药明生物全球很大使用一次性反应器的生物制药cGMP生产基地全面投产

2017-12-07 药明康德 药明康德

/* Style Definitions */ span.prnews_span { font-size:8pt; font-family:"Arial"; color:black; } a.prnews_a { color:blue; } li.prnews_li

-药明生物扩建的cGMP生产基地总产能达30,000升,将有力提升中国生物制药产业的国际地位

12月6日,全球领先的生物制药技术平台公司药明生物(WuXi Biologics, 2269.HK)宣布在无锡扩建的全球最大使用一次性反应器的生物制药cGMP生产基地全面投产,总产能达30,000升。这是药明生物乃至中国生物制药行业发展的一个重要里程碑。

2015年4月,药明生物宣布投资1.5亿美元在无锡扩建全球领先的生物制药生产基地,次年9月该基地2个1,000升灌流生产反应器的一期工程建成投入cGMP生产,成为亚洲最大使用一次性反应器的生物制药灌流生产车间;短短15个月后,新安装的14个2,000升流加细胞培养反应器已用于cGMP生产。

随着建筑面积约4.6万平方米的新生产基地全面投产,药明生物cGMP生产能力将增加至之前水平的五倍,这将为全球合作伙伴即将上市生物药的商业化生产提供有力支持,加速生物新药从创新概念到商业化生产的整个进程,进一步巩固药明生物在生物制药委托生产领域中国第一、全球领先的地位,提升中国生物制药产业的国际地位。同时该基地也是已投产的中国最大的生物药生产基地之一,为我国药品上市许可持有人制度(MAH)政策的实施提供有效的支持,有助于进一步提高我国生物医药规模化生产的能力。

新基地的投产是对药明生物已有的强大生物制药生产能力的有力补充。早在2012年,公司已在无锡建成中国首个同时符合美国、欧盟以及中国cGMP标准、世界领先的生物制药生产厂房。该生产基地自投产以来不断提高产能至6,000升,以满足全球合作伙伴的临床样品生产需求,并于2014年获得国际制药工程师协会(ISPE)颁发的“年度特别奖”,使药明生物成为中国首家获得国际ISPE奖项认可的企业。今年8月,美国FDA在该基地完成了药明生物合作伙伴中裕新药抗艾滋病生物新药ibalizumab的批准前检查(Pre-License Inspection, PLI),这也是中国生物制药企业首次接受美国FDA类似检查。

“从想到使用一次性反应器进行大规模生产这个先进理念到建成全球最大使用一次性反应器的生产基地,我们仅仅用了两年多时间。这样先进的厂房设计投资低、建设周期短,如今已经被国内外多家公司相继引用,成为生物药厂房设计的新潮流。”药明生物首席执行官陈智胜博士表示,“新基地的全面投产将为更多国、内外合作伙伴提供更大产能、更高效率和更加灵活的生产服务。”

“我非常高兴药明生物新基地正式投入运营。”药明生物董事长李革博士表示,我们将继续提升药明生物加快和转变全球生物制药发现、开发及生产的全方位一体化服务能力,为合作伙伴加快生物新药研发速度、降低研发生产成本,造福全球病患。”

关于药明生物

药明生物作为一家香港上市公司,是全球领先的开放式、一体化生物制药能力和技术平台。公司为全球生物制药公司和生物技术公司提供全方位的端到端研发服务,帮助任何人、任何公司发现、开发及生产生物药,实现从概念到商业化生产的全过程,加速全球生物药研发进程,降低研发成本,造福病患。如需更多信息,请访问:www.wuxibiologics.com.cn。

