Learn more on the opportunities and hurdles of intensified, connected or continuous processing. 30 US and European biomanufacturers were interviewed to understand the likely future adoption of ‘Next Generation Bioprocessing’. Discover the animated version! http://www.merckmillipore.com/INTL/en/20180329_155610?bd=1&tab=2 Visit the BioContinuum™ Platform webpage now! http://www.merckmillipore.com/biocontinuum

1. Intensify and Evolve. Together.
BioContinuum™
Platform
Adoption of
Next Generation
Bioprocessing for mAbs
Current & Future Adoption Context of AdoptionDrivers & Hurdles
Next Generation Processing:
Evolutionary Journey Across Many Disciplines
Facility Goals
90%
90%
70%
90%
less
footprint
less
capital
reduction in
construction time
reduction
in OPEX
Barriers
• System complexity
• Expertise
• Availability of alternate suppliers
• Regulatory guidance
• Scale-up risk
• Tech-transfer risk
• Future difficulty finding CMO in
order to expand process
Customer Needs
Control
Costs
Augment Facility
Flexibility
Enhance Capacity
Utilization
3 Barriers to Fully Continuous Processing
1
On-Line Analytics
2
Batch Definition
3
Company Culture
Important Drivers for Adoption of Intensified Processing
Current & Future Adoption
Evolution to Intensified mAb Processing
is Already Happening Today
2018 | Standard mAb Process Template
2018 - 2020+ | mAb Process Intensification
>2025 | Continuous Processing
????????
Intensified Capture Flow-Through Polishing
In-Line
Viral Inactivation
ACID BASE ACID BASE
Perfusion
Elements of Process Intensification Most Likely to be
Adopted in the Next 5-10 Years
Intensified
Upstream
Technologies
12 3Downstream
Continuous
Capture
Buffer
Management
Intensified
Fed-batch
USP DSP
USP DSP
60%
Cell-line
and Media
Optimization
53%
Perfusion
40%
New Capture
Methodologies
43%
New Approaches
to Buffer
Management
50%
60%
Continuous
Capture
(Prot A / IEX)
#respondents selecting each area; n=30 interviews
Context of Adoption
Process Intensification Efforts Already Adopted at Some Level
in Most Respondents’ Organizations
Flow-through
Chromatography
27
Cell-line and
Media Optimization
27
Flow-through
Polishing/Purification IEX
22
New Approaches to
Buffer Management
16
Membrane
Chromatography
16
Main Reasons for Adopting Process Intensification
Techniques So Far
Who Adopts Process Intensification Where and Why?
• Maximize capacity within existing facilities before
investing in new facilities
• Allow for new facilities to be built with smaller,
more economically efficient processes
Economics - Reduce COGS
Capacity Utilization
Size/Facility Footprint
Intensification is
seen as a lever to:
17
12
4
In 10 Years...
28% of commercial molecules
will utilize intensified DSP
of molecules in commercial
manufacturing will utilize
intensified USP 35%
Large and medium sized
biotech/pharma
Small biotech/pharma
CMOs
Biosimilar manufacturers
Lifecycle products may also adopt
elements of intensification to optimize
current processes
They have the money to invest and
process expertise required, particularly
those with capacity constraints
Hybrid
Mostly single use
Mostly stainless steel
Intensified technologies mostly single use
at the clinical-scale and mostly hybrid at
the commercial scale
New facilities
Both
Existing facilities
Intensified processes incorporated in new
facility design
Existing facilities to implement single-use
intensification for process optimization to
overcome capacity constraints
New molecules in development
Second generation processes
for commercial molecules
Biosimilars
* Source: BioPhorum (BPOG)
https://www.biophorum.com/category/resources/technology-roadmapping-resources/introduction/ The BioContinuum™ Platform represents our belief in and commitment to the evolution
of bioprocessing. Together with our customers and regulators, we strive to accelerate
access to biopharmaceuticals for patients worldwide.
Whether developing an intensified, connected or continuous bioprocess, the
BioContinuum™ Platform provides the building blocks to help you achieve your
bioprocessing goals. This holistic and forward-looking view of biomanufacturing actively
incorporates connected software, controls and analytics across our portfolio of
technologies to make the factory of the future a reality.
The BioContinuum™ Platform is an expanding offering of proven and novel technologies,
applications and expertise enabling biotherapeutic manufacturers to confidently enter
the era of next generation processing by delivering increased speed, greater flexibility
and enhanced quality while reducing the costs and risks of navigating the evolving
biopharma landscape.
30 US and European biomanufacturers were interviewed
to understand the likely future adoption of ‘Next Generation
Bioprocessing’ for mAbs over the next 5-10 years
the survey focused on
primary research and qualitative results
CDMO
Mid-large Pharma / Biotech
Small Pharma / Biotech
Biosimilar Manufacturers
73 60
40
57
43
27
40
33
10
10
7
US
EU
VP / Head
(Sr.) Director
Technology / Innovation
Process Development
Manufacturing
Organization Type % Respondent Role %
Survey Respondent Demographics
Survey Scope
Drivers & Hurdles
Market Growth New Product
Classes
Cost PressureUncertainty
Speed Flexibility CostQuality
• High demand
• Number of drugs supplied
• Global reach
• Emerging markets
• Clinical efficacy
• Approvals: Complex
regulation
• Demand: Market share
• Regional requirements
• New modalities
• Personalized medicine
• Payer pressure on price
• Biosimilars and competition
• Cost of clinical failure
• Escalating development
costs
Market Trends, Business Drivers and Key Enabling Technologies*
Market Trends
Business Drivers
Key Enabling Technologies
70% 10x 90% 90%reduction in new facility
build times
robustness reduction in product
change over time
reduction in cost to
manufacture and
capital expenditure
Compress production
lead time by 80%
90% reduction in cost
of poor quality
Process
Intensification
Single Use
Process
Analytics
Software &
Automation
BioPhorum Operations Group (BPOG) Technology Roadmap
FACTORY
OF THE
FUTURE
Batch
Continuous
Process
Intensified
Connected
SU/Closed
Format
Stainless
Hybrid
Single Use
In-Line/
Real-Time
Sensing
Analytics
Standard
QC Methods
Rapid QC
Methods
At-line
Predictive
Process
Control
Controls
Stand-Alone
Control
Semi-Centralized
Control
Full Process
Control
Adaptive
Plant
Digital Plant
Pre-Digital
Plant
Digital Silos
Connected
Plant
Today
Near-term
Mid-term
End state
Intensify and Evolve. Together.
BioContinuum™
Platform
Cost control
(CapEx - OpEx
- Labor - Other)
90%
System
complexity/
difficulty
77%
Expertise
with process
development
and tech
transfer
60%
Reliable, robust
supply/availability
of alternate
suppliers
57%
Greater facility
flexibility
93%
Accommodate
multiple
molecules in
the pipeline
74%
Multi-use
product
facilities
67%
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