APR Endotoxin Supplements

The Benefits of Recombinant Cascade Reagents for Endotoxin Detection
A Supplement to American Pharmaceutical Review

rCR Implementation Guide
A Supplement to American Pharmaceutical Review

Bacterial Endotoxins Testing Using Non-Animal Derived Reagents and Innovative Microfluidic Technology on Real World Samples
Jay Bolden, Kelly Smith, Eli Lilly

Drivers of Implementation of Recombinant Technologies for Endotoxin Testing 
A Supplement to American Pharmaceutical Review

Beyond LAL: Next-Gen Recombinant Methods for Endotoxin Testing
A Supplement to American Pharmaceutical Review

Endotoxin Detection Part XI: Ahead of the Curve
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
A Supplement to American Pharmaceutical Review

The Impact of Biomedical Use of Horseshoe Crabs
Brett Hoffmeister

Use of the Andrew+ Robot and OneLab Automated Liquid Handling Platform for Bacterial Endotoxin Testing
Robert D’Ordine, PhD

Endotoxin Detection Part X
A Supplement to American Pharmaceutical Review

Horseshoe Crabs and The Biomedical Industry... Know The Truth
Associates of Cape Cod, Inc.

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
Associates of Cape Cod, Inc.

European Pharmacopoeia Approach to Testing for Pyrogenicity
Emmanuelle Charton, PhD

PyroSmart NextGen^® rCR Comparability Studies
Associates of Cape Cod, Inc.

The Truth of Endotoxin Values
Johannes Delp et. al.

Endotoxin Detection Part IX
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
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

Horseshoe Crabs and The Biomedical Industry... Know The Truth
Associates of Cape Cod, Inc.

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
James Akers et. al.

Functional Challenges for Alternative Bacterial Endotoxins Tests - Part 2
James Akers et. al.

Functional Challenges for Alternative Bacterial Endotoxins Tests - Part 3
James Akers et. al.

Clinical Evidence for the Suitability of Current Bacterial Endotoxin Testing
James E. Akers, PhD

“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, PhD

The Impact of Biomedical Use of Horseshoe Crabs
Mick Dawson, Brett Hoffmeister

Endotoxin Testing as a Detection Method for Bacterial Biofilms
Tim Sandle

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, Brett Hoffmeister

Sanofi Holistic Risk-Based Approach to Low Endotoxin Recovery (LER)
Mark Kapeckas, Marine Marius, Jon Williams

Setting Endotoxin Acceptance Criteria for Biologics Intravenous (IV) and Subcutaneous (SC) Mono- and Combination Therapies
Friedrich von Wintzingerode, PhD et. al.

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

(1-->3)-ß-D-Glucan: Pharmaceutical Contaminant and Biological Response Modifier
Malcolm Finkelman, PhD

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, PhD

Rapid Bacterial Endotoxin Testing (BET)
Veronika Wills

Removal of Endotoxin from Protein in Pharmaceutical Processes
Tim Sandle

Bioburden Contamination Control: A Holistic Overview
Scott Sutton, PhD

Endotoxin Detection Methods – Where are we now?
Kalavati Suvarna, PhD

European Sterile Products Guidance Under Review
Tim Sandle

Implementation of a Rapid Endotoxin Testing Platform
Jeffrey Weber, Gerard Ryan Jr., Susan Berlam

LER Frequently Asked Questions
Karen Zink McCullough

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., 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, PhD

A Comparative Study of Different Methods for Endotoxin Destruction
Tim Sandle, PhD

Creation of an In-house Naturally Ocurring Endotoxin Preparation for Use in Endotoxin Spiking Studies and LAL Sample Hold Time Analysis
Kim Bowers, Lynn Johnson

An Interview with Michael E. Dawson, Ph.D., RAC
Associates of Cape Cod, Inc.

Recent Regulatory Issues Concerning Bacterial Endotoxin Testing
Michael E. Dawson, PhD, RAC

The Bacterial Endotoxins Test – Back to the Future
Karen Zink McCullough