new production methods and convertible systems to increase ... stainless steel *estimated benefits...
TRANSCRIPT
GE - GAP meeting WHO July 13th 2011
New production methods and convertible systems to increase epidemic or pandemic
surge capacity
GE - GAP meeting WHO July 13th 2011
Agenda
• GE Enterprise Solutions • Plant in box – Illusion or reality ? • Disposable technology and construction modules • Case study – Manufacturing of Flu vaccine in a Box • Conclusion
GE - GAP meeting WHO July 13th 2011
Our Enterprise Solutions Vision
Leverage GE’s expertise to deliver
customized cost-effective solutions to enable our customers own capability in bio manufacturing.
GE - GAP meeting WHO July 13th 2011
Vaccines Plasma Biosimilars Insulin
• Self-sufficiency
• Speed to
Manufacturing
• Key Vaccines:
• Pandemics
• Seasonal
• Competitive
advantages
• Self-sufficiency
• Local, optimal
products
• Rapid return on
investment
• Self-sufficiency
• In-country
manufacturing
capability
• Lower overall
procurement costs
• Increasing patent
expirations
• Self-sufficiency
• In-country
manufacturing
capability
• Lower overall
procurement costs
Enterprise Solutions Focus Areas
GE - GAP meeting WHO July 13th 2011
IP Process
Development Engineering Hardware Construction
Plant Operation
A dedicated technical team for a turnkey vaccine plant
Confidential & Proprietary
+
Project Management, Regulatory support
Tech transfer, Training of people, Validation
GE - GAP meeting WHO July 13th 2011
Plant in a Box – Can the dream come true ? You see things; and you say, "Why?" But I dream things that never were; and I say, "Why not?"
- George Bernard Shaw
GE - GAP meeting WHO July 13th 2011
Plant in Box <=> Need the right combination of disposable technology and modular construction
• Possibility to produce more thanks to
shorter changeovers
• Possibility to switch from one vaccine to
another one very fast
• No cross contamination • Lower investment
• Environmentally friendly
• Much faster
• Design and construction on same site
• More time to select site and prepare
infrastructure
• Possibility to move entire construction to another site
Disposable technology = ReadyToProcessTM
GE - GAP meeting WHO July 13th 2011
GE’s ReadyToProcess™ (single use) platform – Upstream & Downstream, Plug & Play Processing
ReadyToProcess is more than ‘disposables’ It is an integrated platform of ready-to-use solutions for flexible
biomanufacturing strategies and upstream & downstream applications
GE - GAP meeting WHO July 13th 2011
Disposable Mixers
Normal Flow Pre-sterile
Filtration ULTA™
Capsule
Flow Path Welding Solutions
Ready to Use Chromatography
solutions
Genderless
Disposable Aseptic
Connectors
Custom Bags &
Integrated Assemblies
ReadyToProcess™ Products & Tools by GE
AKTA ™ ready
System
Sterile Cell
Harvest Kit 2011
Standard Bags &
Kit Assemblies
Circuit Hardware
Disposable WAVE
Bioreactor ™
ReadyCircuit On Line
Designer
Single Use Crossflow
TFF
GE - GAP meeting WHO July 13th 2011
Environmental Impact Soft
Reducing energy
consumption by 43% per year
Saving over 66,000 liters of water per year
equal to about 3 tanker trucks
Reducing turn-around time by 1,300 hours or 92% compared
to stainless steel
*Estimated benefits for replacing a 500 liter stainless steel bioreactor
with a WAVE 500 bioreactor system and 40 batches on an annual basis.
Example WAVE 500L Bioreactor
GE - GAP meeting WHO July 13th 2011
Building Execution Approaches
Traditional Execution
• Requires qualified contractors & infrastructure
• Execution in brick / steel / concrete
Modular Execution
• Prefabricated / preassembled / partially tested
• Advantages:
– in countries with limited skilled contractors
– at sites with severe space restrictions
GE - GAP meeting WHO July 13th 2011
Building Modules • The module (“cell”) includes all
structural elements and service installations (utilities, HVAC, electrical systems)
• Module contains also all process installation
• It is fabricated and tested at manufacturing site (pressure/integrity and cleaning/passivation)
• It is then shipped and connected at customer site
GE - GAP meeting WHO July 13th 2011
Installation of HVAC
GE - GAP meeting WHO July 13th 2011
Interiors of Modules
GE - GAP meeting WHO July 13th 2011
Delivery and construction on site
GE - GAP meeting WHO July 13th 2011
Case study Plant in Box for influenza vaccine manufacturing
GE - GAP meeting WHO July 13th 2011
Disclaimer
• Flu process that was used for the simulation is based upon a non commercial process
• All Capex, Opex and Costs per dose mentioned are projections based upon educated basis and indicative
GE - GAP meeting WHO July 13th 2011
Influenza vaccines
GE used an MDCK Whole Virus Inactivated process that was developed in house but not marketed
Economics presented later would look even better with …
A Live attenuated vaccine technology
• Low scale needed: 0.4-2 million doses / 100 L harvest if 20% yield
Whole virus
Inactivated Split virus Live attenuated Subunit
GE - GAP meeting WHO July 13th 2011
Influenza vaccine process
MDCK Cell Culture Seed Train
NFF Harvest Filters
Concentration &
diafiltration Concentration &
diafiltration
Chromatography
Sterile filtration
Virus Seed Train
Inactivation
20 L Wave 150 L Wave
2 x 20 L Wave
2 x 1000 L SUB
GE - GAP meeting WHO July 13th 2011
Example of Modular Vaccine Facility
• 1000m2 footprint
• Each module 4.5m * 10m
• BSL2
• 2 floors
• All utilities included as well as HVAC
N.B: BSL3 and Ex-proof is possible as well as Fill & Finish expansion
GE - GAP meeting WHO July 13th 2011
Production cost idea per dose
Inactivated Influenza Live Attenuated Influenza
Capex (MUSD) 19 19
Opex per year (MUSD) 7.6 6.1
Doses per year 14 mio 77 mio
Cost per dose (USD)* ~0.55 ~0.08
*Excluding fill and finnish
GE - GAP meeting WHO July 13th 2011
A plant up and running very fast 12-18 months
Activity Month
1 2 3 4 5 6 7 8 9 10 11 12
Planning
Execution, installation (HVAC, Utilities)
Transportation
Assembly, start-up, commissioning
GE - GAP meeting WHO July 13th 2011
Conclusions
GE - GAP meeting WHO July 13th 2011
Plant in Box = a fast and cost effective solution
• Offers a manufacturing solution within a typical 12-18 months timeframe
• Disposable technology reduces Capex significantly and enable maximum flexibility in case of pandemia
• Tech transfer and training of people is easier and risk of cross contamination almost disappearing
• Plant in Box can be a very generic concept to be copy paste in several countries
GE - GAP meeting WHO July 13th 2011
Thank you
GE Healthcare Bio-Sciences AB
Björkgatan 30 751 84 Uppsala
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