technology transfer and working with a cdmo: challenges...
TRANSCRIPT
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Technology transfer and working with a CDMO: challenges and important aspects to consider for an efficient partnership
Prerequisites for a successful tech transfer, typical example of tech transfer – tips, common mistakes, lessons learned
PDA IsraelTechnology Transfer and Working with CMO/CDMOTel Aviv, 4th March 2019
Riccardo Bernasconi, PhDCARBOGEN AMCIS AG
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Brief introduction of Carbogen Amcis – setup and capabilities
Prerequisites for a successful tech transfer – common pitfalls
Example of a tech transfer recently performed at Carbogen Amcis
Lesson learned
Presentation Overview
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CARBOGEN AMCIS – Key Facts
• Over 30 years experience in process development and manufacturing – from early phase to commercial supply
• Global presence – 8 manufacturing sites
• 800 employees
• Swiss CDMO – part of the Dishman Carbogen Amcis Ltd.
• More than 150 complex projects per annum
• 75% of projects are return customers
• Commercial supply into major markets (US, EU, Japan, Australia, Brazil, India,…)
• Highly successful audit history
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Footprint of CARBOGEN AMCIS
• Process development• Full analytical support• Manufacture (from 6 L to 8’000 L)
• High potency• Preparative chromatography• Flow chemistry
• ADCs• Drug product (aseptic filling)
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General assumptions
Prerequisites for a successful tech transfer
• Who owns the IP?
• CDMO philosophy of project management
• Approach to process R&Do Regulatory requirements / regulatory history of the siteo Who has the knowledge
• Factors influencing cost, quality and speedo From RFP to POo It’s not just when the CMO can start, but when the legal paperwork can be signed
• Site visit & site audit
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• Project timelineo Set realistic timelines (both for you and the CDMO)o Ensure the project plan captures all deliverables
Prerequisites for a successful tech transfer
• Define the start date
• Technology transfero Face-to-faceo Technical-to-technicalo Transfer of knowledge (transfer of Scientist)
• Resources / equipment / processes in place to handle challenges
• Communication – when, where and how ofteno Routine project updateso When something goes wrong – define clear communication channels
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Prerequisites for a successful tech transfer
Research Preclinical Phase I Phase II Phase III Market
EARLY STAGEProcess Research and RapidSupply of APIs preparedaccording to non-GMP
LATE STAGEProcess Development
and cGMPManufacture
COMMERCIALProcess Optimisation
COGs OptimizationFDA audited
• Mindset / setup of the CDMO
• Maturity of the project
• Project complexity / challenges
• Short vs. long term expectations
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Prerequisites for a successful tech transfer
• Project management – responsibilities at the CDMO
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Prerequisites for a successful tech transfer
Generate Technology Transfer Plan
Initiate project and transfer information
Change Review
Lab Trialing
Perform Pre-formulation Review
Production and Analysis
Production and Quality Comparison
Technology Transfer Protocol
Technology Transfer in the SOP
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Target: Manufacture of an Antibody Drug Conjugate (ADC)
Starting point: Elementary lab procedure, rudimentary analytical methods
Timeline: 2 years – from process development to multi grams non-GMP batch
Deliverables: - Process development report- Full analytical report- Scale up report- non-GMP material- cGMP material
Successful tech transfer – case study
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Highly potent containment
Successful tech transfer – case study
3x Building block synthesis
Solid phase transformation
Chromatographic separation
Conversion to Payload
Antibody conjugation
Fill and finished formulation
Manchester site
2 steps11 steps6 steps
Neuland site
15 steps
Aarau site Bubendorf site
4 steps
Bubendorf site
1 step
Riom site
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• 39 chemical steps• 5 manufacturing sites involved• 5 developmental teams involved in process implementation, development and
scale-up activities• 24 months from tech transfer to first non-GMP delivery• 12 months scale up and first cGMP campaign• 1 project management
Successful tech transfer – case study
Client
PM
Site 1 Site 2 Site 3 Site 4 Site 5
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Support from the client:
• During tech transfer and process optimizationo Full technical supporto Few experiments performed by the client
• During production and scale-upo Technical and paper support
Successful tech transfer – case study
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Lesson learned
• Project management
• Technical team
• Response rate and responsiveness
• Expectations vs. reality
• Partner vs. supplier
• Saving vs. investment in process development
• Communication, communication and…..communication!