Gabriela Franco SalinasRachel Pijls

May 31th, 2012

BALANCE-project

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

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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

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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

o Technology Transfer list

o GAP analysis and Risk analyses (e.g. QC tests)

Phase II: Implementation phase Phase III: Validation phase

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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

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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

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Persons involved

• Gabriela Franco Salinas 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…

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