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USP Provides Guidelines for rFC Reagent

Recombinant Factor C critical to development of vaccines and other sterile pharmaceutical products.

By: Contract Pharma

Contract Pharma Staff

The U.S. Pharmacopeia (USP) published a Compendial Notice and Prospectus regarding the introduction of recombinant Factor C (rFC) – a synthetic alternative to naturally sourced reagents derived from horseshoe crabs – into the official text of the USP-NF. This latest step is part of an effort to introduce more methods for detection of bacterial endotoxins, an important early step in the process for vaccine development and other injectable therapeutics. USP is also making draft guidelines on ...

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