| 摘要 |
<p>Preparation of an injectable formulation of interferon-beta (INF-beta ) involves precipitating purified IFN-beta , dissolving the precipitate INF-beta with guanidine hydrochloride followed by addition of a first buffer and removing residual guanidine hydrochloride by diafiltration or dialysis using second buffer. Preparation of an injectable formulation of interferon-beta (INF-beta ) involves preparing a first solution comprising IFN-beta , isolating a pool of purified IFN-beta from this solution, and precipitating the INF-beta from this pool using an alcohol to form a precipitate, dissolving the precipitate in guanidine hydrochloride (HCl) to form a second solution comprising resolubilized denatured INF-beta and guanidine HCl, diluting the second solution into a first buffer to obtain a third solution comprising resolubilized renatured IFN-beta and residual guanidine HCl, and removing the residual guanidine HCl from the third solution by diafiltration or dialysis into a second buffer. Independent claims are also included for: (1) a pharmaceutical composition (I) comprising substantially monomeric IFN-beta ; and (2) preparation of (I) comprising preparing a precipitate in guanidine hydrochloride (HCl) to obtain a first solution comprising resolubilized denatured IFN-beta ; and renaturing the IFN-beta by dilution of the first solution with a buffer solution.</p> |
