COVID-19 Immune Globulin Regulation
Dorothy Scott, MD
Branch Chief for the Laboratory of Plasma Derivatives, Office of Blood Research and Review, US FDA, Center for Biologics Evaluation and Research
Download PDF
SARS-CoV-2 Inactivation by Commonly Available Chemicals on Inanimate Surfaces
Eleonora Widmer, MD, PhD
Senior Director Global Pathogen Safety, CSL Behring
Download PDF
Decontamination of N95 Respirators in a Large Hospital System in the COVID-19 Emergency
Ebru Oral, PhD
Associate Professor of Orthopedic Surgery Harvard Medical School, Associate Director at Harris Orthopedic Lab at Massachusetts General Hospital, Fellow of the National Academy of Inventors
Developing and Implementing Viral Safety Strategies for Cell and Gene Therapy
David Hambly, PhD
President, Advanced Therapy Product Consulting, Inc.
Download PDF
Detection of Replication Competent Viruses in Viral Vector Products
Matthew Pennington, PhD
Scientist 1, Virology Department, Charles River
Download PDF
Testing for Replication Competent Viruses in Retroviral and Lentiviral Vector Products
Kenneth Cornetta, MD
Clinical Professor of Medical and Molecular Genetics, Indiana University School of Medicine Director, National Gene Vector Biorepository, Associate Director, Brown Center for Immunotherapy
Download PDF
Viral Safety in Continuous Manufacturing
Scott Lute, PhD
Biologist/Research Reviewer, Center for Drug Evaluation and Research, U.S. Food and Drug Administration
Download PDF
Points to Consider for the Development of a Virus Inactivation Process
Jens-Peter Gregersen, DVM, PhD
Independent Biomedicines Consultant
Download PDF
Confronting Antigenic Diversity with Broad-Strain Vaccines
Christopher Locher, PhD
CEO, Versatope Therapeutics, Inc.
Download PDF
Current Perspectives on NGS for Adventitious Virus Detection
Arifa Khan, PhD
Senior Investigator in the Office of Vaccines Research and Review, U.S. Food and Drug Administration, Center for Biologics Evaluation and Research
Download PDF
Evaluation of RNA Next Generation Sequencing (Transcriptomics Analysis) to Replace In Vivo Tests for Assessing the Viral Safety of Cells
Horst Ruppach, PhD
Scientific and Portfolio Director, Global Biologics Charles River
Mark Eloit, DVM, PhD
Founder & Scientific Advisor, Pathoquest
Download PDF
Biotech Viral Safety: New Opportunities and Current Trends in Viral Clearance and Safety
Kurt Brorson, PhD
Vice President, Technical, Parexel
Download PDF
Decontamination of PPE via Vaporized Hydrogen Peroxide and Moist Heat Treatment
Cassidy Collins
Senior Technician, Process Evaluation, Charles River
Exploration of Production Conditions to Achieve High Titer Influenza A
Janalyn Frederick
Senior Technician, Process Evaluation, Charles River
Madison Gaiser
Technician 2, Process Evaluation, Charles River
Gene Therapy Studies (AAV Vector): Viral Clearance Challenges
Amanda Budzilowicz
Senior Technician, Process Evaluation, Charles River
Viral Clearance for Medical Devices (Case Study)
Crystal Reitman
Senior Technician, Process Evaluation, Charles River
Evaluating Effects of Pressure Fluctuations by Constant Flow Method on Viral Clearance
Esha Vyas
Field Applications Manager, Asahi Kasei Bioprocess America, Inc.