Watch this webinar here: https://bit.ly/2ZpV3GU Biopharmaceutical processes are complex and highly variable in nature. This can result in inconsistent and unpredictable process outcomes. To manage complexity and better understand causes of variability, in-depth knowledge and thorough understanding of the process is critical. Bio4C™ ProcessPad provides the data integration, analysis and sharing across the manufacturing network and end-to-end data management throughout the process lifecycle required for continued process verification, reporting, and analytics. Bio4C™ ProcessPad is a data visualization, analytics, and process monitoring platform that enables bioprocess lifecycle management, reporting, investigations, and continued process verification (CPV). Intelligently combining process data from batches, Enterprise Resource Planning (ERP), Manufacturing Execution System (MES), Laboratory Information Management System (LIMS), Historian, process equipment, and manual sources into a single, validated data source, Bio4C™ ProcessPad ensures data is current, complete, and contextual throughout the product lifecycle. In this webinar, you will learn: • Introduction to Next Generation BioContinuum™ Digital Platform and Bio4C™ Software Suite • Overview of Bioprocess lifecycle and present biomanufacturing data management challenges • Introduction to the Bio4C™ ProcessPad digital platform and its modules and features • Benefits of Bio4C™ ProcessPad in investigations, process monitoring, continued process verification (CPV) and CDMO operations

1. The life science business of Merck KGaA,
Darmstadt, Germany operates
as MilliporeSigma in the U.S. and Canada.
Next-Generation Bioprocess Monitoring to Enable Smart
Data Management and Analysis
Hemant Garg
Product Manager, Analytics

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

3. Agenda
1
2 Bioprocessing Data Landscape – Current Challenges and
Needs
Data Management Approaches and Solutions-
Introduction of Bio4CTM ProcessPad
Next Gen Bioprocessing and the BioContinuum™ Platform
3
4
Applications and Use Cases for Bio4CTM
ProcessPad

4. Next Gen Bioprocessing and the
BioContinuum™ Platform

5. 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.
Business
Drivers
Market
Growth
Uncertainty
New Product
Classes
Cost
Pressure
Market
Trends
How do we react to meet the demands of
today and the future?
* Source: BioPhorum (BPOG)
https://www.biophorum.com/category/resources/technology-roadmapping-resources/introduction/
BioContinuum™
Platform Scope
Process
Analytical
Technologies
Digital
Technologies &
Data Management
Intensified
Processing

6. Bio4C™ Software Suite
Specifically conceived by industry experts for bioprocess
professionals, the Bio4C™ Software Suite is comprised of
stand-alone, but seamlessly compatible software products.
Their intuitive interfaces and easy access enable a broad
user base to collaborate with global teams across
geographies and organizational silos to control, monitor
and analyse equipment, processes, results, and data in
near real-time.
Based on our core 4C’s: Control, Connect, Collect,
Collaborate, the Bio4C™ Suite offers a convergent, open
digital environment, adaptable to your changing
productivity, process, and regulatory needs.
The Bio4C™ Suite allows for data transparency
and manufacturing intelligence leading to quick
and efficient data-driven decisions for mastery at
the process and plant level.

7. Addressing customers’ digital transformation needs
Bio4C™ Software Suite
Control
Next generation platform for control
and management of unit operations
Connect
Designed to connect across
the process continuum
Collaborate
Complementary capabilities for collaboration,
remote support and cloud services
Collect
Data collection and advanced analytics
capabilities for rapid process insights

