References and Resources — ISIA

References and Resources

Dr. Rosemary Versteegen - ISIA CEO, Nicole Green, Judith Pogoda-Leone, Raymond Nims
Heat Treatment As A Risk Management Tool
Dr. Rosemary Versteegen - ISIA CEO, Mark Plavsic, Raymond Nims, Robert Klostermann, Karl Hemmerich
Gamma Irradiation of Animal Serum: An Introduction
Mark Plavsic, Raymond Nims, Marc Wintgens, Dr. Rosemary Versteegen
Gamma Irradiation of Animal Serum: Validation of Efficacy for Pathogen Reduction and Assessment of Impacts of Serum Performance
Bart Croonenborghs, Andy Pratt, Lorraine Bone, and Mara Senescu
Gamma Irradiation of Frozen Animal Serum: Dose Mapping for Irradiation Process Validation
Sue Brown, Bart Croonenborghs, Kevin Head, Mara Senescu, Raymond Nims, Mark Plavsic, and Dr. Rosemary Versteegen
Gamma Irradiation of Animal Serum: Maintaining the Cold Chain Throughout the Process
Karl Hemmerich, Randy Fitzgerald, Dennis Hallett, Raymond Nims, and Dr. Rosemary Versteegen
Gamma Irradiation of Animal Serum: Theoretical Basis of Impacts of Gamma Irradiation on Biological and Synthetic Polymers
Greg Hanson, Bart Croonenborghs, Mara Senescu, Huw Huges, Raymond Nims, and Dr. Rosemary Versteegen
Gamma Irradiation of Animal Serum: General Regulatory Environment and Process Controls

Fetal Bovine Serum – Common Attributes as a Verification of Geographical Origin
Dr. Rosemary J. Versteegen, Brian Douglass, Jenny Murray, and Nicole Green
Is your serum a forgery? The painful truth about the importance of the origin of Fetal Bovine Serum (FBS) in research
Jenny Murray, Dr. Rosemary J. Versteegen
Fetal Bovine Serum - Geographical Origin and International Trade
Jenny Murray A Challenging Future for Fetal Bovine Serum
Dr. Rosemary Versteegen Serum: A Better Characterized Biological
Dr. Rosemary Versteegen Serum: What, Where, & When
William Siegel Fetal Bovine Serum: Risk Management
Percy Hawkes Fetal Bovine Serum: Geographic Origin and Regulatory Relevance of Viral Contamination
William Siegel and Leland Foster Fetal Bovine Serum: The Impact of Geography
Devin Davis and Sherrie Drake Hirschi Fetal Bovine Serum: What You Should Ask Your Supplier and Why

Publications of Interest

Dr. Rosemary Versteegen, Dr. Sam Lind, Dr. Olya Shatova, Kate Linterman
Testing for Geographic Origin of Fetal Bovine Serum
Steven Doelger, Lisa Orfe, Michelle Cheever, Randy Fitzgerald, Greg Hanson, Dr. Rosemary J. Versteegen
BVDV Risk Mitigation: Dealing with Bovine Viral Diarrhea Virus in Serum
Michelle Cheever, Alyssa Master, and Dr. Rosemary Versteegen
A Method for Differentiating Fetal Bovine Serum from Newborn Calf Serum

MN. Jacobs, JM. Bult, K. Cavanagh, C. Chesne, N. Delrue, J. Fu, E. Grange, I. Langezaal, D. Misztela, J. Murray, M. Paparella, G. Stoddart, T. Tonn, C. Treasure, M. Tsukano, R. Versteegen
OECD workshop consensus report:Ethical considerations with respect to human derived products, specifically human serum, in OECD TGs
Dr. Rosemary Versteegen, Jenny Murray, Steven Doelger
Animal Welfare and Ethics in the Collection of Blood for the Production of Fetal Bovine Serum
Miriam Jacobs, Dr. Rosemary Versteegen, Carol Treasure, Jenny Murray
Addressing potential ethical issues regarding the supply of human-derived products or reagents in in vitro OECD Test Guidelines
Ole Bodtker Nielson and Percy W. Hawkes
Animal Welfare and Ethics

ISIA Traceability Certification vs ISO Certification
Nicole Green
ISIA Traceability Certification FAQs
Nicole Green
Geographic testing for FBS: How and Why?
Dr. Sam Lind
Traceability Certification
Nicole Green, Dana Lynch, Andres Monroy, Kent Treichler

Educational Modules

Animal Product Guidance – Part 1
Martina Pomper, Melanie Sorenson
Animal Product Guidance – Part 2
Martina Pomper, Melanie Sorenson
Import/Export Best Practices
Melanie Hill, Angie Johnson, Steve Doelger

Comparison of The Efficacy of Barrier Treatments for Viral Risk Mitigation in Human vs Bovine Serum
Dr. Raymond Nims
What to look for on a Certificate of Analysis
Lisa Orfe
Gamma Irradiation and Heat Inactivation Comparison
Dr. Rosemary Versteegen, Nicole Green

Fireside Chat with Robyn Kisrow, the New CEO of ISIA
Robyn Kirsow

Position Papers

Freezing and Thawing of Serum

Heat Treatment as a Risk Management Tool

Nitrosamines

PCR Testing

Recommended Wording to Replace USDA and EU Approved