Day 1 – Thu, February 23rd
Annex 1 – GMP Compliance when working with Robotics in Aseptic Processing
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Richard Denk, Senior Consultant Aseptic Processing & Containment at SKAN AG
Aseptic processing applied in Gene & Cell therapy following QRM principles
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James Drinkwater, Head of GMP Compliance at Franz Ziel
Morning Coffee Break
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Modular and Flexible Robotics Systems for CGT
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Fabian Stutz, CEO at Pharmabotix AG
FDA’s Regulatory Review and Inspection of Biological Products Manufactured Using Aseptic Processing
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Zhihao Peter Qiu, External Advocacy Lead China at Roche Genentech
Meeting the challenges of Annex 1 with innovation in rapid H2O2 validation.
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Kate Marshall, Technical Director at Protak Scientific
Overcome development and manufacturing challenges for viral vector sterilizing filtration
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Chiara Pacini, Bioprocess Specialist at Pall Corporation
Developing stem cell-based gene therapy for RAG1 and RAG2 deficient SCID
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Frank J.T. Staal, Professor at Leiden University Medical School
Sleeping Beauty Transposon Vectors for Therapeutic Applications
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Zsuzsanna Izsvák, Group leader at Max Delbrück Center of Molecular Medicine, Berlin
CMC considerations for Cell and Gene therapy products
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Alison Armstrong, Senior Director, Global Head Technical and Scientific Solutions at Merck KGaA
DGE-AUC: Adapting the Power of Density Gradient Separations for Gene Therapy Analytics
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Lutz Ehrhardt, Senior Marketing Manager Centrifugation at Beckman Coulter Life Sciences
DGE-AUC: Adapting the Power of Density Gradient Separations for Gene Therapy Analytics
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Lutz Ehrhardt, Senior Marketing Manager Centrifugation at Beckman Coulter Life Sciences
Panel Discussion
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Ensuring clinical success: Clinical data generation
The future and commercial sustainability of ATMPs
ATMP – Regulatory, process and supply chain: Challenges & opportunities
CGT Bioprocessing and digitalization
Viral-Vector Therapies at scale: today’s Challenges and future opportunities
Chairperson Closing Remarks and end of the 1st day sessions
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Gala Dinner at Mélia Milano Hotel
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With Live Portuguese FADO Music