岭南创新药开发学术交流会圆满落幕

6月28日,由广东省药学会主办,桑迪亚医药技术(上海)有限责任公司携手广东省药学会制药工程专业委员会联合承办的岭南创新药开发学术交流会在广州汇华希尔顿逸林酒店隆重举行。会议共吸引了来自全国各地的研发、生产、科研的300多位专家、代表参加,深刻探讨了创新药的发展方向以及策略。 

广东省药学会秘书长郑志华先生在致欢迎词中表达了对创新药发展前景的展望,他提到:一系列医药行业政策法规的贯彻实施,不仅有利于制药企业提升药物研发创新技术水平,加速医药产业结构调整,还将有利于全面提升药物整体质量水平。他提出希望像桑迪亚这种具有丰富创新药开发经验的CRO可以助力广东省的企业更高效的发展创新药研发。制药工程专委会秘书长王霆先生在致欢迎词时也表示,随着国家对于创新药政策法规的贯彻实施,CRO公司的系统注入将会是广东省医药生态未来的一个发展方向,不仅有助于完善医药研发结构,活跃医药学术氛围,还将大力推动研发企业的强势发展。

桑迪亚CEO李建昌博士致欢迎词时表示:希望能通过本次会议搭建一个产学研相结合的平台,共同探讨创新药研发中的新技术新方法,研讨技术细节分享案例和经验,剖析创新药发展的未来。同时,李博也分享了桑迪亚作为CRO公司在为客户提供创新药研发服务过程中遇到的各种案例,希望利用桑迪亚成熟而完整的创新药物临床前研究开发平台为更多合作伙伴提供全方位、一站式新药研发服务平台及专业的技术支持,降低新药研发成本,提高药物研发效率,期待为新药研发贡献一份力量!

(张绪穆教授,南方科技大学生物医药研究院教授,院长)

张绪穆教授通过分析当前制药行业发展现状来深刻阐述了绿色药物合成的重要性和迫切性。张绪穆团队在不对称氢化的工业化应用领域上的研究处于领先地位,如重大药物雷米普利、度洛西汀和西他列汀中间体的绿色合成新工艺,工业化应用的规模大、污染小、效益高。其中“重大药物绿色合成”项目,融合前沿的药物绿色合成理论、先进的药物绿色合成方法与策略,借助催化剂和中间体实现药物的绿色合成,在通用名药方面切实实现了若干重大药物的高质量、低成本、低污染生产。

(严启峰博士,太景生物科技股份有限公司药物化学部暨化学发展部副主任)

严启峰博士根据自己在创新药研发中的丰富经验给我们分享了创新药物开发的成药性考虑与策略。严博在药物化学设计、合成工艺开发以及申报资料撰写方面拥有非常丰富的经验和技术能力,他通过案例详细的分享了在创新药研发过程中如何从确认HIT化合物到延展HIT化合物,从HIT 到 LEAD,再到LEAD OPTIMIZATION,以及分享了在这个过程中自己是如何做到在保证化合物具有较高活性和较好选择性的同时,又是如何做到化合物具有较好的治疗值。

(楼方舟博士,王宏林团队研究员)

王宏林团队在银屑病研究上处于全球领先地位。该团队研发出全球首款抑制TH17分化的I类新药CKBA, 通过研究传统药物乳香中活性小分子化合物AKBA的作用靶点和作用机制,从而找到干预银屑病的新靶点和新机制。 目前该药物已于2019年4月15日获批临床。

(邹志扬博士,桑迪亚VP,DMPK部门负责人)

邹志扬博士作为DMPK部门负责人曾帮助客户完成数十项临床前药代动力学的IND申报工作, 此次会议上,邹博以个人经验为基础,以及参考FDA最新对在研药物的审核建议,为我们系统地解读从体外代谢到体内药代/组织分布试验及NON-GLP毒理试验研究,再到生物分析方法学验证及药物代谢产物鉴定分析等方面的试验设计及法规要求。

(王永辉博士,复旦大学药学院特聘教授)

