ACC’s APR Endotoxin Supplements

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

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 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 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 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 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.