Watch the presentation of this webinar here: https://bit.ly/3adaxWh When implementing new automation systems, organizations must consider things like deployment time, user adoption, and costs. They must also consider the cost of doing nothing – that is, what competitive advantage is lost in standing still? What time and quality is lost in repetitive, manual tasks rather than an automated, digital workflow? What operational efficiencies are lost? In this webinar we examine how a product, process, and system agnostic automation platform can be deployed faster than traditional system specific software while bringing greater operational efficiencies (in many cases over 30% improvement). To remain competitive in the market, biopharma manufacturers must adopt automation and digital technologies, but most plants still have island of automation consisting of independently functioning, standalone unit operations. This results in operational inefficiency, regulatory concerns, and a poor understanding of the process and product life cycle. Taking the first, right step must include considering risks, costs, timelines, and technology alternatives. Traditional automation approaches tied to specific systems, processes, and products are, by their nature, limited; while an agnostic platform will address current biomanufacturing business challenges and ensure future readiness. With the right platform, a phased automation implementation can yield operational efficiency gains of up to 30% and improved product quality and regulatory compliance. In this webinar, let's explore: • Challenges of automation and digital technology adoption • What a product, process, and system agnostic platform entails • Applications and benefits of a process orchestration platform • Ensuring future readiness with process orchestration Presented by: Braj Nandan Thakur, Global Product Manager - Automation

1. The life science business of Merck KGaA,
Darmstadt, Germany operates as
MilliporeSigma in the U.S. and Canada.
Improve Operational Efficiency
by Over 30%
with Product, Process, & Systems
Agnostic Orchestration
Braj Nandan Thakur
24th May 2022

2. The Life Science business of
Merck KGaA, Darmstadt, Germany
operates as MilliporeSigma in the
U.S. and Canada.

3. Agenda
1
2
3
Automation Strategy and Technology Alternatives
What’s a Product, Process, and System Agnostics Platform?
4
5
Key Considerations for Automation in Biopharma
Process Orchestration Software Benefits
Summary

4. Choices for Automation & Digital Platform
Key considerations
4
Reduce Cost
Time to Market
Quality & Compliance
Current business challenge & future readiness
Operator-experiential
decision making
Product, Process & Systems
Oriented Automation
Product, Process & Systems
Agnostics Automation
Digital &
Automation Choice
Data-driven
decision making
Digital & Automation Platform
Plan Prepare Execute Test Release
Customized Solution OOB, Configurable & flexible
Solution
Digital &
Automation Choice
Traditional Industrial Automation Purpose built automation
Digital &
Automation Choice
BIG BANG-Project Complexity &
Managing Risk
Digital &
Automation Choice
Phased approach-Project
Complexity & Managing Risk

5. Setting the context for an agnostic automation platform
Traditional Automation Approach Shortcomings
SENSORS AND ACTUATORS/ HARDWARE
PLC/LOCAL
CONTROLS
STANDARD INDUSTRY OFFERINGS
MES
DCS/
SUPERVISORY
CONTROLS
Improve Operational Efficiency by Over 30% with Product, Process, & Systems Agnostic Orchestration | 24 May 2022
5
* DPMM – BioPhorum’s Digital Plant Maturity Model
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
Digital Transformation Journey

6. A lean approach towards automation with of connectivity, workflow,
and integration layers
Product, Process, and System Agnostic Platform
Minimize risk, maximize value, and be future ready with product and process agnostic automation platform
ERP/Planning tools
BMR
Workflow Layer
Integration layer
QC-LIMS
ERP/Planning tools
Inventory
Management
Connectivity Layer
Improve Operational Efficiency by Over 30% with Product, Process, & Systems Agnostic Orchestration | 24 May 2022
6
Plan Prepare Execute Test Release

7. Building blocks of the solution
Product, Process and System Agnostic platform
Connect Workflow Integration
Data management platform to support data-driven decision making and enable Bioprocessing 4.0
Connector library/standard protocol
provides OOB, vendor-agnostic solution
Template library permits flexible building of
product- and process-agnostic workflows
Results into batch reports, integrated data
layer to facilitate analytics, BMR execution
Improve Operational Efficiency by Over 30% with Product, Process, & Systems Agnostic Orchestration | 24 May 2022
7

