Outlining the most common comments from drug manufacturers, the Parenteral Drug Association (PDA) and US Food and Drug Administration (FDA) on the USP draft chapter for recombinant Factor C ().
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The new chapter describes a method for bacterial endotoxins (BET) testing using recombinant factor C (rFC) instead of limulus amoebocyte lysate (LAL).
The Sievers Eclipse* Bacterial Endotoxins Testing (BET) Platform empowers users to be conscious of today’s needs to protect valuable natural resources while still complying with the strict analytical and regulatory requirements drug and device manufacturers must meet.
For over 30 years, pharmaceutical and medical device product release has relied solely on endotoxin assays using Limulus Amebocyte Lysate (LAL). This article addresses the potential risks associated with relying on a single raw material in a fragile supply chain and explores alternative testing options.
To fulfil the need for compliant, efficient endotoxin testing that the horseshoe crab population can sustain, SUEZ introduces the Sievers Eclipse Bacterial Endotoxins Testing (BET) Platform.
As the pioneers of the Limulus amebocyte lysate (LAL) testing methodology, Associates of Cape Cod, Inc. (ACC) specialises in bacterial endotoxin and (1→3)-ß-D-glucan detection, using US Food and Drug Administration-licensed chromogenic, turbidimetric and gel-clot reagent technologies.
The recombinant Factor C (rFC) assay has been developed to help alleviate the pressures of a growing demand for the Limulus amoebocyte lysate (LAL) assay. Here, Sven Deutschmann and Johannes Reich discuss the advantages of rFC and its recent recognition by the European Pharmacopoeia as an alternative endotoxin test.
With Recombinant Factor C (rFC), we’re making Endotoxin testing faster, easier and more ecologically friendly by mimicking nature, not exploiting it.
Changes to lab setups become necessary for many reasons, but the important role of quality control should remain consistently accurate. Tim Sandle and Kerry Skinner describe the details to consider when transferring an analytical method between laboratories or when changing your reagent supplier.
Testing for pyrogens is a critical step in ensuring the safety of parenteral pharmaceutical products and medical devices.
As the pioneers of the Limulus amebocyte lysate (LAL) testing methodology, Associates of Cape Cod, Inc. (ACC), specialises in bacterial endotoxin and (1→3)-ß-D-glucan detection, using FDA-licensed chromogenic, turbidimetric and gel-clot reagent technologies.
Nelson Labs has a long history of partnering with pharmaceutical and biopharmaceutical companies. We perform a variety of testing to support your internal quality processes including: sterility (USP 71) testing in a cleanroom for isolator environment, particulates testing (USP 787, 788) using a variety of methods, bacterial endotoxin, filter validations,…