1. Gabriela Franco Salinas
BALANCE-project
Gabriela Franco Salinas
Rachel Pijls
May 31th, 2012

2. Introduction PharmaCell
Founded in January 2005
BioPartner Center in Maastricht
Pharmaceutical production for cell-based products
GMP license since 2006
WVKL (“Cell and Tissue”) license since 2007

3. Introduction PharmaCell
Focus on cell therapy and regenerative medicine
Development of specific technologies
Regenerative medicine (tissue regeneration)
Immunotherapy (cancer vaccines)
Cell culture technologies
Product development through partnerships
Financing through contract manufacturing, services and subsidies

4. Role of PharmaCell Aim: bring a cell-therapy product to the market
Perform development
Building a dossier to be ready for clinical trials
Start with Technology Transfer process
Phase I: Information Exchange phase
Technology Transfer list
GAP analysis and Risk analyses (e.g. QC tests)
Phase II: Implementation phase
Phase III: Validation phase

5. Content TT-list Content (not limited to): Detail Raw material
Doc transfer, CofAs, Excipient & (non) critical
Specifications
Doc transfer and agreement on in process, final, drug substance specifications
Process
Overview (flow chart), doc transfer, critical steps, robustness, focus for training
Validation status
Doc transfer, equipment, Production- & QC process
Documentation
Production, QC testing, labeling, training profile, TT protocol, validation protocol, validation master file
Logistics
Shipment starting material, shipment final product, customs EU
Final product container
Closure & Qualification
Stability Testing
Aseptic qualification

6. Goals TT Phase
Validation, robustness and critically status production, QC process & equipment
Implement in TT-list
Protocols and reports with related data
Development or robustness studies
Identification of critical process steps
Training profiles
Transfer QC testing
Required equipment and accompanied validation status

7. Persons involved Gabriela Franco Salinas Rachel Pijls
Master in Biomedical Sciences (2007, UvA)
PhD in Immunology (Nov 2012, UvA/AMC)
R&D Scientist at PharmaCell since 2011
Rachel Pijls
Master in Biomedical Engineering (2003, TUe)
PhD in Biomaterials and Drug Delivery (2007, UM/DSM)
Project manager/R&D Scientist at PharmaCell since 2009
To be determined…