大型除菌过滤器在重组干扰素生产中的应用

The use of larger filter in production of recombinant interferon

为适应大规模生产的需要 ,用Millipore 2 93型滤器取代常用的赛氏滤器对重组干扰素α1b及γ进行除菌过滤 ,此种大型滤器不仅滤膜面积大 ,而且单位面积过滤量也有明显增加 ,因此 ,过滤速度显著加快 ,可适应大规模生产的应用。用此二种滤器作除菌过滤对干扰素活性无影响 ,过滤制品前用 2 %白蛋白预滤可减少滤膜吸附干扰素作用 ,Millipore和赛氏滤器除菌过滤后热原质均能达到肌肉注射标准 ,且大部分能达到静脉注射标准 ,有个别制品用赛氏滤器过滤后热原质达不到静脉注射标准者 ,用Millipore滤器复滤后 ,可以合格。上述结果表明用Milli pore2

Milliprore filter(Type 293)has been used to replace Seitz filter to filtrate recombinant interferon α 1b and γ in lager scale poduction. Millipore filter has larger filtration memberane area and bigger filtration volume than those of Seitz filter,so the filtration speed is obviously increased be suitable for large scale production.The test results inducate that there have no interferon of effects on the bioactivity of interferon by using above two types of filters.The adsorption of interferon by filter memberane can be reduced by prefiltration of 2% albumin before filtrating interferon.The preparation filtered by Millpore and Seitz filters all passed the pyrogen test for intramuscalar injection.Most of the preparation comply with the requirement of pyrogen for intravenous injection but a few of lots filtrated by Seitz filter fail to do so,those lost were re filtrated by Millipore filter and passed the pyrogen test.Above results indicated that Millipore(type 293)is suitable for large scale production of recombinant interferon α 1b and γ.