造的預測方法

工廠運作

• 實現高效工廠成果和應對運營挑戰的數位解決方案
• 轉型為成熟的數位化工廠運營系統
• 一家以數位方式改進整個製造業務的公司
• CDMO 與生物製藥公司合作加速生物製造的數位化

供應鏈

• 改善供應鏈的數位解決方案
• 數位供應鏈提高了透明度和交互性
• 區塊鍊為供應鏈創建安全且覆蓋面廣的網絡
• 未來展望

採用和實施數位工具

• 鼓勵為引進數位生物製造籌款活動
• 合作實現數位化生物製造
• 基於數位生物製造能力的公司分類
• 要點

增長機會領域

• 增長機會 1：採用數位孿生
• 增長機會 2：嵌入預測分析
• 增長機會 3：有針對性的收購

下一步

Digital Technologies Driving Transformational Growth Across the Biomanufacturing Value Chain

Digitalization of the entire value chain will drive next-generation biomanufacturing. The industry is all set to move away from the traditional pen-and-paper-based process to a more advanced, digitized, track-and-trace process that is aligned toward Industry 4.0. Digital tools applied across processes, monitoring, analytics, and operations have accelerated biomanufacturing with a data-driven approach. Digital biomanufacturing can streamline processes and assist with optimal use of resources.

Scalability and reproducibility are some of the crucial challenges in biomanufacturing, especially in the production of biologics, and cell and gene therapies, or viral vector manufacturing. Digitalization is enabling a sustainable, effective, cost-efficient, time-efficient, and error-free system for biomanufacturing.

IoT, automation/robotics, AI/machine learning, Digital Twins, and Blockchain have been deployed in various digital biomanufacturing processes, thereby ensuring a seamless and uninterrupted workflow. Digitalization enables the best control and optimization of starting materials; in upstream processes, it helps with cell culture and media optimization; for downstream processes, it helps select the best strategy for purification and impurity removal. Digital tools are also making best use of the historical biomanufacturing data to improve/optimize processes. Advanced sensors and cutting-edge software collect real-time data, which offers a complete picture of the bioreactor's condition.

Advanced analytics helps users understand variations in data and predict the most suitable conditions for biomanufacturing of therapeutics. Digital tools and powerful software platforms empower scientists and engineers and help them offer better-quality, sustainable products to patients faster and at a lower cost.

The report analyzes the progress that the biomanufacturing industry has made in terms of digitalization and how the industry embraces technological advancement to lower biomanufacturing footprint and overcome the limitations of traditional methods.

Table of Contents

Strategic Imperatives

• Why Is It Increasingly Difficult to Grow?The Strategic Imperative 8™: Factors Creating Pressure on Digital Biomanufacturing Growth
• The Strategic Imperative 8™
• The Impact of the Top 3 Strategic Imperatives on the Digital Biomanufacturing Industry
• Growth Opportunities Fuel the Growth Pipeline Engine™
• Research Methodology

Growth Environment Analysis

• Scope of Analysis
• Segmentation
• Growth Drivers
• Growth Restraints

Assessment of Digital Biomanufacturing Technologies

• Benefits of Deploying Digital Biomanufacturing
• Shift Toward a Full- Fledged Digitally Equipped Biomanufacturing Unit
• Technology Convergence for Seamless Digital Biomanufacturing
• Digitalization Increases Bioproduct Quality and Quantity
• Application of Digital Biomanufacturing in Developing Therapeutics
• Blockchain
• AI/ML
• Digital Twin
• Automation & Robotics
• IoT and Cloud

Process Control/Optimization

• Data-driven Process Control and Optimization
• Wide Adoption of Cell Culture Automation and Optimization in Upstream Process
• Shift Toward Continuous Biomanufacturing for Downstream Processes
• Industry Stakeholders Optimizing Upstream and Downstream Processes for a Smooth Transformation

Process Analytics & Monitoring

• Advanced Analytics for Biomanufacturing Data
• Advanced Analytical System to Monitor Biomanufacturing
• Advancements in Digital Analytical Tools for Real-Time Product Quality Check
• New Approaches in Advanced Process Analytics
• Predictive Approaches to Lead the Way Forward for Biomanufacturing

Factory Operations

• Digital Solution to Enable Efficient Factory Outcomes and Operational Challenges
• Transformation to a Full-Fledged Digital Factory Operation Systems
• Companies Improving the Entire Manufacturing Operations Digitally
• Collaboration between CDMOs and Biopharmas to Increase Digitization of Biomanufacturing

Supply Chain

• Digital Solution to Improve Supply Chain
• Digital Supply Chain Increases Transparency and Interaction
• Blockchain Creating Safe and Well-covered Network for Supply Chain
• The Path Ahead

Adoption and Implementation of Digital Tools

• Encouraging Funding Activities for the Adoption of Digital Biomanufacturing
• Collaborations for Implementation of Digital Biomanufacturing
• Collaborations for Implementation of Digital Biomanufacturing (continued)
• Company Categorization Based on Digital Biomanufacturing Capabilities
• Key Takeaways

Growth Opportunity Universe

• Growth Opportunity 1: Adoption of Digital Twins
• Growth Opportunity 1: Adoption of Digital Twins (continued)
• Growth Opportunity 2: Incorporation of Predictive Analytics
• Growth Opportunity 2: Incorporation of Predictive Analytics (continued)
• Growth Opportunity 3: Targeted Acquisitions
• Growth Opportunity 3: Targeted Acquisitions of Digital Technology Developers by CDMOs (continued)

Next Steps

• Your Next Steps
• Why Frost, Why Now?
• Legal Disclaimer