Current Status and Overview of the Rapid Microbiological Methods and Endotoxin Microbiology USP Chapters under Development
An Overview of Recent USP Bacterial Endotoxins Standards Development
Detection of bacterial endotoxins is a critical quality attribute of parenteral pharmaceuticals and medical devices. Bacterial endotoxins are cell wall components of Gram-negative bacteria, ubiquitous in nature, difficult to destroy and can cause pyrogenic responses or worse.
We are at a generational change in bacterial endotoxins test method options. Creating the infrastructure to enable broader use of recombinant reagents advances the science while maintaining the safety and quality of medicines. Recombinant reagents are derived from established biotechnology principles which begin with the same mechanism of action as the natural protein derived from horseshoe crabs; the detection of bacterial endotoxins by the Factor C protein. Recombinant reagents also afford improvements in quality, supply chain, and sustainability.
The USP Microbiology Endotoxin and Pyrogens Subcommittee developed a recombinant reagent bacterial endotoxins test chapter which is based on the underlying science, and data from the peer-reviewed literature, sponsor and supplier validations, and ring study trials.
Watch this webinar to learn more about the following presentations:
- Overview and Future Plans of the USP Rapid Microbiological Methods Subcommittee - Presented by Dr David Roesti, PhD. Microbiologist/Facilitator QA/QC at Novartis Pharma AG.
- Early Implementation of Recombinant Cascade Reagent PyroSmart NextGen® in Line With USP <86> - Presented by Veronika Wills, Manager, Technical Services at Associates of Cape Cod, Inc.
- A 3-Step Validation Blueprint for Recombinant Method Implementation – Presented by Nicola Reid, Associate Director of Endotoxin Products, Charles River.
- Early detection of microbial contaminants in cell-based products using the Milliflex® Rapid System – Presented by Jamin Jallow, Microbiology Technology Specialist at Merck KGaA.
- Implementation of BACT/ALERT® 3D in light of the USP <72> Chapter: Respiration-Based Microbiological Methods for the Detection of Contamination in Short-Life Products – Presented by Félix Montero-Julian, Scientific Director of Pharma Quality Control at bioMérieux.
