杭州皓阳生物技术有限公司

服务内容

皓阳生物专注于为客户提供抗体、融合蛋白、ADC类产品从早期成药性评估、IND药学研究到商业化生产的一站式研发、生产服务。

早期发现

稳定细胞株构建

工艺开发

临床样品生产

商业化生产

基因治疗

早期发现

为业内客户提供高质量的抗体和重组蛋白定制生产服务，助力蛋白质药物早期研发工作。
了解更多>>
稳定细胞株构建

皓阳生物基于可商业化授权的CHO-K1细胞株，结合自有的质粒系统以及细胞株筛选方案，建立HaoYue稳定细胞株平台。2022年，基于HaoYue的基础上进一步打造Fut8敲除的ADCC加强型稳定细胞株构建平台，为客户提供更多元的选择与服务。
工艺开发

基于QbD的工艺开发能力，我们可以加速您的药物开发过程。
临床样品生产

· 5000㎡符合FDA，EMA，NMPA，cGMP要求的原液和制剂GMP生产线，为客户提供大分子药物毒理样品生产、新药临床申请样品生产、临床研究样品生产服务。
· 500㎡符合FDA，EMA，NMPA，cGMP要求的独立ADC原液和制剂GMP生产线。
商业化生产

抗体生产线：6*2,000 L；
ADC 生产线：1* 500 L；
抗体西林瓶冻干生产线：50,000 支/批次；
抗体预充针生产线：100,000 支/批次；
ADC西林瓶冻干生产线：20,000 支/批次。
基因治疗

提供全流程AAV/ mRNA CRO服务，探索一切技术的可能。

< >

我们的优势

01

纯粹的生物药CDMO服务

一站式纯粹的生物药CDMO服务商，在技术、设施和流程方面专注于提供高质量研发和定制化的服务。有着广泛的的经验累积和专业知识，适应各种不同项目需求。专注于提供无竞争冲突的服务，可以和客户建立更强的信任和合作关系。
02

系统性成药性评估

国内最早开展系统性成药性评估的公司之一，从CMC需求立足展开成药性评估。系统性评估能够为药物开发团队提供全面的数据和见解，从而指导候选分子的确认和引导药物的工艺、质量控制和稳定性设计。降低后期开发的风险，助力药物开发的成功。
03

对称结构单/双抗5g/L保底

团队有超过15年的稳定细胞株开发经验，创新方法和优秀的技术开发确保了稳定细胞株的高产量和稳定性。以高效、高通量的自动化稳定细胞株构建平台为支持，能够在常规的14天Fed-batch工艺下，交付出不低于5g/L产量的对称结构单/双抗体稳定细胞株。并具备大量的复杂分子，如非对称性结构双/三抗，融合蛋白，酶等项目的成熟开发经验。
04

最快1周完成偶联制备交付

每年成功交付超过200个以上的样品偶联制备，在ADC领域拥有深厚的项目经验。熟悉各种偶联技术和毒素分子，能够根据不同药物特性和目标，选择并运用最适合的技术策略。具备完善的ADC表征平台，全面了解和评估ADC的特性，还能为客户提供深入的分析和解读。
05

卓越和高效率的CMC交付能力

拥有完备的抗体原液和成品GMP生产线，以及专业的ADC原液GMP生产线。够在短短7个月至8个月的时间内，完成从DNA到毒理批抗体和ADC样品的制备，为客户提供迅速交付的解决方案。卓越速度和高效率能够帮助客户迅速启动IND阶段，从而在药物开发的关键阶段取得快速的优势。
06

丰富的项目管理经验

项目经验丰富的管理团队在药物开发和生产方面拥有广泛的专业知识，够高效地规划项目流程，在执行各个阶段都能够与客户保持紧密的合作，及时传递项目进展、风险和决策，从而保障项目的顺利推进。其严格的质量管理流程确保了每个项目在所有阶段都符合国际标准和监管要求。

