ENDOZYME II GO recombinant Factor C assay: fast, easy andconsistent endotoxin testing

April 24, 2019

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 number of invalid results that demand repeat testing. To address these issues, as well as to reduce the time for microplate preparation, we have developed a ready-to-use microplate the GOPLATE embedding required CSE amounts in dried format. Thus, the conventional standard dilution has become completely obsolete; in turn, the GOPLATE significantly lowers the risk for human error and cost-intensive test repetition. The GOPLATE is included in a complete test kit, ENDOZYME II GO. The new microplate is the first of its kind, ready-to-use and enables high reduction in handling time as well as consistent standard curve and PPC accuracy.

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Sobi - Swedish Orphan Biovitrum AB (publ)

Sobi is an international specialty healthcare company dedicated to rare diseases. Our mission is to develop and deliver innovative therapies and services to improve the lives of patients.

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