Course Description:This course provides an in-depth examination of the Bacterial Endotoxins Test (BET) using recombinant reagents. Participants will gain a comprehensive understanding of the significance of endotoxin testing in ensuring product safety and compliance with regulatory standards.
The course begins with an overview of bacterial endotoxins, their sources, and their implications for human health. It highlights the importance of accurate endotoxin detection in pharmaceutical products, particularly those administered parenterally. Participants will learn about the advantages of using recombinant reagents, such as recombinant Factor C (rFC) and recombinant cascade reagents (rCR), which offer a non-animal-derived alternative to traditional testing methods.
Participants will explore the methodologies involved in performing the BET using recombinant reagents. This includes preparation of standard endotoxin solutions, execution of both fluorometric and chromogenic techniques, and interpretation of results.
The course will also address current regulatory requirements and best practices for incorporating recombinant reagents for endotoxin testing, equipping participants with the knowledge to navigate compliance challenges effectively.
Upon completion of this course, you will be able to:
- Define bacterial endotoxins and explain their significance in pharmaceutical testing.
- Identify and describe the recombinant reagents and testing techniques used in BET.
- Identify and explain current regulatory requirements for endotoxin testing using recombinant reagents.
- Implement testing methods for products that have a monograph requirement for BET.
Who should participate:
pharmaceutical microbiologists, quality control (QC) scientists, quality assurance (QA) professionals, and regulatory affairs specialists