王永辉教授课题组现主要研究方向为创新靶点小分子药物研发,特别是自身免疫性疾病和癌症免疫治疗小分子药物的发现与研究。在此次会议上,王教授详细讲述了如何发现RORGT抑制剂和激动剂,并解释了RORGT抑制剂和激动剂的作用机理,以及怎样把一个抑制剂变成激动剂。

(万昭奎博士,凌科药业(杭州)有限公司CEO)

凌科药业是业内冉冉升起的明星企业,万昭奎博士作为凌科药业的CEO,相信万博对医药市场和中国创新药的发展和医药研发的现状与机遇有着自己独到的见解。在会上,万博通过各种数据向我们说明了新药创新势在必行,以及市场赋予创新药的回报;随着中国医药市场的需求近年来持续增加,政策红利等因素的不断刺激,中国的创新药发展迎来了新机遇,万博士表示对我国的创新药物研发前景持乐观态度,尤其CRO的服务水平开启了中国新药研发的春天,培养了大量的人才,万博也特别强调了CRO对医药行业的重大作用。

(李红博士,桑迪亚制剂部执行总监)

创新药物今年来IND数量陡增,形势大好。但制剂行业仍面临诸多挑战。针对不可发展性,李博士结合实际案例给出一系列创新药制剂研究中从临床前到商业化的策略,并就部分细节问题在会后与现场参会者互动交流。

(张克坚博士,中山大学药学院教授,广东华南新药创制中心首席科学家)

通过分析FDA的特殊审批通道,同时对比美国、欧盟、日本等地区不同审批政策,张博士向我们展示了一些列FDA加速审批的新政,国内申报快速审批策略以及国内的审批制度等。

(谢雨礼博士,微境生物科技有限公司和苏州偶领生物医药有限公司CEO)

抗肿瘤药物一直是新药研发的热门靶点,肿瘤靶点药物占FDA所有获批药物的比例在不断增加,其发展空间不可估量。谢博士分析了当前环境下最热门的抗肿瘤药物研发的新趋势,并预测了未来抗肿瘤药物的发展方向。

(任宇鹏博士 桑迪亚高级总监,分析部负责人)

任宇鹏博士就IND项目中的CMC研究要求即准备毒理批、质量研究和积累数据准备等工作展开了详细的解说,并结合案例分享了桑迪亚在CMC质量研究中的经验和成绩。

在宋燕博士主持的圆桌“如何提高创新药研发的成功率,如何管控新药研发的成药风险”的论坛中,各位嘉宾聚焦于全球创新药研发趋势,以及中国创新药研发新政,深刻探讨了在当前模式下创新药研发策略。吴俊军博士提到借助CRO的经验,经常与CDE的沟通,可以节省很多时间,少走弯路。针对国内目前创新药靶点选择的盲从性,聂彪博士则认为应该根据自身的研发经验,关注临床需求导向,立足于自己的项目优势来选择。新药研发中的IP保护是一个关键点,万昭奎博士对桑迪亚健全的IP保护制度给与了高度的评价。在讨论中美双报的趋势和策略时郭建军博士则认为选择专业的申报团队是取胜的一个关键点。嘉宾都针对自己实验工作经验进行了分享,现场气氛热烈。

创新药研发为医药创新带来无限可能性。通过本次论坛,不仅得以把各位嘉宾在创新药研究领域的多年成果与业界同仁分享,同时,结合中国本土新药研发现状,贡献了更多关于创新药物研究、生产、质量控制以及注册审批方面的有益思考。让我们共同期待,革新药物研发与医疗服务,更好造福人类!

关于桑迪亚医疗科技集团股份有限公司

桑迪亚医疗科技集团已经建立起成熟而完整的创新药物临床前研究开发平台,可以为国内外客户提供从候选物到IND注册申报的“一站式”的整套临床前服务。该平台集药学、药理学及注册申报、项目管理于一体,有效整合了桑迪亚已有的化学工艺研究、原料药及药物分析方法研究、制剂研究与开发、DMPK研究、药理学研究、注册申报等各子平台。

David Preston
David Preston

Chairman

David Preston has had 38 years of healthcare experience with publicky Traded and Private companies in the fields of Phammaceuticals, Animal Health and Biotechnology as a Board Member. The last 30 years of his xperience has been in China, Taiwan and Hong Kong building successful igh growth businesses. David Has been Chaiman and CEO for Greater China for Sanofi and Boehringer – Ingelheim as well as the Janssen Corporation since 1991 in China. During this time he build high Growth ousinesses in China through diversified strategies in Innovative Pharmaceuticals. branded Generics. Biotechnology. and Animal Healthcare.

