Tag: recombinant Factor C (rFC)

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Featured image for Pharmeuropa 38.2 draft updates showing regulatory documents and GMP Insiders branding.

Pharmeuropa 38.2: New Drafts Released for Public Consultation

Pharmeuropa 38.2 introduces draft revisions to bacterial endotoxin testing, particle-size analysis, and sieve chapters, with comments open until 30 June...
Ph.Eur. Proposes rFC Endotoxin Test Integration and Pyrogen Testing Updates

Ph. Eur. Proposes rFC Endotoxin Test Integration and Pyrogen Testing Updates

Ph. Eur. adds rFC to BET (2.6.14) and updates pyrogen testing (5.1.13) to support sustainable, animal-free methods in line with...
USP Introduces New Chapter for Early Adoption Non-Animal Derived Endotoxin Testing Methods

USP Introduces Chapter <86> Bacterial Endotoxins Test Using Recombinant Reagents for Early Adoption

USP releases early adoption guidelines for non-animal endotoxin testing, promoting sustainable recombinant Factor C methods with strict validation standards....

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