A New Solution for Recombinant Factor C Endotoxin Testing
BioMérieux SPONSORED CONTENT

A New Solution for Recombinant Factor C Endotoxin Testing

The vast majority of endotoxin tests for pharmaceuticals and medical devices as well as their in-process intermediates and raw materials are microplate-based. They require tedious reconstitution and dilution steps for preparation of Control Standard Endotoxin (CSE) dilutions and Positive Product Controls (PPCs). These time-consuming manual handling steps can result in substantial variability and a significant rate of invalid results that demand repeat testing.

To address these issues, the GOPLATE™ was developed as a ready-to-use microplate embedding required CSE amounts in dried format, thus eliminating the need for the cnventional standard dilution. The GOPLATE thus loweors the risk for human error and cost-intensive test repitition. In this study, the new rFC test ENDOZYME II GO is compared with with kinetic-chromogenic LAL tests in terms of inclusivity, interferences, precision, exclusivity and limit of quantification.

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