Key highlights in this period indluded building of the first Westem Multinational Biotechnoloqy C.M.O. facility as well as obtaining the first Test CM.OJ MAHI license. Establishment of a number of High tech Vaccine Plants, and R and D facilities in in the field of Animal Health. Signing and development of numerous JV’s as well as Wholly owned Subsidiaries. Mergers and Acquisitions across Phamaceutical’s. Animal Health. and Biotechnology industries

David’s achievement’s in the Healthcare industry and it Growth and development in China is widely recognized By the Chinese Govemnment and the City of Shanghai In 2013 he was awarded the Silver Magnolia ollowed in 2015 the Gold Magnolia award. This was then followed by being awarded in 2017 the Honorary Citizen of Shanghai by 40th People’s Municipal Congress of Shanghai. David Holds a Business Science Degree

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Filippo
Filippo de Vecchi

Director, Advent Partner

Filippo de Vecchi joined Advent in February 2000. He started in the Advent São Paulo office, then moved to Milan in 2002, in 2012 set up the Advent office in Shanghai and in 2016 set up the Hong Kong office. Before joining Advent, he was a senior consultant with Value Partners, in São Paulo and Milan, focusing on strategy and organization in the automotive, energy, cable and media sectors. He began his career at Wasserstein Perella & Co., working as an analyst in the Mergers and Acquisitions department in London and New York. Filippo holds an undergraduate degree cum laude in Economics, with a major in Business Administration, from the LUISS University and an MBA from Columbia Business School, where he currently serves as a member of the Board of Overseers.

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Andrew Li
Andrew Li

Director, Advent Partner

Andrew Li joined Advent in 2012. He previously worked at Warburg Pincus, HSBC PE, Solera Capital and Credit Suisse where he focused on the retail and consumer, healthcare, industrial, and energy sectors. Andrew has worked in finance and private equity throughout the U.S. and China since 1999. Andrew holds a BA from Middlebury College and an MBA from Harvard Business School.    

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Michael Miltenberger
Michael Miltenberger

Director, Advent Partner

Michael Miltenberger  joined Advent in 2011 as an associate on the healthcare team. Following business school, he rejoined Advent’s Boston office, focusing on healthcare investments. Prior to Advent, Michael was a consultant at McKinsey & Company in their Washington DC office, serving a range of healthcare and private equity clients. Michael earned a BA, cum laude, from Harvard College and an MBA from Harvard Business School, graduating with High Distinction as a Baker Scholar and a Harvey Fellow.

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Masood Tayebi
Masood Tayebi, PhD

Director, Operating Partner

Dr. Masood Tayebi is the Founder of BioDuro. He currently serves as CEO of a nationwide real estate portfolio and is a Partner and Chief Executive Officer of the Bridgewest Group. Prior to BioDuro, Dr. Tayebi was Co-Founder and Chairman of Wireless Facilities, Inc. (NASDAQ: WFI), a global leader in telecommunications outsourcing.

Achievements
  • Co-Founder of Wireless Facilities, Inc.

  • Co-Founder of BioAtla, LLC

  • Recipient of the Ernst and Young 2000 Entrepreneur of the Year award in San Diego

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Kewen Jin
Kewen Jin, PhD

Director, Operating Partner

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Amit patel
Amit Patel

Director, Operating Partner

Amit Patel has twenty years of healthcare industry experience with publicly-traded, private equity-backed, and start-up companies in the capacity of executive, board member, advisor, and investor.  He is currently Executive Chairman of Azurity Pharmaceuticals (a NovaQuest Capital Management portfolio company) and a board member at BioDuro (Advent International portfolio company), Tergus Pharma (Great Point Partners portfolio company) and Calyptus Pharma.  Recently, Amit was SVP & President of Dosage Form Solutions at Capsugel, a KKR portfolio company (purchased from Pfizer in 2011 and sold to Lonza in 2017).   

