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CBC is currently developing several assay kits that can be used to measure gelsolin levels in patients. Several formats (standard laboratory kits and point-of-care kits) and several types of assays (ELISA assay, functional assay and Western blots) for this test are being explored.
SolinexTM (rhu-pGelsolin) is an investigation drug currently being manufactured for Critical Biologics Corporation by QSV. Manufacture of this biotechnology drug is performed under strict cGMP conditions. The protein is harvested from E. coli transfected with an expression plasmid containing the human cDNA coding for plasma gelsolin. The purification of rhu-pGelsolin consists of four chromatographic steps and a final diafiltration/concentration step using crossflow ultrafiltration. Proper folding of the molecule is completed during the processing. The drug is formulated as 10 mg/mL rhu-pGelsolin solution for IV infusion.
