Better Bioprocessing Efficiency Through Centralized Orchestration
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Merck KGaA's life science business, operating as MilliporeSigma in the U.S. and Canada, focuses on enhancing bioprocessing efficiency through solutions like the Bio4C™ orchestrator. This platform aims to streamline biomanufacturing by offering centralized monitoring, reduced manual intervention, and compliance with regulatory standards, ultimately enhancing production speed, quality, and cost-effectiveness. It addresses the evolving needs of biopharma manufacturers amidst trends toward modular and continuous manufacturing.
Better Bioprocessing Efficiency Through Centralized Orchestration
- 1. The life science business of Merck KGaA, Darmstadt, Germany operates as MilliporeSigma in the U.S. and Canada. Aniruddha Bose Global Product Manager 13 May 2021 Better Bioprocessing efficiency through Centralized Orchestration
- 2. The life science business of Merck KGaA, Darmstadt, Germany operates as MilliporeSigma in the U.S. and Canada
- 3. Agenda 1 2 3 Digital Plant Maturity Model Biomanufacturing Landscape Gaps in Custom Automation Solutions 4 Innovations in Bio4C™ Orchestrator 5 Use Cases Value Creation Q&A
- 5. 5 Industry 4.0 First Generation Automation Industry 4.0 Impact Heavy capital investments Reverse Engineered – Based on use cases Value-driven/value enhancement decisions Longer deployment cycles Faster/Shorter deployment cycles Speed in Concept to Go live Heavily dependent on System integrators Empower users directly Solution focussed/ problem solving approach Inflexible reprogramming Flexibility and agility Big focus on software solutions - incrementally Difficult to replicate and scale Easy to replicate and scale Shorter delivery cycles Reference: Wikipedia web 1st 2nd 3rd 4th Mechanization waterpower, steam power Mass production, assembly line, electricity Computer and automation Cyber Physical Systems
- 6. Bioprocessing 4.0 & the Digital Plant Maturity Model (DPMM) 6 Biopharma Is on Evolutionary Journey to the Facility of the Future BioContinuum™ Platform Scope Process Analytical Technologies (PAT) Digital Technologies & Data Management Process Technologies Maturity level and its capabilities Business Drivers Speed Reduce new facility build times by 70%. Compress production lead time by 80%. Quality 10X robustness. 90% reduction in cost of poor quality. Flexibility Reduce product change-over time by 90%. Cost 90% reduction in cost to manufacture and CAPEX. Market Trends Market Growth Uncertainty New Product Classes Cost Pressure Pre-Digital Plant ✓ Paper-Based ✓ Manual processes ✓ Isolated Unit operations Digital Siloes ✓ Islands of automation ✓ Recipes on systems ✓ Offline analytics Connected Plant/ Predictive Plant ✓ Vertically integrated systems ✓ Automated data analytics ✓ Processing Modeling & Monitoring Fully Digital Adaptive ✓ Predictive analytics ✓ “Plug and Play” Automation ✓ Continuous process verification Reference: BioPhorum (BPOG)
- 7. BioContinuum™ Platform Scope Process Analytical Technologies Digital Technologies & Data Management Process Technologies Defining Capabilities Maturity level Pre-Digital Plant ✓ Paper-Based ✓ Manual processes ✓ Isolated Unit operations Digital Siloes ✓ Islands of automation ✓ Recipes on systems ✓ Offline analytics Connected Plant/ Predictive Plant ✓ Vertically integrated systems ✓ Automated data analytics ✓ Processing Modeling & Monitoring Fully Digital Adaptive ✓ Predictive analytics ✓ “Plug and Play” Automation ✓ Continuous process verification Flexible platform and modules expand digital capabilities 7 Bio4C™ Orchestrator Helps Biopharma Manufacturers Bio4C Suite™ Orchestrator Essentials Bio4C™ Orchestrator software, part of Bio4C Suite™ Advanced Analytics Module EBR Module Workflow Management Module MES We see this solution working for the mAb world and are thinking about the 5-year future with semi-continuous processes, getting unit operations to talk together and pushing for automation. - Multinational Biopharma Manufacturer The universal digital platform. The Biopharma all-in-one! This is crossing many boundaries in the industry today! -European CDMO Reference: BioPhorum (BPOG)
