Although the FDA has not published limits for acceptable levels of leached Protein A, manufacturers are required to characterize and quantify the levels of Protein A contaminants in the final therapeutic formulation.
■Reproducibility
Repligen's Protein A ELISA kits demonstrate high inter- and intra-kit consistency.
Sample preparation protocol
Repligen has designed three sample preparation protocols that maximize ease of use, speed, and limits of detection and quantification.
■Dilute and Go™
・No buffer exchange step required, maximizing ease of use and assay run time
-Samples can be diluted directly into the assay
■Boil and Boost™
Increase sample input concentration and lower limit of quantification
■Original protocol
・Ideal for traditional methods
・Buffer exchange step required
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