Endotoxin control of pharmaceutical API and biopharmaceutical drug substances or API production processes is a significant quality and compliance problem today.
Endotoxin, a cell wall component of gram negative bacteria, can cause varying levels of immune responses when introduced to the blood system. As a result, the onus is on the manufacturers of all parenteral drugs to control possible endotoxin contamination throughout the manufacturing process. As pharmaceutical manufacturing processes continue to become more streamlined and new therapy delivery continues to evolve, endotoxin control is evolving as well.
The 2018 PDA Endotoxins Workshop will provide scientific understanding and real-world practices for endotoxin testing in bio/pharmaceutical production processes.
Major topics to be covered will include:
Academic Perspectives on Immune Response to endotoxins
Low Endotoxin Recovery (LER)
Data Integrity
Beta-Glucans: Practical Issues Associated with Pharmaceutical Manufacturing
Non-LAL based endotoxin detection methods
BET Laboratories: Practical Advice
This Workshop will present practical approaches to endotoxin testing that participants can use in daily work and laboratory operations.
Learning Objectives
Upon completion of this Workshop, you will be able to:
Understand complex interaction of endotoxins with immune system.
Describe best practices for your company’s approach to address LER
Identify the best test method for endotoxin analysis for your company’s purpose
Recognize possible inhibitors and enhancers of the LAL test
Select appropriate endotoxin specifications for your company’s products
Describe best practices for your company’s new or existing laboratories
Who Should Attend
Department
Biochemistry | Biology | Manufacturing | Microbiology | Development | Quality | Regulatory Affairs | Research | Technical Operations | Validation
Job Function
Biologist | Microbiologist | Operator/Technician | Pharmacist | Product Manager | Scientist/Researcher
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