Learn how Bigfinite helps improve pharmaceutical manufacturing operations with the use of artificial intelligence and IoT technologies.

1. “This ISPE Discovery Stage demonstration is a promotional activity and not approved for continuing education credit.
The content of this demonstration and opinions expressed by presenters are those of the presenter and are not of ISPE.”
Turn Your Operations Into Your
Competitive Edge!

2. Need for manufacturing capacity
is rapidly changing
The Pressure to Perform - External Catalysts for Change in Pharma Industry
42%
Of all new drug approvals by
FDA in 2018 were
personalized medicines
51%
Reflection in average tenure
of leading product per
therapeutic area (2001-2008)
Personalized
Medicine
Genetics &
Biosimilars
10x
Bio-process unit output increase in
continuous processes, higher tiers
per Biogen presentation PDA AM
(2018)
Process
Intensification

3. Current State of the Industry
$50B
wasted by US Pharma
manufacturers alone,
each year
>70%
of manufacturing data is
not being used
Complex (and Largely Analog) Industry!

4. Fulfilling Requirements at the Expense of
Efficiency
Need For Agility in Stark Contrast with Current State - Stuck with Rigid Supply Chains
Meet production
goals
Balance
trade-offs
Ensure quality
& compliance
Legacy
Greatly
inefficient

5. Digital Transformation is Necessary
No industry is immune to technology and change!
Pharma 4.0

6. “Manufacturing processes can not be
improved due to incomplete understanding
of operational realities...”
Core Challenge at the Root of Wasteful Manufacturing Processes

7. “Advanced Analytics could improve EBITDA
for pharmaceutical companies by 45%-
75%”
Digital Champions Win by Maximizing Understanding of Product, Materials and Processes
Increase yield
Reduce operating
costs
Faster lot release
& time-to-market Enhance GxP compliance, data
integrity, and inspection readiness

8. “If you had all possible information at your
fingertips, what problems would you be
solving?”
What if? - Pharma Manufacturing Issues
Predict CQA’s?
Prevent VOC
emission
excursions?
Which CPP’s
causes most
variation?
Visual inspection
using image
recognition?
Breakdown data silos
with integrated
dashboard?
From
research
To
patient

9. Example #1: Novo Nordisk - Predictive OEE (Real-time Failure Diagnostics)
Real-Time Failure
Diagnostics

10. Example #2: Takeda - Optimizing UPB Pooling
Predicting
Downstream Yield

11. Siloed Data
70% unused
IoT
CLIMA SAP
ERP
MES
Legacy IoT
ERP
MES
IoT
ERP
LIMS
CLIMA Users
Tailored
Solutions
SaaS Platform
Regulated
Data Lake
Predictive
Insights

12. Real-time Data Ingestion using IIOT

13. Real-time Data Ingestion using IIOT

14. Root Cause of Your Manufacturing Inefficiencies

15. Real-time Process Feedback Against Optimal Target Models and Avoid Future Problems

16. Real-time Process Feedback Against Optimal Target Models and Avoid Future Problems

17. Accepted into FDA’s
Emerging Technology Team
Bigfinite is 2018
Cool Vendor in Life Sciences
Industry Validation
“Bigfinite: The first company to provide a
purpose-built, qualified and validatable for
good x practice (GxP) environments,
software as a service (SaaS)-based
advanced analytics package that uses AI,
machine learning (ML) and deep learning in
a pharma manufacturing environment.
”
Bigfinite's ... technology and approach
proposed by your firm is novel and will have a
significant impact on product quality.
... your technology is likely to influence how
quality systems will be assessed by the FDA.
“
”

18. Come visit us at
booth #241!