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English to Russian translations [PRO] Science - Biology (-tech,-chem,micro-) | | English term or phrase: solubility facilitating agent | | A stable lyophilized formulation of an anti-12u antibody or antibody/drug conjugate may be prepared by (a) dissolving an antibody/drug conjugate to a final concentration of 0.5 to 2 mg/ml in a solution comprising a cryoprotectant at a concentration of 1.5%-5% by weight, a polymeric bulking agent at a concentration of 0.5-1.5% by weight, electrolytes at a concentration 0.01 M to 0.1 M, a solubility facilitating agent at a concentration of 0.005% to 0.05% by weight, buffering agent at a concentration of 5-50 mM such that the final pH of the solution is 7.8-8.2, and water; (b) dispensing the above solution into vials at a temperature of +5C to +10C; (c) freezing the solution at a freezing temperature of -35C to -50C; (d) subjecting the frozen solution to an initial freeze drying step at a primary drying pressure of 20 to 80 microns at a shelf temperature at -10C to -40C for 24 to 78 hours; and (e) subjecting the freeze-dried product of step (d) to a secondary drying step at a drying pressure of 20 to 80 microns at a shelf temperature of +10C to + 35C for 15 to 30 hours |
| katerina24KudoZ activityQuestions: 287 (none open) ( 1 closed without grading) Answers: 22
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 Vitaly Ashkinazi Russian Federation Local time: 16:30
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3 mins confidence:  peer agreement (net): +5 | |