| 主权项 |
1. A method of manufacturing a LMWH (e.g., an M402) pharmaceutical composition, the method comprising:
producing a batch of a LMWH preparation (e.g., a drug substance); determining for a sample of the batch whether the activity of the LMWH preparation is within a predetermined range by: exposing the sample to an assay comprising a population of cells that respond to a stimulant (e.g., a protein, e.g., a cytokine, e.g., SDF1α) in the absence of the LMWH within a predetermined first range; and determining, in the assay, whether the cellular response in the presence of the LMWH is within a predetermined second range (e.g., which is lower than said first range); and formulating the batch of LMWH (e.g., for medical use), to thereby manufacture a LMWH (e.g., an M402) pharmaceutical composition (e.g., a drug product). |
