erik kakes, sales & marketing director applikon biotechnology · 2017-12-18 · about erik...
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Biosafety in upstream bioprocessingErik Kakes, Sales & Marketing director Applikon Biotechnology
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About Erik Kakes
• Studied Biochemistry
• Active in bioreactor design since 1988– Project manager
– Product development
– Marketing & Sales
• Co-owner of Applikon Biotechnology since 2008
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Applikon Biotechnology
• Largest privately owned bioreactor company in the world
• Started in 1974 by Jan van Burg
• Keywords: – Reliable
– New technologies
– Long term customer relation
– Micro scale to production scale systems
– Local experts for sales, service and support
– Bioreactor systems only
• Daughter companies in Netherlands, UK, USA, China
Jan van Burg
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About Applikon Biotechnology
Applikon Biotechnology
"providing reliable solutions for the bioprocess market that will enable an improved quality of life“
Erik Kakes, Arthur Oudshoorn, Jaap Oostra, directors Applikon Biotechnology
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Applikon Biotechnology
• Innovative Dutch Company (10% turnover goes to R&D)
• Fast growing (annual 25% in last 5 years)
• Enthusiastic team
• Long term vision
• Hightech & high-end products
• Part of Dutch knowledge economy
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Laboratory bioreactors
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Production systems
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•
•Applikon Inside! Single Use systems
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Applikon history in vaccine production
• 1970’s: Bilthoven units Dr. van Hemert & Ir. van Wezel
• 1989 Applikon and Contact Flow merger
• 1990’s: China Vaccine Project RIVM, DHV,
Applikon (supply 3 complete vaccine plants)
• Last 30 years Multiple large scale vaccine projects
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Phase 4
Pilot manufacturing, QC & QA
Clinical & Regulatory
Techtransfer
Pharmacovigilance
Lead Development
Preclinical Phase 1 Phase 2 Phase 3Product
Licensure
Process & Assay Development, Scale-up
Animal models
Discovery
QA / QP oversight including CMOs, CROs
CMC Project management
Facility development (See next detail slide)
Vaccine Development
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Commercial Manufacturing, QC & QA
Plant design & engineering
Procurement
Quality Systems development
Facility Construction
Equipment Delivery
Completion andcommissioning
Tech transfer andvalidation
Project management, Project QA and compliance management
Factory Licencing
Qualification
Recruitment & training
Techtransfer
Phase 4Phase 3 Product Licensure
Facility Development
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BioSafety & GMP
• Protect the operator
• Protect the consumer
• Reproducible results
• Controlled processes
• Documented processes
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Biosafety vs GMP
• Biosafety
– Protect the operator
• GMP
– Protect the consumer
Keep them in Keep them out
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GMP
• Enforced by law (CFR and Eudralex)
• Customer:– Provide safe products
– GMP and Eudralex
• Supplier:– Eudralex - Volume 4 for equipment
• Annex 2 and
• Annex11 (computer systems)
– 21CFR210 for equipment• Part11 electronic signatures
– ASME BPE design guidelines
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Biosafety
• Responsibility of supplier & customer
• Customer:– Provide safe environment for
personnel
– Inform supplier of potential risks
• Supplier:– Intrinsic safety as a design criterium
– Understand the process risks
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Recap: Bioreactor
Heating/cooling medium: TO JACKET
Heating/cooling medium: FROM JACKET
Gas Out
Sampling
Down Stream
=Risk Area
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Single-Use or Re-Usable
• Single-Use
– Short lead time
– Lower initial investment
– More flexibility
– Higher running costs
– More manual labor so more
procedures required
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Single-Use bioreactors
– Report April 2016, Dutch Commission for Genetic Modification
• Integrity test of bag not standardized
• Biggest risk is during installation wheremanual manipulation is the highest risk
• Continuous training programs are needed
• No reliable integrity test possible afterinstallation
• Increased risk for operator
• http://www.cogem.net/index.cfm/en/publications/publication/researchreport-updated-gmo-containment-risk-evaluation-of-single-use-bioreactors?
