Calculating and Setting Endotoxin Limits for Drug Products, Biologics and Formulation Components

This course describes the derivation and application of the concept of an endotoxin limit, and provides discussion on the importance of endotoxin limits and how the limits might change during a drug’s life cycle. The course content relies heavily on the use of examples to demonstrate how endotoxin limits can change with the indications and administration of drug products and examines the effect of APIs and excipients on the endotoxin content of a drug product.

Online Course September 26th 2023 at 9:30am - 1:00pm EDT

Karen Zink McCullough

Owner, Principal Consultant at MMI Associates

Karen Zink McCullough is the managing member and principal consultant at MMI Associates LLC, a firm focusing on GMP and Microbiology in the drug, biologics, cell therapy, and medical device industries, with a speciality in the Bacterial Endotoxins Test (BET). Ms. McCullough was the first to publish on the use of the BET as a replacement for the rabbit pyrogen test for small volume parenterals. She has published over 50 articles and book chapters, and is the editor of the book, “The Bacterial Endotoxins Test: A Practical Guide.” She is a well respected international speaker on GMP and the BET. Ms. McCullough is chairperson of the LAL Users’ Group, is a United States Representative to Working Group 2, TC 209 for the revision of ISO 14698, and is a former member of the United States Pharmacopeia Expert Committee on Microbiological General Chapters. She holds a Bachelor’s degree in Bacteriology from Rutgers University and a Master’s degree in Molecular Biology from the University of Oregon

Learning Objectives:

Upon completing this course the participants will understand:

• Understand the derivation of the endotoxin limit
• Understand the basic endotoxin limit calculation
• Calculate the endotoxin limit for different products (injections, infusions, biologics, small molecules)
• Assigning endotoxin limits to formulation components
• Assigning endotoxin limits to testing accessories
• Understanding endotoxin limits and product lifecycle

Who will benefit: 

• Laboratory Analysts
• Laboratory Managers
• CMC Managers
• Quality System Managers
• Regulatory Affairs professionals

Industries Benefited:

· Pharmaceutical
· Biopharmaceutical
· Biologics including cell and gene therapies
· Contract Facilities (CDMO)

Course Schedule:

9:30 to 1:00pm EDT

• Welcome. Derivation of the endotoxin limit and application to calculating limits for drug products (1.5 hours)
• Assigning endotoxin limits to formulation components and testing accessories (1 hour)
• Endotoxin Limits and the Product Lifecycle; Summary of the Course (0.5 hours)

Questions and Answers Session

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