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BioContinuum Platform for Next Generation Bioprocessing

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 %

pie1
73 10 7 10
pie1
60 40

Respondent Role %

pie1
57 43
pie1
40 33 27

Drivers & Hurdles

Market Trends, Business Drivers and Key Enabling Technologies*

BioPhorum Operations Group (BPOG) Technology Roadmap

Business Drivers

speed

Speed

0%

reduction in new facility build times

Compress production lead time by 80%

quality

Quality

0x

robustness

90% reduction in cost of poor quality

flexibility

Flexibility

0%

reduction in product change over time

cost

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
fact fact fact

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

cost-control
Control
Costs
augment
Augment Facility Flexibility
capacity
Enhance Capacity Utilization
Barrier

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

3 Barriers to Fully Continuous Processing

On-Line Analytics

Barrier

Batch Definition

Barrier

Company Culture

Barrier

Important Drivers for Adoption of Intensified Processing

  • I2

    93%

    Greater facility flexibility

  • I2

    90%

    Cost control (CapEx - OpEx - Labor - Other)

  • I2

    77%

    System complexity/ difficulty

  • I2

    74%

    Accommodate multiple molecules in the pipeline

  • I2

    67%

    Multi-use product facilities

  • I2

    60%

    Expertise with process development and tech transfer

  • I2

    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

pink

2018 - 2020+ | mAb Process Intensification

  • Perfusion
  • Intensified Capture
  • In-Line Viral Inactivation
  • Flow-Through Polishing
segreen

>2025 | Continuous Processing

green

Elements of Process Intensification Most Likely to be
Adopted in the Next 5-10 Years

2

Downstream Continuous Capture

1

Intensified Upstream Technologies

3

Buffer Management

usdUSP

dspDSP

60%

Intensified Fed-batch

60%

Continuous Capture
(Prot A / IEX)

53%

Cell-lineand Media Optimization

50%

New Approaches to Buffer Management

43%

New Capture Methodologies

40%

Perfusion

Context of Adoption

Process Intensification Efforts Already Adopted at Some Level in Most Respondents’ Organizations

Cell-line and Media Optimization bikker

27

Flow-through Chromatography bikker

27

Flow-through Polishing/Purification IEX bikker

22

New Approaches to Buffer Management bikker

16

Membrane Chromatography bikker

16

usdUSP

#respondents selecting each area; n=30 interviews

dspDSP

Main Reasons for Adopting Process Intensification Techniques So Far

Intensification is seen as a lever to:

  • Maximize capacity within existing facilities before investing in new facilities
  • Allow for new facilities to be built with smaller, more economically efficient processes
  • 0
  • Economics - Reduce COGS
  • 0
  • Capacity Utilization
  • 0
  • Size/Facility Footprint

In 10 Years...

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28%

of molecules in commercial manufacturing will utilize intensified USP

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35%

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

perpul-person perpul-person perpul-person perpul-person perpul-person perpul-person perpul-person perpul-person perpul-person

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New molecules in development

Second generation processes
for commercial molecules

Biosimilars

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Hybrid

Mostly single use

Mostly stainless steel

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New facilities

Both

Existing facilities

purpul-fact purpul-fact purpul-fact purpul-fact

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Who Adopts Process Intensification Where and Why?

Large and medium sized biotech/pharma

perpul-person perpul-person perpul-person perpul-person perpul-person perpul-person perpul-person perpul-person

Small biotech/pharma

yellow-person yellow-person yellow-person

CMOs

yellow-person yellow-person

Biosimilar manufacturers

yellow-person

New molecules in development

purpul-mol purpul-mol purpul-mol purpul-mol purpul-mol purpul-mol purpul-mol purpul-mol purpul-mol purpul-mol

Second generation processes
for commercial molecules

yellow-mol yellow-mol yellow-mol yellow-mol yellow-mol yellow-mol

Biosimilars

yellow-mol yellow-mol yellow-mol yellow-mol yellow-mol yellow-mol

Hybrid

purpul-hybrid purpul-hybrid purpul-hybrid purpul-hybrid purpul-hybrid purpul-hybrid purpul-hybrid purpul-hybrid purpul-hybrid purpul-hybrid

Mostly single use

yellow-hybrid yellow-hybrid yellow-hybrid yellow-hybrid

Mostly stainless steel

yellow-hybrid

New facilities

purpul-fact purpul-fact purpul-fact purpul-fact

Both

yellow-fact yellow-fact yellow-fact

Existing facilities

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