ACC’s APR Endotoxin Supplements
Endotoxin Detection Part XI
- Endotoxin Detection Part XI: Ahead of the Curve
Testing Colored Samples, Validation Process - Recombinant Cascade Reagent (rCR), The Horseshoe Crab Population and Automation Solutions for BETA
A Supplement to American Pharmaceutical Review - The Myth of Testing Colored Samples: Debunked
Global Technical Services Team - Associates of Cape Cod, Inc. - Report: A Demonstration of the Validation Process for Alternative Endotoxin Testing Methods Using PyroSmart NextGen® Recombinant Cascade Reagent
Madeline Kelley et. al. - The Future Of Bacterial Endotoxin Testing
- The Impact of Biomedical Use of Horseshoe Crabs - Post Pandemic Update
Brett Hoffmeister - Use of the Andrew+ Robot and OneLab Automated Liquid Handling Platform for Bacterial Endotoxin Testing
Robert D’Ordine, Ph.D.
Endotoxin Detection Part X
- Endotoxin Detection Part X:
Moving Forward with Accurate and Sustainable Endotoxin Testing to Meet Global Standards
A Supplement to American Pharmaceutical Review - Horseshoe Crabs and The Biomedical Industry... Know The Truth - FAQs
- Will a Proposed Reduction in Endotoxin Limits for Drugs and Biologics Improve Patient Safety?
James E. Akers, PhD et. al. - Development and Qualification Factors for Endotoxin Removal from Proteins Using Chromatographic Columns
Dr. Tim Sandle, PhD - Opinion: Reflections on Testing Medical Devices— Is it Time for an Update?
Karen Zink McCullough - Interview With Veronika Wills - Manager, Technical Services, Associates of Cape Cod, Inc.
- European Pharmacopoeia Approach to Testing for Pyrogenicity
Emmanuelle Charton, PhD - PyroSmart NextGen® rCR Comparability Studies
- The Truth of Endotoxin Values
Points for Consideration During Investigation of Aberrant BET Results
Johannes Delp et. al.
Endotoxin Detection Part IX
- Endotoxin Detection Part IX:
Current Issues And Future Considerations for Pyrogen-Free Products
A Supplement to American Pharmaceutical Review - Sustainability in Bacterial Endotoxin Testing (BET) – A Holistic Approach to Conservation and Recombinant Technology
Veronika S. Wills - Interview With Brett Hoffmeister - LAL Production Manager, Associates of Cape Cod, Inc.
- Functional Challenges for Alternative Bacterial Endotoxins Tests Part 4: Beyond Recombinant Reagents
James A. Akers et. al. - Novel Aptasensors for Endotoxin Detection Are Advancing Drug Discovery
Tim Sandle, PhD - COVID-19’s Impact on The Sustainability of the LAL Supply and Horseshoe Crab Population
Brett Hoffmeister et. al. - Validation Strategies for Gel-Clot Bacterial Endotoxin Testing
Crystal M. Booth, M.M.
Endotoxin Detection Part VIII
- HORSESHOE CRABS AND THE BIOMEDICAL INDUSTRY... Know the Truth
- Historical Milestones and Industry Drivers in the Development of Recombinant Lysate for Bacterial Endotoxin Testing
Tim Sandle - Functional Challenges for Alternative Bacterial Endotoxins Tests - Part 1: Attributes for Alternative Tests
James Akers et. al. - Functional Challenges for Alternative Bacterial Endotoxins Tests - Part 2: Comparability
James Akers et. al. - Functional Challenges for Alternative Bacterial Endotoxins Tests - Part 3: The Centrality of Autochthonous Endotoxins in the Assurance of Patient Safety
James Akers et. al.
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