Gain insight from industry experts, academic researchers, and expert regulatory authorities as they explore new technologies, best practices, and how to design an efficient manufacturing process.
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Usefulness/applicability of Virus Co-spiking in virus clearance study | Yukichi Hatano, MSc, Bioprocess Unit Manager (Associate Director), JCR Pharmaceuticals
Adapting Virus Filtration Operation to Continuous Processing Challenges | Christine Stouffer, Senior Research Associate, Asahi Kasei Bioprocess
The FDA's Reference Viral Database | Pei-Ju Chin, MS, PhD, Staff Fellow, US Food and Drug Administration
Understanding the Challenges and Guidelines of Cell and Gene Therapy within Viral Clearance | Tareq Jaber, Associate Director, Process Evaluation, Charles River
New Insights into Low pH Viral Inactivation | Etienne Utiger, Scientist, AstraZeneca
Utilizing Viral Surrogates to Evaluate Viral Clearance for Multiple Modes of Separation | David A. Cetlin, Senior Director of R&D, Cygnus Technologies
Strategizing Digital Transformation of Viral Clearance Database | Melissa Nathlich, Process Development Associate Scientist, Amgen
Accelerating Viral Clearance Studies: A Co-Virus Spike Approach | Madison Gaiser, Viral Clearance Associate Scientist, Charles River
Anion Exchange in Viral Clearance for Biologics: A Comparison of Membrane Chromatography and Column Chromatography | Paul Phelan, Principal Scientist in Downstream Process Development, Joinn Biologics
Viral Clearance of IsoBlock Membranes and its Dependence on Surface Chemistry | Daniele Gerion, Senior Director of R&D, TeraPore Technologies
Examining the Effects of Variable Pressure Conditions on Viral Clearance of Planova Filters | Tsion Akalu, Field Applications Scientist, Asahi Kasei Bioprocess America, Inc.
Efficient Virus Inactivation for Acid-Sensitive Proteins Using an Ecofriendly Amine N-Oxide-Based Detergent | Nora Roos, PhD, Process Engineer DSP, Rentschler Biopharma
Current Approaches and Considerations for Viral Clearance in Cell and Gene Therapy (CGT) | Tareq Jaber, PhD, Associate Director, Process Evaluation, Charles River
Viral Safety & NGS Review of Current NGS Related Regulations and its Meaning for NGS Acceptance | Horst Ruppach, PhD, Executive Director, Scientific and Portfolio, Global Biologics, Charles River
Next-Generation Minute Mouse Virus (MMV) Stock Impact on Small-Scale Viral Filter Performance | Alyssa Lovullo, Scientist, Biosafety Development (BSD), Amgen
Analysis Matters: Practical Bioinformatics for NGS-based Virus Safety Testing | Shawn Polson, Associate Professor, Computer and Information Sciences and Plant and Soil Sciences, University of Delaware
Head-to-Head Comparison of NGS and In Vivo Viral Safety Testing: A Short Summary of the Publication | Horst Ruppach, Executive Director, Scientific and Portfolio, Biologics Solutions, Charles River
GMP is Not for the Faint of Heart | Colette Côté, PhD Chief Portfolio Officer and General Manager, US, PathoQuest
Viral Clearance & Viral Safety Q&A with Industry & Regulatory Experts
Moderated by: Horst Ruppach, PhD, Executive Director, Scientific and Portfolio, Global Biologics, Charles River
Panelists:
Jens Modrof, PhD, Director Operations Global Pathogen Safety, Takeda
Denise Teber, PhD, Scientific Expert PCR, Impurity Testing, Charles River
Karl Bertram, PhD, Co-Founder and Managing Director, ATEM Structural Discovery
Astrid Schwantes, PhD, Scientific Assessor, Paul Ehrlich Institute
Amina Cherif Louazani, PhD, Viral Safety and Regulatory Affairs Manager, PathoQuest