华人抗体协会Industrial Frontier Webinar第十八讲：双抗药物开发的可商业化战略，从概念设计服务于最终生产

为了促进华人抗体协会会员间的交流与合作，华人抗体协会特邀华人抗体协会企业会员对该企业最新的技术平台进行分享，隆重推出 Industrial Frontier Webinar Series。特别感谢华人抗体协会企业会员皓阳生物对本次讲座的支持！

双特异性抗体（BsAbs）可以识别不同的抗原或者同一抗原的不同表位，具有不同的分子形式及作用机制。作为一种创新生物疗法，近年来在全球药物研发领域正迅速崛起。截至目前，全球已有 17 款双抗获批上市，200多款双特异性抗体在临床试验阶段，特别是在癌症治疗中表现尤为突出，涵盖如非小细胞肺癌、淋巴瘤、肝癌等多种癌症类型。这种持续扩展的研发管线和不断增长的临床成功，使得双特异性抗体在制药公司和生物科技公司中成为竞相开发的重要品类。

本次讲座有幸邀请到皓阳生物子公司李浩冬副总经理，李老师将以“双抗药物开发的可商业化战略，从概念设计服务于最终生产”为主题，介绍如何从概念设计到工艺开发均服务于最终生产。

本期主讲人李浩冬女士

 

毕业于华东理工大学生物工程专业，硕士研究生，曾在北京大学进行过学习和深造。先后就职于复星集团，药明康德，联合赛尔，默克化工等10家国内外企业，7年以上全球500强外资公司带领亚太团队经验，负责亚太区实验室的日常运营和管理。具有26年生物大分子CMC经验，尤其擅长蛋白纯化，从事过大肠杆菌、酵母、CHO细胞表达的融合蛋白、多肽、激素、酶类、抗体、双抗等类型分子的工艺开发，技术转移和生产放大，完成过生物大分子工艺表征与验证。参与过的项目至今已有7个在市场上流通，超过10个分子在临床阶段。

She is graduated from East China University of Science and Technology with a major in Bioengineering, Master's degree. She has studied and furthered her education at Peking University. She has worked for 10 domestic and foreign companies including Fosun Group, WuXi AppTec, United Cell, and Merck Chemical, with over 7 years of experience leading Asia-Pacific teams in Fortune 500 multinational companies. She is responsible for the daily operation and management of laboratories in the Asia-Pacific region. She has 26 years of experience in biopolymer CMC, specializing in protein purification. She has been involved in the process development, technology transfer, and production scale-up of fusion proteins, peptides, hormones, enzymes, antibodies, bispecific antibodies, and other types of molecules expressed in Escherichia coli, yeast, and CHO cells. She has completed process characterization and process validation for biomacromolecules products. She has participated in at least 7 projects currently on the market, with over 10 molecules in clinical stages.

讲座题目： 双抗药物开发的可商业化战略，从概念设计服务于最终生产

摘要：本次研讨会将以终为始的思路，深入探讨双抗药物的开发策略，重点关注如何在商业化生产中取得成功。我们将详细分析双抗分子的评估标准，并结合实际案例探讨工艺开发过程中需要考虑的关键因素，如工艺的可放大性、生产成本的有效控制以及如何在研发初期就奠定成功的基础。通过这些内容，我们希望为参与者提供全面的策略性指导，帮助他们实现从研发到大规模生产的平稳过渡。

Webinar Title: Commercial Strategies for Developing Bispecific Antibodies: From Concept to Production

Abstract:  This webinar will adopt an end-to-beginning approach, thoroughly exploring the strategies for developing bispecific antibodies with a focus on achieving commercial production success. We will analyze the evaluation criteria for bispecific molecules in detail and discuss key factors to consider during process development, such as scalability, effective cost control, and laying a solid foundation for success in the early stages of R&D. Through these insights, we aim to provide participants with comprehensive strategic guidance to ensure a smooth transition from research to large-scale production.