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Single-Use or Re-Usable
• Re-Usable
– Longer lead time
– Higher initial
investment
– Less flexibility
– Lower running costs
– Advanced automation
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Re-Usable bioreactors
• Benefits of process automation– Less manual manipulation
– Automated test procedures
• Integrity checks
• Sterilization checks
– Automated documentation
– Interlocks for increased safety
– Automated transfer between units
– Continuous feedback loops
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Recap: Bioreactor Biosafety
Heating/cooling medium: TO JACKET
Heating/cooling medium: FROM JACKET
Gas Out
Sampling
Down Stream
=Risk Area
No virus to exit
No virus to exit
No virus to exit
No virus to exit
No virus to exit
uncontrolled
No virus to exit
uncontrolled
No virus to exit
No virus to exit
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Recap: Bioreactor GMP
Heating/cooling medium: TO JACKET
Heating/cooling medium: FROM JACKET
Gas Out
Sampling
Down Stream
=Risk Area
No contaminant to enter
No contaminant to enter
Well defined materials
Homogeneous mixing
Defined gas supply
No contaminant to enter
No organisms to enter or
exit uncontrolled
No organisms to enter or
exit uncontrolled
Reproducible &
Controlled conditions
No organisms to enter or
exit uncontrolledNo contaminant to enter
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Equipment risk management
• Focus on the interfaces!!!– Different suppliers
• Building, upstream and downstream equipment
– Different equipment• Liquid flow path, connection types, temperatures, flows
– Different software solutions• Handshakes between devices, communication and
data integration, validation, unified operator interfaces
• Use as many standard building blocks as possible– Proven performance
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Gas Filters
Off-gas Incinerator
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Exhaust gas filter
• 0.2 micrometer pore size
• Membrane filter
• Integrity test points
• Test integrity before and
after process
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Exhaust gas filter
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Exhaust gas incinerator
• Temperature measurement & Control
• Time & heat kill, continuous monitoring
• 200 ˚C, Up to 200 l/min
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Agitator sealing
• Double mechanical seal
• Steam condensatelubrication
• Condensate pressure > reactor pressure
• Monitor pressure of condensate
• Preventive replacement of seal
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Agitator sealing
• Magnetic coupling: absolute sealing
• No direct contact between inside andoutside of reactor
• Minimal maintenance
• Up to 40 Nm torque
• Cell culture up to 3000 liter volume
• Microbial up to 500 liter volume
Tipspeed: π*N*Di Power:
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Liquid addition
Manual single shot addition Manual resterilizableaddition
Automated resterilizableaddition
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Vaccine productionscale systems
• Projects
– One time process
– Custom design
– Fixed time
– Fixed budget
• Communication is
key!!
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• Clear Project Execution Vision provides:
– Risk management during the project
– An integrated project approach
– A joint approach to achieve regulatory compliance
– Up front specification before implementation
– Continuous communication about the project status
– Effective project control measures
Project risk management:
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New vaccine production risk management
• Fast track vaccine manufacturing solutions
– Proven and documented processes
– Proven and documented procedures
– Proven and documented engineering solutions
– Proven and documented partnerships
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Case Sudy:
Manufacturing a cGMP production plant
by Applikon Biotechnology
• Fully integrated production upstream facility
• Full cGMP and Biosafety
• Scalable systems and transfer lines
• Integration of 3rd party systems
• Fully automated operation
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User Requirement Specifications
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The road from specifications to operational
product
• Create Process Flow Diagram (PFD) and detailed quotation
• Order received
• Create project management website
• Piping and Instrumentation Diagram (P&ID)
• Functional Design Specifications (FDS)
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PFD made according URS
Define the interfaces
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Schematic transfer lines
Define the interfaces
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Project management communication
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Project management communication
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Hazop study
• What is Hazop?
– Hazard and operability study
– a structured and systematic examination of a
complex planned or existing process or
operation in order to identify and evaluate
problems that may represent risks to
personnel or equipment
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Hazop study report
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Hazop rating
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Hazop actionlist
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Factory Acceptance Test
• Mutually agreed tests
• Test of performance &
safety (interlocks etc.)
• Supplier utilities
• Supplier location
• End of manufacturing
• Packing and shipping
(risk analysis)
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Transport
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Arrival and unpacking
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Installation
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Site Acceptance Test
• Mutually agreed tests
• Test performance & safety
• Customer utilities
• Customer location
• Next is PQ by customer
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Operation and performance testing
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Conclusions
• Biosafety is responsibility of supplier & customer• GMP and Biosafety should be combined in design• Automation can help reducing risks• Standard solutions reduce project and safety risks• Risks are in every step of the process and need to be
identified and minimized• Experienced partners reduce risks• Open communication during project is key to
success
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Thank you!