8. Start simply yet effectively; realize quick value and evolve for future needs
Bio4C Orchestrator™ Software
After
Before
Plan Execute Test - Data Analysis &
Report, Review &
approval
Prepare Release
Plan Execute Test - Data
Analysis & Report,
review & approval
Prepare
Release
Managing non-value add alarm, status, monitoring, manual data capture, review and approval
would compress the batch release cycle time substantially
Improve Operational Efficiency by Over 30% with Product, Process, & Systems Agnostic Orchestration | 24 May 2022
8

9. 9
A design philosophy aligned with the BioPhorum's Technology Roadmap
Lean and Agile
Digital Platform
Extendibility
STANDARD
EASE OF USE
FLEXIBILITY
MODULARITY
INTER-
OPERABILITY
FUTURE
READINESS
?
?
?
Continuous
BATCH
Designed considering next generation of bioprocessing
A Better Approach for Bioprocessing

10. SENSORS AND ACTUATORS/
HARDWARE
PLC/LOCAL
CONTROLS
Bio4C Orchestrator™
3rd PARTY Systems
connectivity
Remote
Support
Reporting
User Management
Process Trend-Monitoring &
Visualization
Data Storage &
back up
Recipe
Management
Advanced
Analytics
STANDARD INDUSTRY OFFERINGS
DCS/
SUPERVISORY
CONTROLS
MES
Bio4C Orchestrator™ Software
Where Bio4C Orchestrator™ Software fits within industry offerings
10
FOCUS ON BIOMANUFACTURING OPERATIONAL NEEDS
Bio4C Orchestrator™ Software

11. Realize value in < 3 months
Bio4C Orchestrator™ Software
Title of Presentation | DD.MM.YYYY
11
Advance your bioprocessing operations from Islands of Automation to a Connected Plant
1
2
3
4
6
5
Bio4C
Orches-
trator
Modern, Modular, Flexible
Connectivity Ecosystem
Process/Plant
Data Layer
Effective Data Management
Operational
Capabilities
Centralized Monitoring
& Visualization

12. 12
Process Monitoring
 Equipment information
 Systems status
 Easily connect and disconnect
 Alarm status
 Recipe run status
Enhanced visibility, collaboration and timely action
Monitor systems in multiple remote locations

13. 13
Process Monitoring
Live trending for all connected systems
Live trending of any system
 Select and monitor specific
parameters from a system
 Create user preferred views
 Compare and overlay trends
across connected skids

14. Recipe generation
Recipe Management
Dispatch recipes for multiple UoPs
14
 Create recipes, reuse,
collaborate
 Create recipes faster; error-
proof
• Manage by role: flexible,
handles complexity
• Supports recipe validation

15. Reporting
15
Content rich reports
Centralized reporting simplifies data gathering
 Batch and time-based reporting
 Configurable report templates
 Full audit trails
 Report approvals with E-
signatures
 Reports include
 Pre runs setpoints
 Manual event report
 Alarm event report
 Security report
 Recipe step reports
 Trends configuration
included in reports

16. 16
User Management
Remotely manage roles and permissions from a central dashboard
Significantly reduces time & effort to manage users in the
connected plant
• Administrator can assign and
unassign roles
• Users are synced to the Systems
• Users can be de-activated
• Supports User Catalog/Active
Directory Integration
• Can Create and Manage Custom
roles and Permissions

17. M Lab™ Global Rollout with 7 sites across the globe
Bio4C™ Orchestrator™ Software
Improve Operational Efficiency by Over 30% with Product, Process, & Systems Agnostic Orchestration | 24 May 2022
17

18. Bio4C Orchestrator™ Software
18
Data Sheet
ROI Calculator
Web Site
White Papers
Demo Video

19. Thanks !
Improve Operational Efficiency by Over 30% with Product, Process, & Systems Agnostic Orchestration | 24 May 2022
19

20. The vibrant M, Millipore, MilliporeSigma, Orchestrator, and Bio4C, 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.
© 2022 Merck KGaA, Darmstadt, Germany and/or its affiliates. All Rights Reserved.