讲座时间为：美国东部时间2024年11月02日（周六）晚上9点-10点，北京时间2024年11月03日（周日）上午9点-10点。

请点击二维码注册讲座 

本期赞助商介绍

杭州皓阳生物技术有限公司成立于2015年，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。服务内容包括：早期成药性评估，稳定细胞株构建，抗体及ADC工艺开发，中试生产和IND申报，临床样品生产，工艺表征、验证和商业化生产，培养基开发定制开发等。

公司在上海和杭州两地设有研发、生产基地，上海研发中心依托多种分析手段和瞬时表达平台为客户提供从人源化设计，活性分析到成药性分析多维度的分子设计和评估；杭州研发中心拥有自主开发可授权的高表达稳定细胞株构建平台（皓越）和工艺开发平台；中试生产基地建有完善的250L/500L规模抗体原液和成品GMP生产线和100L规模ADC原液GMP生产线，分别能够在7个月和8个月提供从DNA到毒理批抗体和ADC样品交付。同时公司还在建6*2000L规模抗体商业化生产线和500L规模ADC商业化生产线，将于2024年陆续投入使用。

皓阳生物致力于通过帮助新药研发来推动生物医药领域的进步，实现创新为民、科技惠民的目标。公司立足中国，实践 “聆听 深耕 开拓 共赢”的企业精神，努力打造一个行业地位突出，管理先进的现代化企业。更多详情请访问公司官网：www.hs-biopharm.com

Hangzhou Healsun Biopharm Co.,Ltd. started its journey in 2015 by providing stable cell line development services and has gradually expanded its scope of services to one-stop R&D and production solution for antibodies, fusion proteins, and ADC products from early druggability evaluation, stable cell line development, process development, pilot production, IND application, PC/PV, commercial production, to media development and customization.

The company has R&D and production facilities in both Shanghai and Hangzhou. The Shanghai R&D Center relies on a variety of analytical methods and transient expression platforms to provide customers with multidimensional molecular design and evaluation, ranging from antibody humanization, activity analysis to druggability evaluation.The Hangzhou R&D Center has a self-developed licensable high-expression stable cell line development platform (Haoyue) and process development platform.The pilot production base has well-established GMP production lines of 250L/500L for antibody DS and DP  as well as a GMP production line of 100L for ADC DS, capable of delivering antibody and ADC toxicology batch samples from DNA within 7 and 8 months, respectively.The company is also building a commercial production line of 6*2000L for antibodies  and a commercial production line of 500L for ADCs , which will be put into operation in 2024.

After years of dedicated efforts, we have garnered the trust and loyalty of numerous esteemed clients through our excellent service and reputation. We aspire to become a leading CDMO service provider not only in China but also globally, aiming to provide our clients with the highest quality solutions and support them in achieving remarkable accomplishments in the field of drug development.For more details, please visit the company's website：www.hs-biopharm.com

友情提醒

关于华人抗体协会的Industrial Frontier讲座系列

Webinar系列自2017年年中启动以来，主要围绕抗体药从研发到上市的整个产业链进行设置。本期的Industrial Frontier Webinar Series是我们推出的最新的Webinar讲座系列，目的是为华人抗体协会企业会员对该企业最新的技术平台提供一个分享的平台。

Webinar目前采用Zoom在线系统：https://www.zoom.com/ 每个webinar总时长为1小时-1个半小时，采用presentation + 15分钟 Q & A的形式进行，以增进观众与报告人的互动和交流。讲座的幻灯片以及讲座时使用的语言将根据报告人的偏好采用中文或者英文。

Industrial Frontier Webinar Series系列将对公众免费开放。请点击二维码注册讲座，或者请登录https://chineseantibody.net/cas-live-webinar-series-industry-frontier/或点击文末阅读原文（Read more)免费注册参加这个webinar。注册后会收到确认和提醒邮件, 可直接点击邮件中的webinar链接进入讲座。每次webinar过程中， 协会鼓励和欢迎注册听众进入webinar微信讨论群。听众可以通过讲座系统平台或者微信群平台向主讲人提出或讨论问题。请在线的会员充分利用实时webinar的机会与主讲人积极的问答互动。

赞助与合作机会 

华人抗体协会欢迎抗体领域的企业成为华人抗体协会的企业会员，有意参与的公司请联系：sponsorship@chineseantibody.org。协会将为企业会员提供宣传展示自己公司的机会。

关于华人抗体协会

Webinar 组织筹备：徐竹轩

Webinar报道: 朱高峰、陈雨欣

Banner设计：吴思源

网站更新：刘晓峰

微信编辑：钟升威，张琳

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LinkedIn宣传：马捷