8. Bioprocessing Data Landscape:
Current Challenges and Needs

9. Bioprocess Lifecycle
Core functions create and consume data across the process life cycle

10. Data captured by disparate systems
Bioprocess Data Landscape
Data Stores
MES
LES
eLN
eBR
Custom DB
Data
Warehouse
Data
Historians
QualityControland
Assurance
QA Batch Fitness For Release
Change Control
Management
Process Test Samples
QC Methods
Results
People FitnessTraining
Management
Corrective Action
Management
Corrective Action
Management
Engineering
Equipment Fitness
Maintenance Record
Work Order
LMS – Learning Management System, LIMS – Laboratory Information Management System, QMS –Quality Management
System, BMS - Building Management System, MES – Manufacturing Execution System, LES – Laboratory Execution system,
Asset Mgmt. – Asset Management
Process
Development
Process Fitness
Development Reports
Process Development Experiments
Process
Execution
Process Excursions
and events
Manufacturing
Facility Management
Non-conformance
Management
Environment Fitness
Process Data Batch Report
Investigation Report
eLN
Asset
Mgmt. BMS
eBR
QMS
LMS
LIMS

11. Data Needs for Investigations and Monitoring
• Integration of data collected from
various work processes
• Paper-based, manual systems
• Other electronic systems
• Process execution workflows
• Process development
• Quality Control and Assurance
• Commercial manufacturing
• Engineering
Engineering
Manufacturing
Investigation
Report
Process Fitness
Experimental Data
Process
Development
Change Control
Management
Test Results
People FitnessTraining
Management
QualityControland
Assurance
Facility Management
Process Data Batch Report
Investigation
Report
Equipment Fitness
Work Order

12. Regulatory Expectations for Bioprocess Monitoring and Control
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/process-validation-general-principles-and-practices
https://www.ich.org/page/quality-guidelines
Pharmaceutical companies should plan and execute a system for the
monitoring of process performance and product quality to ensure
a state of control is maintained
-ICH Q10
An ongoing program to collect and analyze product and process data
that relate to product quality must be established. The data collected should
include relevant process trends and quality of incoming materials or
components, in-process material, and finished products.
-FDA Process Validation Guidance, Jan 2011

13. Data Management
Approaches and Solutions:
Introduction to Bio4C™
ProcessPad

14. Bio4C™ ProcessPad Software
A browser-based platform for data acquisition,
aggregation and process analytics. Built by bioprocess
engineers to manage and analyze your disjoined and
complex process information for a deeper understanding of
your biopharma processes across the process and product
lifecycle in near real-time.
Master your bioprocess
through profound data insights

15. Through data aggregation, management, visualizations, and analysis,
Bio4C™ ProcessPad makes all critical bioprocess data readily available.
Easy on-demand access to biopharma manufacturing data
Browser-based Platform

16. Toolset for Efficient Process Troubleshooting

17. How Bio4CTM ProcessPad Software Helps
Data Archival
Process Monitoring
And Data Analysis
Reporting
and Sharing
Process
Capability
Statistical
Process
Control
1
2
3
Bio4C™ ProcessPad DBProcess Historians

18. How Bio4CTM ProcessPad Software Helps
Through data aggregation, management, visualizations, and analysis,
Bio4C™ ProcessPad makes all critical bioprocess data readily available.
Process lifecycle management
 Capture all development, scale-up, and commercial data
on one platform
 Simplify tech transfer process
 Access to the latest version of process map
Reporting
 Generate process summary reports
 Create ad-hoc reports required in root cause investigations
 Batch excursion reports, equipment utilization
Continued Process Verification and analytics
 Aggregate real-time and offline process data
 Statistical process control (SPC) and process capability
 Preconfigured trending rules to aid process monitoring
 Process analysis tools to aid investigations & process troubleshooting
 Control limits management

19. Bio4CTM ProcessPad Software Modules
Trending, Reporting, and Analytics of Machine Data
• Bioreactors
• Chromatography Systems
• CIP Skids
• Buffer Systems
Capture, Trending, Analysis and Reporting of Offline Data
• Offline Batch/Run Data
• Analytical Test Results Data
• SQC, Out-of-trend and Continued Process Verification
Capture, Trending, Analysis and Reporting of Stability
data
• Profile Trending
• Reporting
• Shelf-life prediction
ProcessPad RT
ProcessPad
offline
ProcessPad
stab
Our Software Reliance Program support is provided with all Bio4C™ ProcessPad modules.