- 9. - Accelerates commercial production by scaling up easily over time - CAPEX can be spread out over large number of years - Real-time data coupled with manufacturing context addresses issues before the batch moves to next step and allows adjustments in real time - Single use equipment – reduce CAPEX, minimize supply chain challenges, reduce energy and water consumption Bio4C™ Orchestrator | 13.05.2021 9 The Biomanufacturing Landscape Modular manufacturing Reference: Contract Pharma “The Manufacturing Revolution In Medicine” May 2019
- 10. - Allows non-stop production within same facility – integrated production line backed by real-time operational data - Eliminates hold times between batches and mitigates risks with storing critical raw materials - Seamless process integration and utmost control needed – operational data and automation plays a key role here Bio4C™ Orchestrator | 13.05.2021 10 The Biomanufacturing Landscape Continuous manufacturing Reference: Contract Pharma “The Manufacturing Revolution In Medicine” May 2019
- 11. - Involves batches of materials specific to an individual patient - Manufacturers produce very small volume each time – sub litres - Modular manufacturing scaled down in size and volume - Lower production foot print Bio4C™ Orchestrator | 13.05.2021 11 The Biomanufacturing Landscape Personalized medicine Reference: Contract Pharma “The Manufacturing Revolution In Medicine” May 2019
- 12. Deliver Performance Fast and easy to deploy Highly scalable Towards automation solutions Critical Aspects in Biomanufacturing Facility 12
- 13. GAPS IN CUSTOM SOLUTIONS
- 14. 18 months Keeping up with the pace? 14 Starting from a ‘blank page’
- 17. 17 Introducing Bio4C™ Orchestrator • Bio4C™ Orchestrator software connects to unit operations from a centralized “orchestration layer” for complete visibility, monitoring, and management of regulatory-compliant biomanufacturing systems and processes. • Browser-based, Bio4C™ Orchestrator provides easy, remote access to systems, recipes, reports, user accounts and alarms from a holistic process dashboard. • Monitor and visualize your bioprocesses from anywhere –you don’t need to be on the plant floor to check your production run.
- 18. 18 What Makes Bio4C™ Orchestrator Unique? Solutions in biopharma manufacturing: reduced manual intervention, better compliance and reliable automation. SENSORS AND ACTUATORS/ HARDWARE PLC/LOCAL CONTROLS Bio4C™ Orchestrator PLATFORM 3rd PARTY Systems connectivity REMOTE SUPPORT Workflow Modules Plug & Play Inventory Management Electronic Batch Records Enterprise Applications Advanced Analytics STANDARD INDUSTRY OFFERINGS This is in between MES & DCS, e.g., a standard MES would have 14 modules that are for general manufacturing, We will only develop what is required for Biopharma. DCS/ SUPERVISORY CONTROLS MES OUR COMPANY’S OFFERINGS R1 AND BEYOND
- 19. Flexibility & Modularity 19 Flexible Solution Lowering Entry Barrier Facility Automation Pyramid SENSORS AND ACTUATORS/ HARDWARE PLC/LOCAL CONTROLS DCS/ SUPER- VISORY CONTROLS MES One Bio4C™ Software Suite can adapt to different typologies of customers in a solution-centric approach driven by a customer success strategy as opposed to standard product offering. Solution software by design Bio4C™ ProcessPad DCS Bio4C™ Orchestrator Bio4C™ ProcessPad Bio4C™ Orchestrator Collect Bio4C™ ProcessPad MES Connect Bio4C™ Orchestrator DCS Control Flexibility modularity Manufacturing site type A Manufacturing site type B Manufacturing site type C
- 20. USE CASES
