Explore
BioContinuum™ Platform
Continuous Processing:
Market Trends & Drivers
Advance & Digitize
Your Bioprocess
Survey Scope
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
Survey Respondent Demographics
Organization Type %
Respondent Role %
Drivers & Hurdles
Market Trends, Business Drivers and Key Enabling Technologies*
BioPhorum Operations Group (BPOG) Technology Roadmap
Market Trends
Market Growth
- High demand
- Number of drugs supplied
- Global reach
- Emerging markets
Uncertainty
- Clinical efficacy
- Approvals: Complex regulation
- Demand: Market share
- Regional requirements
New Product Classes
- New modalities
- Personalized medicine
Cost Pressure
- Payer pressure on price
- Biosimilars and competition
- Cost of clinical failure
- Escalating development costs
Business Drivers
Speed
0%reduction in new facility build times
Compress production lead time by 80%
Quality
0xrobustness
90% reduction in cost of poor quality
Flexibility
0%reduction in product change over time
Cost
0%reduction in cost to manufacture and capital expenditure
Key Enabling Technologies
Process Intensification
Single Use
Process Analytics
Software & Automation
Next Generation Processing:
Evolutionary Journey Across Many Disciplines
Facility Goals
- less footprint
- less capital
- reduction in construction time
- reduction in OPEX
FACTORY OF THE FUTURE
- Today
- Near-term
- Mid-term
- End-state
- Process
- Batch
- Intensified
- Connected
-
Continuous
- Format
- Stainless
- Hybrid
- Single Use
-
SU/Closed
- Analytics
- Standard QC Methods
- Rapid QC
Methods - At-line
-
In Line/ Real-Time Sensing
- Controls
- Stand-Alone Control
- Semi-Centralized Control
- Full Process
Control -
Predictive Process Control
- Digital Plant
- Pre-Digital
Plant - Digital Silos
- Connected Plant
-
Adaptive Plant
Customer Needs
Control
Costs
Augment Facility Flexibility
Enhance Capacity Utilization
3 Barriers to Fully Continuous Processing
On-Line Analytics
Batch Definition
Company Culture
Important Drivers for Adoption of Intensified Processing
-
93%
Greater facility flexibility
-
90%
Cost control (CapEx - OpEx - Labor - Other)
-
77%
System complexity/ difficulty
-
74%
Accommodate multiple molecules in the pipeline
-
67%
Multi-use product facilities
-
60%
Expertise with process development and tech transfer
-
57%
Reliable, robust supply/availability of alternate suppliers
Current & Future Adoption
Evolution to Intensified mAb Processing
is Already Happening Today
2018 | Standard mAb Process Template
2018 - 2020+ | mAb Process Intensification
- Perfusion
- Intensified Capture
- In-Line Viral Inactivation
- Flow-Through Polishing
>2025 | Continuous Processing
Elements of Process Intensification Most Likely to be
Adopted in the Next 5-10 Years
Downstream Continuous Capture
Intensified Upstream Technologies
Buffer Management
USP
DSP
Intensified Fed-batch
Continuous Capture
(Prot A / IEX)
Cell-lineand Media Optimization
New Approaches to Buffer Management
New Capture Methodologies
Perfusion
Context of Adoption
Process Intensification Efforts Already Adopted at Some Level in Most Respondents’ Organizations
27
27
22
16
16
USP
#respondents selecting each area; n=30 interviews
DSP
Main Reasons for Adopting Process Intensification Techniques So Far
In 10 Years...
of molecules in commercial manufacturing will utilize intensified USP
of commercial molecules will utilize intensified DSP
Who Adopts Process Intensification Where and Why?
Large and medium sized biotech/pharma
Small biotech/pharma
CMOs
Biosimilar manufacturers
New molecules in development
Second generation processes
for commercial molecules
Biosimilars
Hybrid
Mostly single use
Mostly stainless steel
New facilities
Both
Existing facilities
Who Adopts Process Intensification Where and Why?
Large and medium sized biotech/pharma
Small biotech/pharma
CMOs
Biosimilar manufacturers
New molecules in development
Second generation processes
for commercial molecules
Biosimilars
Hybrid
Mostly single use
Mostly stainless steel
New facilities
Both
Existing facilities
