The Importance of the Standard Curve for Quantitative Endotoxins Testing

Every analytical method is subject to variability. For photometric (quantitative) endotoxin assays the quality of the standard curve, is perhaps the greatest variable of all. Although the only current compendial “requirement” for the standard curve is linearity, this webinar will demonstrate the impact that not only non-linearity but also changes in slope and y-intercept can have on the quality of the curve and ultimately the accuracy of the test result.  

Online Course February 28th 2023 at 8:30am - 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: 

• Description of the evolution of photometric methods
• Construction of the standard curve – dilutions, range
• The impact of linearity, slope and y-intercept on the accuracy of test results
• What is the experimental error of a photometric method?
• Managing standard curve variability

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. History of the development of photometric assays
• Constructing a standard curve
• Impact of standard curve quality on the accuracy of test results
• What is the experimental error of the photometric assays?
• Managing variability

Questions and Answers Session

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