- 21. Bio4C™ Orchestrator 21 Managing Passwords and Users Efficiently 6 HMIs to Login 10 Operators in the manufacturing facility 60 User creations 60*4 Roles assigns and management Bio4C™ Orchestrator manages the workflow • Singlehandedly • Remotely • Enhances monitoring experience w.r.t role allocations • Administrator can seamlessly assign and un-assign roles to users • Future User Catalogue / AD support Sterile filtration Virus removal Cell culture Harvest Chromatography Clarification Tangential flow filtration Formulation & Final Fill
- 22. Bio4C™ Orchestrator 22 Managing Unit Op Reports and Batch Reports Centrally • Audit trails reports • Run reports • Batch reporting • Send for Prints from individual PCs connected to Bioprocess equipment • Actions * 6 SKIDs • Same or Different locations • Gown up/Gown down time • US and DS end times not precisely predictable Bio4C™ Orchestrator manages the Reporting workflow • Remote access for all 6 SKIDs • No physical connection or presence needed • Batch reporting for USP DSP process runs • Intuitive UI • Secure connection • Seamless approval process • No need to walk to HMI for Reports Sterile filtration Virus removal Cell culture Harvest Chromatography Clarification Tangential flow filtration Formulation & Final Fill
- 23. People Lack of subject matter experts – knowledge of both IT and bioprocess Skill gaps Operational Not focusing on value added actions/operations – focus on repeat actions Change management and user adoption Lack of scaling plant Financial Technology led, not value led Lack of clarity to: P&L impact & ROI Digital Infrastructure Scalable architecture Last level of connectivity IT/OT convergence strategy 23 Why do digital enablement pilots get stuck? Managing Scalability in Digital Enablement
- 24. Flexible platform and modules expand digital capabilities 24 Bio4C™ Orchestrator Offers Scalability in Digital Enablement Add-On Modules in future Bio4C™ Orchestrator Essentials • Process dashboard • Recipe management • Run reports • Data storage • User management • CCP® Skids Connectivity • Regulatory Compliance
- 25. Bio4C™ Orchestrator | 13.05.2021 25 Seamless Tech Transfers Process Development Sterile filtration Virus removal Cell culture Harvest Chromatography Clarification Tangential flow filtration Formulation & Final Fill Pilot lab Clinical or Commercial manufacturing Two sites at a Commercial scale Sponsor organization and a CMO at a manufacturing scale
- 26. 26 Seamless Site Expansions • CoPrime® Biochromatography Systems • Mobius® Smart Chromatography • Mobius® Smart TFF • Mobius® Single-use Bioreactors • New hardware expansion in later years 3X 2X 1X 3X 2022 4X 2021
- 27. 27 Bio4C™ Orchestrator DI Assessment
- 28. 28 Bio4C™ Orchestrator 21CFR Part 11 Compliance
- 30. Bio4C™ Orchestrator Live Launch – Oct 2020 Bio4C™ Orchestrator Deployment in 2021 Bio4C™ Orchestrator @ M LabTM Collaboration Centers
- 31. 31 Value Drivers - Bio4C™ Orchestrator Less manual intervention, better compliance & reliable automation Modular Automation solutions Solution caters to Multiple Molecules in production batches Vendor agnostic enhanced connectivity across Biomanufacturing SKIDS 21 CFR Part 11 and EudraLex Vol. 4 Annex 11 compliance Process Dev. & Facility Conceptual Design Planning & development Design & procure Construct & validate Operate and Maintain Upgrade / Refurbish DEPLOY EMBED OPTIMIZE …a cost-effective solution faster …bioprocess specific automation solutions …our users’ CAPEX today and grow as per their needs Our Value Delivery Speed Quality Flexibility Cost User Expectations
- 32. The vibrant M, are trademarks of Merck KGaA, Darmstadt, Germany or its affiliates. All other trademarks are the property of their respective owners. Detailed information on trademarks is available via publicly accessible resources. © 2021 Merck KGaA, Darmstadt, Germany and/or its affiliates. All Rights Reserved. Global Product Manager Bangalore, India aniruddha.bose@emdgroup.com ANIRUDDHA BOSE
- 33. 33 Q&A Data Sheet White Papers Demo Video Website