< >

01

纯粹的生物药CDMO服务

02

系统性
成药性评估

03

对称结构单/双
抗5g/L保底

04

最快1周完成
偶联制备交付

05

卓越和高效率的
CMC交付能力

06

丰富的
项目管理经验

关于皓阳

皓阳生物创立于2015年，从最初的稳定细胞株构建服务起步，业务逐步拓展至早研、CMC、GMP生产等领域。经过多年的耕耘，我们以卓越的服务和口碑，吸引了众多客户的青睐。如今，我们拥有一支充满活力的团队以及位于上海和杭州的3个先进生产基地，总面积超过50000㎡。我们立志成为中国乃至全球领先的CDMO服务提供商，为客户提供最优质的解决方案，助力他们在药物研发领域取得辉煌成就。

160 ₊

CLD交付项目

1300 ₊

ADC交付项目

35_个

IND阶段项目

最新资讯

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[ SQL ] SELECT * FROM `cmf_portal_category` WHERE `parent_id` = 5 AND `status` = 1 ORDER BY `list_order` ASC [ RunTime:0.012154s ]
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[ SQL ] SELECT * FROM `cmf_portal_category` WHERE `parent_id` = 25 AND `status` = 1 ORDER BY `list_order` ASC [ RunTime:0.012214s ]
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[ SQL ] SELECT * FROM `cmf_portal_category` WHERE `parent_id` = 59 AND `status` = 1 ORDER BY `list_order` ASC [ RunTime:0.012155s ]
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[ SQL ] SELECT * FROM `cmf_portal_category` WHERE `parent_id` = 21 AND `status` = 1 ORDER BY `list_order` ASC [ RunTime:0.012149s ]
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[ SQL ] SELECT * FROM `cmf_portal_category` WHERE `parent_id` = 26 AND `status` = 1 ORDER BY `list_order` ASC [ RunTime:0.012218s ]
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[ SQL ] SELECT * FROM `cmf_portal_category` WHERE `parent_id` = 27 AND `status` = 1 ORDER BY `list_order` ASC [ RunTime:0.012120s ]
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[ SQL ] SELECT * FROM `cmf_portal_category` WHERE `parent_id` = 60 AND `status` = 1 ORDER BY `list_order` ASC [ RunTime:0.012215s ]
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[ SQL ] SELECT * FROM `cmf_portal_category` WHERE `parent_id` = 61 AND `status` = 1 ORDER BY `list_order` ASC [ RunTime:0.012131s ]
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[ SQL ] SELECT * FROM `cmf_portal_category` WHERE `parent_id` = 62 AND `status` = 1 ORDER BY `list_order` ASC [ RunTime:0.012164s ]
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[ SQL ] SELECT * FROM `cmf_portal_category` WHERE `parent_id` = 64 AND `status` = 1 ORDER BY `list_order` ASC [ RunTime:0.012249s ]
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[ SQL ] SELECT * FROM `cmf_portal_category` WHERE `parent_id` = 65 AND `status` = 1 ORDER BY `list_order` ASC [ RunTime:0.012259s ]
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[ SQL ] SELECT * FROM `cmf_portal_category` WHERE `parent_id` = 66 AND `status` = 1 ORDER BY `list_order` ASC [ RunTime:0.012183s ]
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[ SQL ] SHOW COLUMNS FROM `cmf_theme_file` [ RunTime:0.012659s ]
[ SQL ] SELECT * FROM `cmf_theme_file` WHERE `theme` = 'simpleboot3' AND `file` = 'portal/aaa' LIMIT 1 [ RunTime:0.012109s ]
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[ SQL ] UPDATE `cmf_theme_file` SET `theme`='simpleboot3',`action`='portal/List/index',`file`='portal/aaa',`name`='默认列表模板',`more`='[]',`config_more`='[]',`description`='aaa',`is_public`=0,`list_order`=10 WHERE `theme` = 'simpleboot3' AND `file` = 'portal/aaa' [ RunTime:0.015242s ]
