bingduzaitijiyinliaofashiyongxiushidebingduzuoweiyaowudisongzaiti,kejiangtedingde dna xuliebianmajiyin、diaojie rnahuoqitazhiliaodiwudisongzhixibao。muqianchangyongdebingduzaitibaokuo:xianxiangguanbingduzaiti(adeno-associated-virus vectors)、manbingduzaiti(lentivirus vectors)、nizhuanlubingdu(retrovirus)、hexianbingduzaiti(adenovirus vectors)deng。
zuoweibingduzaitiyanfagonghuoshang,anbiqiyijingjianlilewanshandebingduzaitikaifapingtaihefuheguoneiwaifaguihejianguanyaoqiudelinghuoshengchanxian,baokuocongbingduzaitisheji、xibaoxikaifashengchan、daogongyiyouhuafangda、bingduzaitiguimohuashengchanhezhiliangjiancefuwu。womenzhiliyuweikehutigonggaozhiliang、juyouchengbenxiaoyihejingquedezhuxibaokuhegmp jibiebingduzaiti,jiasuyaowuyanfahexiangmushenbaojincheng。
服务范围
yanjiujibiebingdu:shiyongyujichuyanjiuheyaowufaxianyanjiujieduan,tongguoyangedezhikongpingtaiquebaohuodegaozhiliangbingdu,yiyingyongyuxiayoubutongleibiedeyanjiu。
gmp-likejibiebingdu:shiyongyulinchuangqianyanjiujieduan,ruceshiyaowuzaidongwutineidaixiejianquanxingdeyanjiu。gmp-likexiangdangyuxiaoguimogmpshengchan,jibenanzhaogmpzhinanguanjianyaoqiujinxingshengchan,danshifeiyonggengdi,zhouqigengduan。
gmpjibiebingdu:yangeanzhaogmpguifanjinxingshengchan,juyouwanshandezhiliangfenxiyukongzhipingtai。
服务流程
服务特色
manzuduozhongbingduzaitichanpinxuqiu:chengshudeaav、xianbingdu、manbingduhenizhuanlubingduzaitishengchanpingtai;
gaozhiliangxibaojiankupingtai:zhichitiebigongyihexuanfugongyiduozhongyoushixibaozhu,tigongyuanshixibaoku(pcb)、zhuxibaoku(mcb)hegongzuoxibaoku(wcb)goujian、xibaowendingxingyanjiuyijichucunfuwu;
manzubutongkehuchannengxuqiu:shengchanguimoconggaotongliang 20 ml lixinguandao 200 l shengwufanyingqi。shebeicongweixingshengwufanyingqi、yaoping、gezhongjiaobanguanshengwufanyingqidaogudingchuangshengwufanyingqi,zhichigaomiduxibaopeiyang。
kekuozhanqiewenjiandebingduzaitichunhuafuwu:shidangguimodexiayoushebeiyubutongdeshangyougongyixingshiheguimoxiangpipei,yongyuchengqing、nongsuo、cengxiheguolv。
yangegmpguifan:wanshandezhiliangfenxiyukongzhipingtai;
交付周期短;
tigonggetihuadingzhifuwu;
服务内容
不同级别病毒载体生产服务内容
服务 | 科研级别 | GMP-Like级别 | GMP级别 |
可溯源的悬浮/贴壁细胞库 | - | + | + |
病毒上游生产工艺优化 | - | + | + |
转染条件的优化 | - | + | + |
病毒下游纯化工艺的优化 | - | + | + |
工艺确认批次生产 | - | 可定制 | + |
病毒的生产与鉴定 | + | + | + |
批生产记录 | - | 可定制 | + |
批检验记录 | - | 可定制 | + |
产品检验报告 | + | 可定制 | + |
相关溯源性材料 | - | 可定制 | + |
生产分析开发服务
生产阶段 | 目的 | 可用服务 |
上游 | 优化放大和生产参数,包括培养和转染条件 |
|
下游 | 优化产品回收、纯化和配制程序 |
|
QC | 确保最终 GMP 药品的安全性、效力、纯度和特性 |
|