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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Momenta Pharmaceuticals

Momenta is a biotechnology company with a product pipeline of both complex mixture generic and novel drugs. Our complex mixture generics and follow-on biologics effort is focused on building a thorough understanding of the structure-process-activity of complex mixture drugs to develop generic versions of marketed products. While we use a similar analytical and development approach across all of our product candidates, we tailor that approach for each specific product candidate.

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