Prior to Capsugel, he worked at Dr. Reddy’s Laboratories, Inc. as EVP & Head of North America, and SVP & Head of Global Corporate Development & Strategic Planning. Earlier, Amit was VP of Corporate Development at CTIS, Inc., and Co-founder & CEO of MedOnTime, Inc. (acquired by CTIS).  He started his career as a strategy consultant with Marakon Associates. Amit holds an M.B.A. degree from Harvard Business School, a B.S. degree in Economics from the Wharton School of Business, University of Pennsylvania, and a B.A.S. degree in Systems Engineering from the Moore School of Engineering, University of Pennsylvania.

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Haijun Dong
Haijun Dong

Chief Executive Officer

Dr. Haijun Dong currently serves as global CEO of BioDuro-Sundia. He previously was CEO for over 5 years at PharmaBlock Sciences Inc., a public company listed in the Shenzhen Stock Exchange (300725.SZ). The positions he held prior to PharmaBlock includes, among others, Senior Scientist at Boehringer Ingelheim Pharmaceuticals in Ridgefield, Connecticut; Senior Principal Scientist at Roche in Nutley, New Jersey; Head of DMPK and Drug Safety at Roche China R&D Company in Shanghai; Chief Operating Officer of Eli Lilly China R&D Center in Shanghai.

Dr. Dong received his PhD in organic chemistry from the University of Washington in Seattle, Washington, and MBA from China Europe International Business School in Shanghai. 

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Teo Nee Chuan
Teo Nee Chuan

Chief Financial Officer

Teo Nee Chuan joined us in May 2021 as chief financial officer. Prior to joining us, he was chief financial officer of Huazhu Group from November 2015 to May 2021, and was the chief financial officer for Rnomac International Limited, from November 2011 to August 2015. Mr. Teo worked in DDB Greater China Group, was appointed as the chief financial officer in September 2009, and was additionally appointed as the director of operations in January 2011. He previously served in Focus Media Group and was appointed as the financial deputy director in June 2007. Prior to that, from September 1994 to May 2007, Mr. Teo worked at Ernst & Young and Ernst & Young Business Services Ltd. in various positions in Kuala Lumpur and Toronto, including as a senior manager in the Transaction Advisory Services. Mr. Teo has been an independent director of 111, Inc. (a company listed on the NASDAQ, ticker symbol: YI) since September 2018. Mr. Teo received his Bachelor of Science in Accounting and Financial Analysis degree from The University of Warwick in the United Kingdom in July 1994. He is a Chartered Certified Accountant in the United Kingdom, who has obtained his qualification in July 1998 from The Association of Chartered Certified Accountants, and is a Certified Public Accountant in the United States and Hong Kong, who has obtained his qualification from American Institute of Certified Public Accountants in May 2002 and Hong Kong Society of Accountants in October 2003, respectively.

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TJ
TJ Deng, PhD

President, Discovery

Dr TJ Deng joined BioDuro in the initial stages of the company and helped BioDuro grow to an industry leading discovery services organization. He established and managed several scientific departments, including DMPK, before transitioning to a leader of the business and operations functions. Prior to joining BioDuro, Dr. Deng spent six years at PPD, in positions with increasing responsibilities from scientist to scientific manager.

Achievements

 

 

  • Developed the extractable/leachable capabilities at PPD
  • 18 years industry experience

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Kent Payne
Kent M. Payne, PhD

Chief Executive Officer

Kent is distinguished as a business operator and leader in areas of sales, commercial manufacturing and product development. He has extensive executive experience in M&A as well as successfully running, start up, growth and turn around businesses. This includes both Fortune 500 and Private Equity environments. He combines strong business leadership, successful P&L track record, and technical background to strategically lead and grow enterprise value across Biotechnology and Pharmaceutical market segments. He has successfully led the geographic expansion of businesses into Europe, Asia, and South America in addition to the United States.  He currently serves as CEO for BioDuro-Sundia, LLC (an Advent International company). He also currently serves as a board member for Goodwin Biotechnologies (a Signet Healthcare company). 