版权声明:
本网站所有内容来源注明为“梅斯医学”或“MedSci原创”的文字、图片和音视频资料,版权均属于梅斯医学所有。非经授权,任何媒体、网站或个人不得转载,授权转载时须注明来源为“梅斯医学”。其它来源的文章系转载文章,或“梅斯号”自媒体发布的文章,仅系出于传递更多信息之目的,本站仅负责审核内容合规,其内容不代表本站立场,本站不负责内容的准确性和版权。如果存在侵权、或不希望被转载的媒体或个人可与我们联系,我们将立即进行删除处理。
在此留言
评论区 (5)
#插入话题
  1. [GetPortalCommentsPageByObjectIdResponse(id=2050101, encodeId=04932050101de, content=<a href='/topic/show?id=4691454e37' target=_blank style='color:#2F92EE;'>#CGM#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=58, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4547, encryptionId=4691454e37, topicName=CGM)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=5d70341, createdName=zhishijing, createdTime=Tue Jan 16 20:27:00 CST 2018, time=2018-01-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1376692, encodeId=4dbc13e669278, content=<a href='/topic/show?id=30488132aa' target=_blank style='color:#2F92EE;'>#GMP#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=46, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8132, encryptionId=30488132aa, topicName=GMP)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8c6f389, createdName=hxq78316, createdTime=Sat Dec 09 01:27:00 CST 2017, time=2017-12-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1387648, encodeId=6381138e64828, content=<a href='/topic/show?id=75146922836' target=_blank style='color:#2F92EE;'>#生物制药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=48, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=69228, encryptionId=75146922836, topicName=生物制药)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTIibticIBly5jCSic5ZElW4He3rO4DMpUHUFaFX57OicNMnzckWaicBNeStwugWHFCuOdicoakApM4HGmtw/132, createdBy=f8672500006, createdName=ms6390871039024434, createdTime=Sat Dec 09 01:27:00 CST 2017, time=2017-12-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1517749, encodeId=02c2151e74964, content=<a href='/topic/show?id=44156886664' target=_blank style='color:#2F92EE;'>#生产#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=68866, encryptionId=44156886664, topicName=生产)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=37a111112788, createdName=ms1343860338762272, createdTime=Sat Dec 09 01:27:00 CST 2017, time=2017-12-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1581589, encodeId=d9fb158158939, content=<a href='/topic/show?id=22a08e6050d' target=_blank style='color:#2F92EE;'>#药明生物#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=87605, encryptionId=22a08e6050d, topicName=药明生物)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=e3e016837754, createdName=ms7421025882867189, createdTime=Sat Dec 09 01:27:00 CST 2017, time=2017-12-09, status=1, ipAttribution=)]
    2018-01-16 zhishijing
  2. [GetPortalCommentsPageByObjectIdResponse(id=2050101, encodeId=04932050101de, content=<a href='/topic/show?id=4691454e37' target=_blank style='color:#2F92EE;'>#CGM#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=58, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4547, encryptionId=4691454e37, topicName=CGM)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=5d70341, createdName=zhishijing, createdTime=Tue Jan 16 20:27:00 CST 2018, time=2018-01-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1376692, encodeId=4dbc13e669278, content=<a href='/topic/show?id=30488132aa' target=_blank style='color:#2F92EE;'>#GMP#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=46, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8132, encryptionId=30488132aa, topicName=GMP)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8c6f389, createdName=hxq78316, createdTime=Sat Dec 09 01:27:00 CST 2017, time=2017-12-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1387648, encodeId=6381138e64828, content=<a href='/topic/show?id=75146922836' target=_blank style='color:#2F92EE;'>#生物制药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=48, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=69228, encryptionId=75146922836, topicName=生物制药)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTIibticIBly5jCSic5ZElW4He3rO4DMpUHUFaFX57OicNMnzckWaicBNeStwugWHFCuOdicoakApM4HGmtw/132, createdBy=f8672500006, createdName=ms6390871039024434, createdTime=Sat Dec 09 01:27:00 CST 2017, time=2017-12-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1517749, encodeId=02c2151e74964, content=<a href='/topic/show?id=44156886664' target=_blank