The document discusses the benefits of single-use technologies (SUT) in the pharmaceutical manufacturing sector, emphasizing advantages such as flexibility, efficiency, cost reduction, and lower contamination risk. It highlights how SUT can accelerate tech transfer and improve overall plant efficiency by minimizing non-value-added steps and optimizing resources. The trends and case studies presented demonstrate the increasing adoption of single-use and flexible factory concepts in life sciences manufacturing.

1. The life science business of Merck KGaA, Darmstadt, Germany
operates as MilliporeSigma in the U.S. and Canada.
L. Botrel & J. Pionchon
October 28, 2021
Advantages of
Developing Processes
and Manufacturing API
with Single-Use
Technologies

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

3. Agenda
Benefits of Single-Use Manufacturing at
Commercial scale – L. Botrel
Commercial Manufacturing
Building with SUT – Case study
J. Pionchon
1
2

4. Benefits of Single-
Use Manufacturing at
Commercial scale
1

5. Advantages of Developing Processes and Manufacturing API with SUT
5
Single-use Technologies enable Flexible Factories
Single-Use
Single-Use technologies advantages
Speed to market
Limit contamination risk
Rapid suite configuration
Simplified process validation and TT activities
Reduce capital expenditures
Flexibility Efficiency Cost

6. Advantages of Developing Processes and Manufacturing API with SUT
6
The trend of Single-Use & Flexible factories is increasing
Single-Use
Flexible factory
concept
SU advantages
Flexibility Efficiency Cost
Modularity &
adaptability
Easy & fast
modification
• Single-Use facility
designed for ease of
use
• Rapid & Flexible
installation
• Reduced utility
requirements
• Minimized need for
WFI & CIP solutions
• Rapid suit
configuration for
different processes
• Rapid change over
between batches
• Reduced risk of
contamination
• Smart implementation
of Single-Use
technologies
• Lower cleanroom
classification

7. Single-Use
Single-Use equipment implementation improve plant efficiency
Advantages of Developing Processes and Manufacturing API with SUT
7
Equipment can be moved from one suit to another
No need for hard piping
Modular equipment
Fewer SIP/CIP steps
Down-Time Reduced
SU advantages
Flexibility Efficiency Cost

8. Advantages of Developing Processes and Manufacturing API with SUT
8
Non-added value steps are reduced with Single-Use technologies
Single-Use
SU advantages
Flexibility Efficiency Cost
CAPEX
OPEX
Savings on Electricity
& Water consumption
per run
Fewer technicians
are needed to
operate a disposable
process
No hard piping
installation/qualificati
on maintenance
Footprint
optimization
Time
Technicians training
& on-boarding
Equipment
polyvalence
15% time
saving for
mAb projects
≈40 to 50%
plant capacity
increase

9. Successful Tech Transfer
Leveraging Single-Use systems
“The goal of technology transfer activities is to transfer
product and process knowledge between development
and manufacturing, and within or between
manufacturing sites to achieve product realization. This
knowledge forms the basis for the manufacturing
process, control strategy, process validation approach,
and ongoing continual improvement.”
How Single-Use
implementation is
impacting
Tech transfer ?
ICH Q10
Transfers have to be performed in an organized, methodical
manner, with appropriate documentation.
Tech transfer Good practices
Advantages of Developing Processes and Manufacturing API with SUT
9

10. Advantages of Developing Processes and Manufacturing API with SUT
10
Single-Use Technology accelerate & de-risk scale-up & tech transfer
Leveraging Single-Use systems
We accelerate & de-risk tech transfer with pre-defined Upstream/Downstream
protocols and models using single-use equipment technologies from bench to
GMP production operations
✓ Process Gap analysis
✓ Process Optimization
✓ Process Scalling
✓ Process fitting to commercial facility

11. Commercial
manufacturing facility
using SUT
Case Study
2

12. To see the rest of the
presentation and get more
information about our
case study, participate in
the full, interactive on-
demand webinar.
Watch now

13. The vibrant M and BioReliance 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.