20. Bio4CTM ProcessPad Software Benefits to Customers
• Significant time savings on data hunting & gathering, aggregation, and reporting
• Global teams, CMOs, and suppliers can have browser-based access to data, analytics, and
visualizations
• Single, validated source of data for analytics and process troubleshooting
INDIRECT Benefits
DIRECT Benefits
• Faster closure of investigations & meeting quality metrics
• Faster release of quarantined lots
• Ensure robust supply chain of drugs to patients
• Ensure product consistency and quality compliance

21. Applications and Use Cases for
Bio4C™ ProcessPad

22. Common Applications for Bio4C™ ProcessPad
22
Continued Process
Verification
CDMO data
Management
Investigations Process monitoring

23. Use Case: Continued Process Verification (CPV)
Disparate Data
Sources
Scalability &
Usability
Trust in
Data
Real-time SPC*
Monitoring
Control Limits
Management
Process Summary
Reports
Data assembly and integration
from all sources
Quick deployment and
configuration, easy to learn
Facilitates 21 CFR Part 11
compliance, validated database
Monitoring by exception via
automated alerts - OOT/OOS*
Maintains historical control limits
and process capability indices
Automated scheduled reports
available in a ready-to-use format
Bio4CTM ProcessPad
Solution
 Maintain process in a state of control
throughout the commercial lifecycle
 Know your process, understand the
causes of variation and proactively
reduce where necessary
 Regulatory expectations around CPV
 Regularly trend critical process and
quality parameters and take
corrective actions to address out-of-
trends/process inconsistency
 Develop detailed CPV plan with
regular documentation, reporting, and
reviews and supported by CPV-
informatics framework
Common
Challenges
Customer Needs
* SPC – statistical process control
OOT – Out of Trend
OOS – Out of Specification

24. Use Case:
CMO/Sponsor Data Sharing and Collaboration
 CMOs* need a platform to aggregate all
manufacturing data and share specific
product data with Sponsors
 Sponsors need to collect manufacturing
data for their products
 Scalable platform to expand the data access
by CMOs to their Sponsors and vice versa
 Multi-party collaboration
(CRO*/CMO/contract labs/Sponsors)
 Easily configurable platform so CMOs can
add new products/Sponsors
 Flexibility on number of users for wider
access without increasing cost
 Platform architecture allows easy access to
external parties
Product Specific
Access
Scalability &
Usability
Product/Process
Configuration
Licensing Model
Sharing Specific
Records
Enables product specific access by CMOs
to Sponsors and vice versa
End-users can easily configure a new
product in a short time frame
Easy deployment & use enables rapid
adoption across the network
Unlimited user/products means wider
data access & collaboration
Browser platform facilitates data sharing
to external parties, zero client footprint
Share specific analysis, dashboards and
routine process execution reports
Bio4CTM ProcessPad
Solution
Common Challenges
Customer Needs
Architecture that
Facilitates Sharing
*CMO – Contract Manufacturing Org
CRO – Contract Research Org

25. Sponsor 1
Organization
CMO hosts the
Bio4C™ ProcessPad
platform on cloud or
internal IT Network.
CMO provides specific
product data access to
respective sponsor
CMO
Bio4CTM
ProcessPad
Contract Test
Lab A
Sponsor login to
CMO’s Bio4C™
ProcessPad portal
to access or
monitor data
CMO IT Network or Cloud
Sponsor 2
Organization
Sponsor 3
Organization
CMO Hosted Platform with
Access to Multiple Sponsors and Contract Labs
Source: http://processpad.simplyfeye.com/blog21.html

26. Sponsor
Organization
CMO A
CMO B
Bio4CTM
ProcessPad
Contract Test
Lab A
Sponsor hosts
Bio4C™
ProcessPad
platform on
cloud or internal
IT Network.
Specific product
access and role
to respective
CMO partner
CMO C
CMO-C login to
Sponsor Bio4C™
ProcessPad portal to
upload data
Sponsor IT Network or Cloud
Sponsor Hosted Platform with
Access to Multiple CMOs and Contract Labs
Source: http://processpad.simplyfeye.com/blog21.html