style='color:#2F92EE;'>#生产#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=68866, encryptionId=44156886664, topicName=生产)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=37a111112788, createdName=ms1343860338762272, createdTime=Sat Dec 09 01:27:00 CST 2017, time=2017-12-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1581589, encodeId=d9fb158158939, content=<a href='/topic/show?id=22a08e6050d' target=_blank style='color:#2F92EE;'>#药明生物#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=87605, encryptionId=22a08e6050d, topicName=药明生物)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=e3e016837754, createdName=ms7421025882867189, createdTime=Sat Dec 09 01:27:00 CST 2017, time=2017-12-09, status=1, ipAttribution=)]
    2017-12-09 hxq78316
  3. [GetPortalCommentsPageByObjectIdResponse(id=2050101, encodeId=04932050101de, content=<a href='/topic/show?id=4691454e37' target=_blank style='color:#2F92EE;'>#CGM#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=58, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4547, encryptionId=4691454e37, topicName=CGM)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=5d70341, createdName=zhishijing, createdTime=Tue Jan 16 20:27:00 CST 2018, time=2018-01-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1376692, encodeId=4dbc13e669278, content=<a href='/topic/show?id=30488132aa' target=_blank style='color:#2F92EE;'>#GMP#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=46, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8132, encryptionId=30488132aa, topicName=GMP)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8c6f389, createdName=hxq78316, createdTime=Sat Dec 09 01:27:00 CST 2017, time=2017-12-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1387648, encodeId=6381138e64828, content=<a href='/topic/show?id=75146922836' target=_blank style='color:#2F92EE;'>#生物制药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=48, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=69228, encryptionId=75146922836, topicName=生物制药)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTIibticIBly5jCSic5ZElW4He3rO4DMpUHUFaFX57OicNMnzckWaicBNeStwugWHFCuOdicoakApM4HGmtw/132, createdBy=f8672500006, createdName=ms6390871039024434, createdTime=Sat Dec 09 01:27:00 CST 2017, time=2017-12-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1517749, encodeId=02c2151e74964, content=<a href='/topic/show?id=44156886664' target=_blank style='color:#2F92EE;'>#生产#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=68866, encryptionId=44156886664, topicName=生产)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=37a111112788, createdName=ms1343860338762272, createdTime=Sat Dec 09 01:27:00 CST 2017, time=2017-12-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1581589, encodeId=d9fb158158939, content=<a href='/topic/show?id=22a08e6050d' target=_blank style='color:#2F92EE;'>#药明生物#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=87605, encryptionId=22a08e6050d, topicName=药明生物)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=e3e016837754, createdName=ms7421025882867189, createdTime=Sat Dec 09 01:27:00 CST 2017, time=2017-12-09, status=1, ipAttribution=)]
  4. [GetPortalCommentsPageByObjectIdResponse(id=2050101, encodeId=04932050101de, content=<a href='/topic/show?id=4691454e37' target=_blank style='color:#2F92EE;'>#CGM#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=58, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4547, encryptionId=4691454e37, topicName=CGM)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=5d70341, createdName=zhishijing, createdTime=Tue Jan 16 20:27:00 CST 2018, time=2018-01-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1376692, encodeId=4dbc13e669278, content=<a href='/topic/show?id=30488132aa' target=_blank style='color:#2F92EE;'>#GMP#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=46, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8132, encryptionId=30488132aa, topicName=GMP)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8c6f389, createdName=hxq78316, createdTime=Sat Dec 09 01:27:00 CST 2017, time=2017-12-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1387648, encodeId=6381138e64828, content=<a href='/topic/show?id=75146922836' target=_blank