Prior Roles

  • President, Global CMC Solutions BioDuro-Sundia, a global
    CRDMO
  • CEO Socorro Pharmaceuticals, LLC, a generic pharmaceutical
    company
  • President Americas, Qualicaps Inc.(a Mitsubishi Chemical Holdings subsidiary)
  • Principal Consultant and Partner at CoreFactor LLC, providing executive strategic, licensing and operational advisory services to clients.
  • Vice President/General Manager Catalent Pharma Solutions, Inc. (a Blackstone Group company formed in 2007, formerly part of Cardinal Health)
  • Progressive leadership responsibility at: Novartis, Monsanto and G.D. Searle.  

Prior Brand Position

  • Board Advisor Vitruvias Therapeutics
  • Board Member Qualicaps, Inc. (a wholly owned subsidiary of
    Mitsubishi Chemical Holdings)
  • Board member Technophar, Inc. (a wholly owned subsidiary of
    Mitsubishi Chemical Holdings)
  • Board Advisor, Corporate Strategy Office, Life Science Institute
    Inc. (a wholly owned subsidiary of Mitsubishi Chemical Holdings)
  • Non-executive Chair and Board Member PDS Biotechnology·        (PDSB: NASDAQ)

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John Phillips
John Phillips

Vice President, Business Development (US & EU)

Coming soon…

Achievements

 

  • Coming soon…

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Roy Xu
Roy Xu

Chief Strategy Officer

Roy has over 25 years of healthcare industry experience.  He started his career as an orthopedic surgeon.  Roy joined Eli Lilly as a sales rep in 1997.  Since then he has had various roles in market research, business intelligence, BU head, strategy, regional general management, business development etc., both at Eli Lilly and Boehringer Ingelheim (BI).  Roy also spent more than two years in Germany where he was BI’s Director of Corporate Business and Enabling Strategy.

Roy obtained a bachelor’s degree in Clinical Medicine at Zhejiang Traditional Chinese Medicine University, and an MBA from Zhejiang University.

Achievements

 

  • 25 years of healthcare industry experience including Eli Lily and Boehringer Ingelheim. 
  • Former Director of Corporate Business & Enabling Strategy at oehringer Ingelheim in Germany.

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San Diego

BioDuro- San Diego Facility

Our San Diego site is our corporate headquarters. The facility is home to BioDuro-Sundia’s drug product development technologies and has 9 GMP clean rooms. Development and manufacturing operations are conducted for projects up to Phase III clinical trials.

Size: 44,000 sq. ft.
Featured capabilites: Tableting, Coating, Hot Melt Extrusion, Spray Dried Dispersion

11011 Torreyana Rd.
San Diego
CA 92121
United States

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Beijing

BioDuro Beijing

Operating since 2006, our Beijing site is home to BioDuro-Sundia’s first wet chemistry operations. With 300 regular fume hoods and 18 scale-up chemistry hoods the Beijing facility houses most of BioDuro’s chemistry operations, while also hosting labs for biology and monoclonal antibody discovery.

Size: 100,000 sq. ft. 
Featured capabilities: Radioactivity Lab, Monoclonal Antibody Discovery, Medicinal Chemistry

No. 29 Life Science Park Road
Changping District Beijing,
102206
P.R. China

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Shanghai-Waigaoqiao

BioDuro- Shanghai Facility

Established in 2012, BioDuro-Sundia’s Shanghai facility has been growing with its departments. The cutting edge facility contains labs for ADME, bioanalysis, in vitro assays and translational research. The site includes a 18,000 sq. ft vivarium and 20,000 sq. ft of office space.

Size: 92,000 sq. ft.
Featured capabilities: Scale-up Chemistry, Discovery Biology, DMPK, In Vivo Pharmacology

No. 233 North Fu Te Road
Waigaoqiao Free Trade Zone
Shanghai, 200131
P.R. China

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Cathy Yen
Cathy Yen

Director, Operating Partner

Cathy joined the Board of Directors of BioDuro-Sundia in 2020, with the Advent-led acquisition of Sundia and creation of BioDuro-Sundia. Prior to that, she was Chairman of the Board at Sundia Meditech Group, where she was the key architect of Sundia’s strategic vision and growth. Under her leadership, Sundia solidified its position as one of the leading pre-clinical CROs in China.