27. Use Case: Acceleration of Investigations for
Discrepancies
 Process execution data spread across
information silos (ERP, LIMS, Paper
Records, LMS, QMS etc.) requiring huge
effort for data aggregation and analysis
 Ad hoc data assembly often results in poor
quality data with missing context
 Poor investigation outcomes and ineffective
CAPAs
 Delay in closures of investigations and
impact on quality metrics and supply chain
 Cumbersome data sharing methods and
limited cross-functional team collaboration
 Lack of uniformity in investigation
approaches and communications
 Reactive response to process/quality issues
Analysis Speed &
Available Tools
Reactive
Response
Disparate Data
Sources
Siloed Access to
Data & Tools
Impact on Quality
& Supply metrics
Rapid data visualization and analysis
(Timelines, Lot Genealogy, Profile Overlays,
Correlations, etc.)
Automated data assembly & integration in
a single browser window
Proactive response enabled with
automated trend alerts (OOT*)
Unlimited users enables wider platform
access for cross-functional collaboration
Rapid access to data drives effective and
prompt closure of investigations
Data-Driven
Culture
Enables rapid data-driven decision making
for process issues aided by uniformity
Bio4CTM ProcessPad
Solution
Common Challenges
Customer Needs
*OOT – Out of Trend

28. Use Case: Process Monitoring, Troubleshooting and
Optimization
 Live monitoring of machines only available
on plant floor; not easily accessible to
Process/MSAT Engineers; interfaces lack
analytics capability
 No easy-to-use statistical tools for routine
data analysis to increase process
understanding
 PD, scale-up and manufacturing data
remains scattered
 OOTs often go unnoticed and without
corrective action, it may lead to OOS
 Assembly of process execution data for real
time batch analytics is fragmented leading to
delays in event identification
 80% time spent in assembling data leaving
limited time for analysis for insights
 MSAT must plan experiments to gain
sufficient data for process optimization
Statistical
Tools
Process Lifecycle
Management
Disparate Data
Sources
Machine Data
& Analytics
Process
Understanding
Built-in statistical tools like Profile
Overlays, Correlations, Control charts,
Group Plots, ANOVA etc.
Automatic data assembly & integration
with timely single-window access
Captures all development and commercial
production data on single platform
Access to streaming machine data with
live batch monitoring and statistical
analysis
Time spent on quality analysis leads to
improved process knowledge, proactive
response to issues
Process
Optimization
Reduced MSAT burden for additional
experimentation for at scale/scale down
models
Bio4CTM ProcessPad
Solution
Common ChallengesCustomer Needs

29. Collaborative and intuitive
manufacturing intelligence
tool for process understanding
Out-of-the-box statistics and
data analysis tools means you
don’t have to be a data scientist to
get the information you need
Significantly increase employee
productivity with increased focus on
process insights and less time
hunting for data
Adaptable to any complexity
in batch manufacturing
process/products
(biologics, vaccines, small
molecules, gene therapies, etc.)
Minimal learning curve – easy to
use, intuitive browser-based
interface
Low maintenance, easy to
deploy, scalable browser-
based platform
Trusted single source of
truth for all process
execution data
Purpose built for the
biopharma industry
designed by bioprocess
engineers
Promote data-driven decision
making culture within
manufacturing and quality
organization
Tool to promote unified
process communication
language at all levels of
the organization
Key Product Highlights
Accessibility to all PD and MFG
data – on a single platform
Vendor agnostic with ability to
connect to multi brand process
equipment and electronic databases

30. The vibrant M, Millipore, MilliporeSigma, BioContinuum, 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.
© 2020 Merck KGaA, Darmstadt, Germany and/or its affiliates. All Rights Reserved.

31. Bio4CTM ProcessPad Software Resources
Questions