style='color:#2F92EE;'>#生物制药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=48, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=69228, encryptionId=75146922836, topicName=生物制药)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTIibticIBly5jCSic5ZElW4He3rO4DMpUHUFaFX57OicNMnzckWaicBNeStwugWHFCuOdicoakApM4HGmtw/132, createdBy=f8672500006, createdName=ms6390871039024434, createdTime=Sat Dec 09 01:27:00 CST 2017, time=2017-12-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1517749, encodeId=02c2151e74964, content=<a href='/topic/show?id=44156886664' target=_blank style='color:#2F92EE;'>#生产#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=68866, encryptionId=44156886664, topicName=生产)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=37a111112788, createdName=ms1343860338762272, createdTime=Sat Dec 09 01:27:00 CST 2017, time=2017-12-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1581589, encodeId=d9fb158158939, content=<a href='/topic/show?id=22a08e6050d' target=_blank style='color:#2F92EE;'>#药明生物#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=87605, encryptionId=22a08e6050d, topicName=药明生物)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=e3e016837754, createdName=ms7421025882867189, createdTime=Sat Dec 09 01:27:00 CST 2017, time=2017-12-09, status=1, ipAttribution=)]
  5. [GetPortalCommentsPageByObjectIdResponse(id=2050101, encodeId=04932050101de, content=<a href='/topic/show?id=4691454e37' target=_blank style='color:#2F92EE;'>#CGM#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=58, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4547, encryptionId=4691454e37, topicName=CGM)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=5d70341, createdName=zhishijing, createdTime=Tue Jan 16 20:27:00 CST 2018, time=2018-01-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1376692, encodeId=4dbc13e669278, content=<a href='/topic/show?id=30488132aa' target=_blank style='color:#2F92EE;'>#GMP#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=46, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8132, encryptionId=30488132aa, topicName=GMP)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8c6f389, createdName=hxq78316, createdTime=Sat Dec 09 01:27:00 CST 2017, time=2017-12-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1387648, encodeId=6381138e64828, content=<a href='/topic/show?id=75146922836' target=_blank style='color:#2F92EE;'>#生物制药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=48, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=69228, encryptionId=75146922836, topicName=生物制药)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTIibticIBly5jCSic5ZElW4He3rO4DMpUHUFaFX57OicNMnzckWaicBNeStwugWHFCuOdicoakApM4HGmtw/132, createdBy=f8672500006, createdName=ms6390871039024434, createdTime=Sat Dec 09 01:27:00 CST 2017, time=2017-12-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1517749, encodeId=02c2151e74964, content=<a href='/topic/show?id=44156886664' target=_blank style='color:#2F92EE;'>#生产#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=68866, encryptionId=44156886664, topicName=生产)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=37a111112788, createdName=ms1343860338762272, createdTime=Sat Dec 09 01:27:00 CST 2017, time=2017-12-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1581589, encodeId=d9fb158158939, content=<a href='/topic/show?id=22a08e6050d' target=_blank style='color:#2F92EE;'>#药明生物#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=87605, encryptionId=22a08e6050d, topicName=药明生物)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=e3e016837754, createdName=ms7421025882867189, createdTime=Sat Dec 09 01:27:00 CST 2017, time=2017-12-09, status=1, ipAttribution=)]

相关资讯

GE医疗新一代便携式心脏超声诊断仪VividTM iq上市

/* Style Definitions */ span.prnews_span { font-size:8pt; font-family:"Arial"; color:black; } a.prnews_a { color:blue; } li.prnews_li

拜耳大力投入差异化药物研发产品线

/* Style Definitions */ span.prnews_span { font-size:8pt; font-family:"Arial"; color:black; } a.prnews_a { color:blue; } li.prnews_

诺华连续三年蝉联“中国杰出雇主”认证

/* Style Definitions */ span.prnews_span { font-size:8pt; font-family:"Arial"; color:black; } a.prnews_a { color:blue; } li.prnews_

强生创新与上海市政府、浦东新区政府和张江集团共建“上海JLABS”

/* Style Definitions */ span.prnews_span { font-size:8pt; font-family:"Arial"; color:black; } a.prnews_a { color:blue; } li.prnews_li