ACC’s APR Endotoxin Supplements
Endotoxin Detection Part VII
- Clinical Evidence for the Suitability of Current Bacterial Endotoxin Testing
James E. Akers, Ph.D. - “Fit For Purpose” Endotoxin Analytes
Karen Zink McCullough - A Summary of USP’s Workshop on “The Future of Endotoxins and Pyrogen Testing: Reference Standards and Procedures”
Radhakrishna S. Tirumalai, Ph.D. - The Impact of Biomedical Use of Horseshoe Crabs
Mick Dawson and Brett Hoffmeister - Endotoxin Testing as a Detection Method for Bacterial Biofilms
Tim Sandle
Endotoxin Detection Part VI
- Calculating Endotoxin Limits for Drug Products
Karen Zink McCullough - Endotoxin Testing as a Detection Method for Bacterial Biofilms
Tim Sandle - The Impact of Biomedical Use on Horseshoe Crabs
Mick Dawson and Brett Hoffmeister - Sanofi Holistic Risk-Based Approach to Low Endotoxin Recovery (LER)
Mark Kapeckas, Marine Marius, and Jon Williams - Setting Endotoxin Acceptance Criteria for Biologics Intravenous (IV) and Subcutaneous (SC) Mono- and Combination Therapies
Friedrich von Wintzingerode, PhD. et. al.
Endotoxin Detection Part V
- Adaptation
Karen Zink McCullough - Assessment of Bacterial Endotoxin by Fluorescent Labeling
Tim Sandle - Serum: A Better Characterized Biological
Rosemary J. Versteegen BSc, PhD - Setting Endotoxin In-Process Controls For Recombinant Therapeutic Proteins
Friedrich von Wintzingerode, PhD - The United States Pharmacopeia and Depyrogenation
Michael E. Dawson, PhD, RAC and Veronika Wills, MS
Endotoxin Detection Part IV
- (1-->3)-ß-D-Glucan: Pharmaceutical Contaminant and Biological Response Modifier
Malcolm Finkelman, Ph.D. - Current USP Perspectives on Low Endotoxin Recovery (LER)
Karen Zink McCullough - Naturally Occurring Endotoxin: A New Reference Material Proposed By the US Pharmacopeia
Radhakrishna S. Tirumalai, Ph.D. - Rapid Bacterial Endotoxin Testing (BET)
Veronika Wills - Removal of Endotoxin from Protein in Pharmaceutical Processes
Tim Sandle
Endotoxin Detection Part III
- Bioburden Contamination Control: A Holistic Overview
Scott Sutton, Ph.D. - Endotoxin Detection Methods – Where are we now?
Kalavati Suvarna, Ph.D. - European Sterile Products Guidance Under Review
Tim Sandle - Implementation of a Rapid Endotoxin Testing Platform
Jeffrey Weber, Gerard Ryan Jr. and Susan Berlam - LER Frequently Asked Questions
Karen Zink McCullough
Endotoxin Detection Part II
- Are You Smarter than a Fifth Grader? (Bacterial Endotoxins Version)
Karen Zink McCullough - Endotoxin Test Concerns of Biologics Part II: Developing New Tools
Kevin L. Williams - Implementation of a Rapid Endotoxin Testing Platform
Jeffrey Weber, Gerard Ryan Jr. and Susan Berlam - Low Lipopolysaccharide Recovery versus Low Endotoxin Recovery in Common Biological Product Matrices
Cheryl Platco - Variability and Test Error with the LAL Assay
Tim Sandle, Ph.D.
Endotoxin Detection Part I
- A Comparative Study of Different Methods for Endotoxin Destruction
Tim Sandle, Ph.D. - Creation of an In-house Naturally Ocurring Endotoxin Preparation for Use in Endotoxin Spiking Studies and LAL Sample Hold Time Analysis
Kim Bowers and Lynn Johnson - An Interview with Michael E. Dawson, Ph.D., RAC
- Endotoxin Test Concerns of Biologics Part I
Kevin L. Williams - Recent Regulatory Issues Concerning Bacterial Endotoxin Testing
Michael E. Dawson, Ph.D., RAC - The Bacterial Endotoxins Test – Back to the Future
Karen Zink McCullough