FROM BIO MANUFACTURING 4.0
TO A PATIENT CENTRIC APPROACH
Industry 4.0 is a revolution in Industry.
Most ideas are applicable in Pharma or Biotechs.
Sapristic-BiiON and 7 partners develop new tools inspired by Industry
4.0.
It’s a project from BioWin called BioCloud 4.0.
Jean Martin
Founder and Chairman of SAPRISTIC-BiiON
President AGORIA Wallonie
President Digital Wallonia Hub
BiiON :
Technologies
for Health
Visionaries
BIO MANUFACTURING 4.0
Why Industry 4.0 ? Current model is obsolete in some sectors
Issues
- The world became VUCA : Volatility Uncertainty – Complexity – Ambiguity.
- Some investment cycles are longer than
economic cycles
- People want customized products
Some industries are nearly in burn out .
Industry needs a disruptive model
BIO MANUFACTURING 4.0
Industry 4.0 : technological building blocks are available
Decision-making computing
•
•
•
•
•
machine learning
algorithms
big & smart data
Cloud
Simulators
Connected Things
•
•
•
•
Physical and digital objects
IoT
Reliable wireless
Data acquisition
Advanced robotics
•
•
•
•
•
Cyber Physical Systems
Cobots
Intelligent machines
Autonomous vehicles
Additive Technologies
Technology is no more the limiting factor
BIO MANUFACTURING 4.0
Industry 4.0 : paradigms
1.
•
•
2.
Transfer of the cost of diversity to digital.
Unit cost price no more related to volumes.
Location near to the market :
•
•
3.
6.
Learning teams
•
7.
Better turnover of assets
Management by mentoring
A clean, attractive and rewarding industry
Network of small highly automated factories
24/7
Labor cost becomes minor
Industrial revolution 4
Digital
Cyber-Physical Systems
Dynamic supply chain :
•
•
4.
Industrial revolution 3
Less stock & dynamic pricing
Additive technologies
Automation
Electronization
Digital continuity during all life cycle
•
•
•
5.
•
Mass customization :
Industrial revolution 2
Electricity
Petrol
Production line
Product is source of data and knowledge
Services throughout the entire value chain
Personalized interaction
Reduced consumption of assets
Industrial revolution 1
Steam
Mechanization
End 18th century
Begin 20th century
1970
Network of
smart
factories
Dynamic
Ecosystem
s around
digital
platform
Nowadays
BIO MANUFACTURING 4.0
Industry 4.0 : (Bio)pharmaceutical industry drivers
1.
Individualization :
•
Customized medicine
5.
Cost pressure :
•
2.
•
Direct link to patient :
•
3.
Complex logistics :
•
•
4.
•
Track compliance of patients with treatments
Customized medicine
Temperature requirement
6.
Health system
Ageing population
Therapies get more expensive
Small batches
•
Manufacturing flexibility
Track & Trace :
•
Increasing legal requirements (serial number,
…)
Ensure safe products (quality & safety)
Compliance with regulatory requirements
Produce with high efficiency
BIO MANUFACTURING 4.0
Industry 4.0 : Autologous therapies industry (patient-centric)
Biopharma 4.0 drivers “amplified”
Industry 4.0 is the solution to
produce quality treatment at an
affordable price
BIO MANUFACTURING 4.0
Biocloud 4.0 vision : a complete and open platform
4
Encompass the expanded value chain
Digital continuity
ERP – logistics – connected customers and products
3
Hyper automatization
Smart control – digital transverse integration
Accurate components
2
Manage smart data
Acquisition – local storage and in cloud
Open architecture for any suppliers
1
Interconnectivity in clean rooms
Wired and Wireless in Faraday cage
Open architecture for any suppliers
BIO MANUFACTURING 4.0
Connecting clean rooms
1.
Clean rooms offer a challenging
environment for sensors and networks
•
•
•
•
Faraday cage
Sterile / no particles
Flush and cleanable
Small autonomous sensors
• Wireless sensors
• Radiating cable
Today
2.
More and more connected objects inside
the clean room
•
•
Two-way communication
Growing bandwidth requirements
• Geolocation
• Energy harvesting
• Wireless
100%
qualified for
pharma
• Refined
pressure
sensors
2017
2020
BIO MANUFACTURING 4.0
Universal communication platform
Equipment
Building
Sensors
Smart Data
Smart Alarms
SOP for action
Products
Operators
&
Engineerin
g
System Health
People
Other providers
15/12/2016
Confidential
9
BIO MANUFACTURING 4.0
Hyper automatization applied to pharma
1.
Example : Executable SOPs
•
•
2.
Digital era
Applicable to any GMP related activities (e.g.:
batch production, line clearance, material
maintenance, uBio…)
Design
Execute
Prove
Executable SOP
Product/Process design
•
3.
Digital design of procedures
Controlling/Command
•
•
•
•
4.
Automated creation of batch record
Automated verification of equipment
availability, raw mat, staff…
Automated data capture and calculation
Release by exception
Workstation
•
•
Enhanced operator / Contextual guidance
Easy access to instructions
T
Transform
f
regulatory
l t
constraints
t i t into
i t operational
ti
l
efficiency
Ensure data integrity (single source of truth)
Compliance ensured by design
BIO MANUFACTURING 4.0
Encompass the expanded value chain
ERP/SCM
Supplier Mgt
CRM
Track & Trace
EMR
Connected
patient
Community doctors/pharmacists
Just in time production
T k bilit Traceability
Trackability,
T
bilit & G
Genealogy
l
off th
the ffullll value
l
chain
The right treatment to the
right patient at the right time
BIO MANUFACTURING 4.0
Conclusion
Biopharma & Biotechs
companies face new
challenges
Industry 4.0 offers tools &
principle to cope with this
complexity
(cost pressure, small batches,
increased regulation…)
(IoT, smart sensors, smart
factory…)
Biion, boosted by its deep
knowledge of the Pharma,
offers with its BioCloud4.0
partners a disruptive
platform to address those
challenges
Encompass the expanded value
chain
Hyper automatization
Manage smart data
Interconnectivity in clean rooms
BiiON is the Industry 4.0 enabler you need
!
Jean Martin, Chairman
BIION
Rue du Bosquet 2A
B – 1348 Louvain‐la‐Neuve
(+32) 10 77 23 00
[email protected]