Resources
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Advancing Manufacturing for Advanced Therapies
Speaker Presentation Marks Peter FDA 2018
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mRNA as a Platform Technology Ideally Suited for Individualized Therapeutics
Speaker Presentation Kuhn Andreas RNA Pharmaceuticals 2018
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FDA Perspective on Aseptic Process Simulation for Cell Therapy Product Manufacturing
Speaker Presentation Koo Lily FDA 2018
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From Academia to Industry: Lessons Learned in the Development of CAR-T Therapies
Speaker Presentation Kassim Sadik Mustang Bio 2018
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Regulatory Perspective on Potency Assays for Cell-Based Products
Speaker Presentation Hoefnagel Marcel Medicines Evaluation Board 2018
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Early Stage Manufacturing
Considerations for Cell Therapy
Products
Speaker Presentation Finn Thomas CBER FDA 2018
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Comparability Considerations in the Development of Gene Therapy Products
Speaker Presentation Baffi Robert BioMarin Pharmaceutical 2018
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Advanced Therapy Medicinal Products in Israel: Evolving Regulation
Speaker Presentation Axelrod Ofra Ministry of Health 2018
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Quality of Raw Materials and Manufacturing of Advanced Therapies
Speaker Presentation Atouf Fouad USP 2018
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Control Strategy for Extractables and Leachables
Roundtable 10 Notes: AT Europe 2018
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Software Considerations for Method Development and Data Evaluation
Roundtable 9 Notes: AT Europe 2018
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Automation
Roundtable 8 Notes: AT Europe 2018
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Implementation of USP<129>
Roundtable 7 Notes: AT Europe 2018
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Phase Dependent Requirements for Method Validation Across the Globe
Roundtable 6 Notes: AT Europe 2018
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Analysis of Polysorbate and Its Degradation Products
Roundtable 5 Notes: AT Europe 2018
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How to Translate Physicochemical Properties into Claims of Safety and Efficacy
Roundtable 4 Notes: AT Europe 2018
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Setting Specifications with Limited Batches and Analytics to Understand Process and Assay Variability
Roundtable 3 Notes: AT Europe 2018
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Charge Variants Analysis (cIEF/icIEF, IEC, CZE)
Roundtable 2 Notes: AT Europe 2018
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Mass Spec in QC
Roundtable 1 Notes: AT Europe 2018
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What is the State of the Art Regarding Methods for Analysis of Glycans and Glycoproteins?
Roundtable 9 Notes: AT Europe 2019