Prior to Sundia, Cathy had a distinguished career as a seasoned venture capitalist, having led numerous investments in high-growth companies in Asia. Cathy served as a Partner of AsiaVest Partners, TCW/YFY Ltd., a global venture capital firm, for over a decade, Vice President at Global Financial Services, Vice President at Crimson Ventures/Chinatrust Bank and Senior Manager at Fortune Capital. She brings over 20 years of experience in corporate finance, accounting, strategic planning and private equity investments. 

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Wuxi

Wuxi - BioDuro

Established in 2019, BioDuro-Sundia’s fully integrated discovery facility located at the heart of Jiangsu Wuxi Life Science & Technology Industrial Park with plans of growing staff to 1000+ scientists.

Size: 300,000 sq. ft.
Featured capabilities:
Discovery Chemistry & Biologics, Biology, DMPK, Pharmacology, CMC Services

no.1699,Huishan avenue
Huishan Economic 
Development Zone,Wuxi
P.R. China

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Hebei

Hebei - Sundia

Established in 2011, this pilot plant this handles mg to kg scale up.

Size: 45,208 sq. ft.

Featured capabilities: SFFS Chemistry: mg to kg scale up
(150 hood)

238 Changjiang Road
Shijiazhuang,
Hebei province
P.R. China

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Taiwan

Taiwan Sundia

Our site in Taiwan supports Discovery Biology and Chemistry.

Size: 3,352sq.ft.
Featured capabilities: Chemistry;Biology

7F, No. 107, Sec. 4
Ren Ai Road,
Da-an District,
Taipei, Taiwan

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Bengbu

Bengbu - Sundia

Scheduled to open in fall of 2021, this site is designed to handle non-GMP manufacturing, advanced intermediates, GMP starting material(RSM) for IND enabling sttudies as well as clinical and commercial use. 

Size: 43,056 sq. ft.
Featured capabilities: Intermediates, GMP starting materials

Mohekou Industrial Park,
Huaishang District, Bengbu, 
Anhui province
P.R. China

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Shanghai-Changli

Shanghai Changli

Our Shanghai-Changli site supports FTE cheimistry and advanced Discovery Chemistry processes.

Size: 71,844 sq. ft.
Featured capabilities: Chiral Analytical Lab, Analytical and Purification Lab, NMR Lab, Synthetic Lab, Parallel Synthesis Lab, Flash Chromatography Lab..(380 hoods)

法拉第路251号8号楼;
Building 8, 251 Faladi Road,
Zhangjiang Hi-Tech Park,
Shanghai, China
P.R. China

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Shanghai-Halei

Shanghai Halei

Opened in 2018, BioDuro-Sundia’s Shanghai-Halei contains facilities that support both Discovery and CMC parts of the drug development & manufacturing process. Facilities include amorphous dispersion techniques like SDD & Discovery Biology.

Size: 31,043 sq. ft.

Featured capabilities: Formulation : Preformulation, Wet Granulation, Compression, Tablet Coating, Fluid Bed Room, Spray Dryer, Hot Melt Extrusion, Dry Granulation Biology: Kinase selectivity, Cellular Assay, Compound Screen, Immune oncology service

哈雷路917弄1号;
Building 1, 917 Halei Road,
Zhangjiang Hi-Tech Park,
Shanghai, China

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Shanghai-Kelun

Shanghai Kelun

Established in 2008, our Shangahi-Kelun site is desgined to handle advanced process and analytical chemistry including process GMP and non-GMP kilo lab.

Size: 98,503 sq. ft.

Featured capabilities: general chemistry; Process: GMP & non-GMP kilo lab, Process analytical, Column Purification , Flow Chemistry. Analytical: 22 HPLC/UPLC. 8 Stability Chambers . DMPK: animal PK, Bioanlysis Metabolite ID, In Vitro Studies, In- Life studies

Building 8, 388 Jialilue Road,
Zhangjiang Hi-Tech Park,
Shanghai China, 201203

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