Papers and Presentations
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Global Regulatory Strategy for Cell Therapy Development and Manufacturing
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Speaker Presentation: Consultants' Network 2026 Xu Jingying, Kite Pharma, Inc., 2026 -
From Clinical Promise to Scalable Reality: How CMC Challenges Are Shaping the Future of Autologous Cell Therapies
Speaker Presentation: Consultants' Network 2026 Sabatino Marianna, AstraZeneca, 2026
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How Challenges Are Shaping ALLOGENEIC Cell Therapy Drug Product Manufacturing and CMC Strategies
Speaker Presentation: Consultants' Network 2026 Heidaran Mo, Cellx, Inc., 2026
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Development of New Reference Material for Biopharmaceutical Advancement
Speaker Presentation: Consultants' Network March 2026Telikepalli Srivalli, National Institute of Standards …
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Visible Particle Control in Biologics and ATMPs: Bridging Regulatory Requirements with Practical Qualification Standards
Speaker Presentation: Consultants' Network March 2026Koulov Atanas, Clear Solutions Laboratories, …
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Advancing Targeted LNP Platforms
Speaker Presentation: Consultants' Network September 2025Lemercier Jean-Noel, Editas Medicine, Inc., …
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Look Up or Don’t Look Up? A Deep Dive into Bioassay Data Analysis
Speaker Presentation: Consultants' Network June 2025Stetsenko Anton, BioQual Consulting LLC, 2025
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Case Examples of CMC Surprises
Speaker Presentation: Consultants' Network June 2025Sharokh Zahra, STC Biologics, 2025
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Black Box, Fantasy, or Gödel’s Knot? Why Mass Spectrometry in Biopharma is None of These
Speaker Presentation: Consultants' Network March 2025Skilton St John, Protein Metrics, LLC, 2025
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Case Study:
Investigating
Monoclonal Antibody
Fragmentation Issues
Speaker Presentation: Consultants' Network March 2025Schenerman Mark, CMC-MAS Biotech, 2025
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I Want to Start a New Consulting Business, What Should I Do?
Speaker Presentation CASSS Consultants' NetworkEgodage Kamal, Lasanth Consulting, 2024
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Operational Aspects of Medical Product Consulting
Speaker Presentation CASSS Consultants' NetworkMoore Edwin, Biophia Consulting Inc., 2024
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I Want to Start a New Consulting Business, What Should I Do?
Speaker Presentation CASSS Consultants' NetworkCash Patricia, Independent Biotechnology Consultant, …
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Common Gaps in BLA Packages for QC Release and Stability Method Validations
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Speaker Presentation Ritter Nadine, Global Biotech Experts, LLC, 2024 -
Overview of ICH Q2(R2)/Q14:
Development and Validation of Analytical Procedures
Speaker Presentation Cauchon Nina Amgen Inc. and Pelletier Mary Beth Biogen 2023