USP has announced an upcoming workshop in Maryland to address the challenges faced by industry, regulators, and other stakeholders regarding endotoxin and pyrogen testing.
The workshop, Future of Endotoxins and Pyrogen Testing: Reference Standards and Procedures Workshop, will take place June 10-11 at the USP Meeting Center, Rockville, MD.
The production of parenteral products requires not only that products be sterile, but that they are also free from harmful levels of pyrogens. Bacterial endotoxins, components of the gram-negative bacterial cell wall, comprise the vast majority of pyrogens found in parenteral manufacturing. USP's Microbiology Expert Committee is hosting this workshop to address practical and science-based issues evolving in endotoxin and pyrogen testing. The purpose of this workshop is to consider new endotoxin and non-endotoxin pyrogen reference materials and new endotoxin and pyrogen test methods. To encourage active stakeholder / audience participation, the workshop will follow a unique format with brief talks followed by longer roundtable discussions on each of the topics.
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Objectives
- Engage stakeholders and provide background on USP’s effort to consider the development of a new reference standard for endotoxins and its potential applications in overcoming test interferences and depyrogenation
- Discuss experimental design for spike recovery studies and how they can be made more representative of product manufacturing conditions
- Examine the implementation of alternate test methods for endotoxin testing
- Review current strategies for and challenges with using alternate in vitro methods and non-endotoxin reference standards for pyrogen testing
Who Should Participate
- Quality Assurance/Quality Control Specialists
- Regulators & Regulatory Affairs Professionals
- Research and Development Scientists, Engineers
- Contract Research Organizations
- Contract Manufacturing and Testing Organizations
Registration and additional information will be available in late February. Click here for more information.