| 摘要 |
<p>A process for preparing an adenovirus-containing preparation for in vivo somatic gene transfer to the myocardium or endothelium of large animals, comprising the steps of (i) generating adenovirus in a bioreactor under predetermined conditions for obtaining an adenovirus-containing medium; (ii) optionally separating of adenovirus from the adenovirus-containing medium of step (i) by filtration to obtain an adenovirus-containing filtrate; (iii) concentrating the adenovirus-containing medium of step (i) or the adenovirus-containing filtrate of step (ii) to obtain a adenovirus-containing concentrate; (iv) batch purification of the adenovirus-containing concentrate of step (iii) by a Fast Protein Liquid Chromatography (FPLC) in at least two steps at a pressure of less than 0.3 MPa and a volume of at least 200 ml to obtain an adenovirus-containing batch; (v) optionally concentrating the adenovirus-containing batch of step (iv) to obtain a concentrated adenovirus-containing batch; and (vi) optionally dialysis of the adenovirus-containing batch of step (iv) or the concentrated adenovirus-containing batch of step (v), to obtain an adenovirus-containing preparation.</p> |