[ SQL ] SELECT * FROM `cmf_theme_file` WHERE `theme` = 'simpleboot3' AND `file` = 'portal/aaa_detail' LIMIT 1 [ RunTime:0.012175s ]
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[ SQL ] UPDATE `cmf_theme_file` SET `theme`='simpleboot3',`action`='portal/Article/index',`file`='portal/aaa_detail',`name`='默认详情模板',`more`='[]',`config_more`='[]',`description`='aaa_detail',`is_public`=0,`list_order`=10 WHERE `theme` = 'simpleboot3' AND `file` = 'portal/aaa_detail' [ RunTime:0.014253s ]
[ SQL ] SELECT * FROM `cmf_theme_file` WHERE `theme` = 'simpleboot3' [ RunTime:0.012274s ]
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[ SQL ] SHOW COLUMNS FROM `cmf_theme` [ RunTime:0.012847s ]
[ SQL ] UPDATE `cmf_theme` SET `name`='simpleboot3',`version`='1.0.2',`demo_url`='http://demo.thinkcmf.com',`author`='ThinkCMF',`lang`='zh-cn',`author_url`='http://www.thinkcmf.com',`keywords`='ThinkCMF模板',`description`='ThinkCMF默认模板' WHERE `theme` = 'simpleboot3' [ RunTime:0.014501s ]
[ SQL ] SELECT `more` FROM `cmf_theme_file` WHERE `theme` = 'simpleboot3' AND ( `is_public` = 1 OR `file` = 'portal/index' ) [ RunTime:0.012107s ]
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[ SQL ] SHOW COLUMNS FROM `cmf_slide` [ RunTime:0.012678s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `cmf_slide` WHERE `id` = 1 AND `status` = 1 AND `delete_time` = 0 LIMIT 1 [ RunTime:0.012237s ]
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[ SQL ] SHOW COLUMNS FROM `cmf_slide_item` [ RunTime:0.012711s ]
[ SQL ] SELECT * FROM `cmf_slide_item` WHERE `status` = 1 AND `slide_id` = 1 ORDER BY `list_order` ASC [ RunTime:0.012224s ]
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[ SQL ] SHOW COLUMNS FROM `cmf_option` [ RunTime:0.013636s ]
[ SQL ] SELECT `option_value` FROM `cmf_option` WHERE `option_name` = 'storage' LIMIT 1 [ RunTime:0.012181s ]
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[ SQL ] SHOW COLUMNS FROM `cmf_portal_post` [ RunTime:0.012982s ]
[ SQL ] SELECT post.*,min(category_post.category_id) as category_id FROM `cmf_portal_post` `post` INNER JOIN `cmf_portal_category_post` `category_post` ON `post`.`id`=`category_post`.`post_id` WHERE `post`.`post_status` = 1 AND `post`.`post_type` = 1 AND `post`.`delete_time` = 0 AND ( `category_post`.`category_id` = '22' ) AND ( `post`.`published_time` > '0' and `post`.`published_time` < 1752016489 ) GROUP BY `post`.`id` ORDER BY `post`.`post_orders` DESC LIMIT 1 [ RunTime:0.013391s ]
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[ SQL ] SELECT post.*,min(category_post.category_id) as category_id FROM `cmf_portal_post` `post` INNER JOIN `cmf_portal_category_post` `category_post` ON `post`.`id`=`category_post`.`post_id` WHERE `post`.`post_status` = 1 AND `post`.`post_type` = 1 AND `post`.`delete_time` = 0 AND ( `category_post`.`category_id` = '23' ) AND ( `post`.`published_time` > '0' and `post`.`published_time` < 1752016489 ) GROUP BY `post`.`id` ORDER BY `post`.`post_orders` DESC LIMIT 10 [ RunTime:0.031545s ]
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