生物制剂

致力于技术优化,为生物制剂的发现和开发提供最佳支持服务。

对我们的专业技术感兴趣?

概述

保诺-桑迪亚拥有综合抗体发现能力,可实现与目前市场供应产品的差异化。建立了多种技术,可从各种各样的抗体基因源中发现抗体,包括免疫动物、人类患者和合成DNA。将采取创新策略来克服治疗抗体发现领域中的痛点,目标是具备不仅将针对典型药物靶标而且针对更具挑战性的靶标最终开发生成抗体的能力,例如GPCR、离子通道以及甚至细胞内靶标。我们正建立一个具有独特实力和能力的最前沿抗体发现平台,以满足全球客户目前和未来治疗性抗体发现和优化的需求。

保诺-桑迪亚的优势

核心竞争力

专业设备

SYNTHETIC ANTIBODY合成抗体

人工智能(AI)驱动的抗体工程/演化

保诺桑迪亚把人工智能(AI)和合成抗体发现相结合,已创立了抗体发现平台。联合平台能使我们的生物制药合作伙伴缩短基于抗体的药物开发项目时间周期并改进质量,能够更快地推进到临床阶段。

联合平台可以采取高通量方式筛选100多亿的高影响力序列。  序列是全合成的,意味着它们是专门设计的抗体,具有优化的亲和力、特异性、稳定性和治疗可开发性。  平台尤其能用于疑难靶标,包括GPCR、离子通道和多肽-MHC复合物,这些始终无法开发成基于抗体的疗法。

AI驱动的抗体技术利用最新的人工神经网络算法、机器学习和分子动力学,模拟每种抗体的定向进化,最终生成优化的序列,这些序列可特异性且强有力地与靶抗原结合。这些AI导向的序列很快进入到实验筛选中。在庞大的潜在序列中,我们的平台选择最佳的子集,将其推进到筛选阶段。执行巨量的AI运算来选择更小但最佳的序列库,具有更高的抗体发现成功率。

保诺桑迪亚的先进合成抗体技术通过高速DNA基因工程,迅速将AI导向的进化结果转变成功能性抗体,这样在3-4周内可用于创建和筛选超过100亿的人合成抗体。  传统的非合成方法使用人免疫系统或其他动物来生成抗体,导致抗体的多样性和可开发性受到限制。“保诺桑迪亚的合成抗体筛选平台能够让我们发现最理想的抗体,其原因在于我们不受限于人或动物的免疫系统;我们可以设计通过定向进化优化的任何具有几乎无限的序列组合的抗体,我们确信采用具有良好开发特性的全人抗体框架作为开始,意味着我们更有可能推进到临床并很快实现这一点。”

我们也正与几家合作伙伴一起合作,将技术扩展到免疫细胞疗法的抗体设计,例如CAR-TTCR-T,这些是极具前景的免疫肿瘤学疗法,但在临床研究中已出现非预期结果和强烈的副作用,这大部分是由于次优抗体和连接子设计所导致。团队正运用其独特的抗体发现平台,快速发现和开发安全性和疗效特征改进的下一代CAR-T疗法。

下一代基于动物的抗体发现

保诺桑迪亚已成立了下一代基于动物的抗体发现平台,通过整合人源化小鼠、DNA/细胞免疫和单个B细胞技术,开展快速、高质量的治疗抗体发现。目标是建立一个全面高效的抗体发现平台,满足我们客户的多样化需求。

先进的免疫技术,诸如用抗原编码DNA免疫动物或表面抗原表达细胞等,是针对难以表达或纯化的抗原靶标的首选替代方法。通常来说,动物免疫可以产生高亲和力的抗体,但传统方法达到的融合效率较低。在保诺桑迪亚,我们使用电穿孔法进行DNA免疫和融合过程,来实现更优异的效率。

我们已开发了一种具备多种优势的免疫技术,尤其适合于如膜结合抗原、肿瘤相关抗原等抗原、免疫调节因子和GPCR

全人源转基因小鼠

随着基因操作技术的不断演化,小鼠抗体V基因可以用人基因替换,产生人源化小鼠。在治疗性抗体发现领域内,对此类小鼠进行免疫来生成含人V区序列的抗体方法,已获广泛采纳。

保诺桑迪亚目前已拥有用于人抗体生成的人源化小鼠。所有的内源性小鼠Ig片段已被删除,并由人Ig片段所替换,包括针对VHV/D/J基因和针对VLV/J基因。免疫应答测试已表明,人源化小鼠的表现甚至比正常小鼠略胜一筹。采用NGS分析这些Ig基因表达,并将其与在人体中的表达模式进行对比分析。结果显示人源化小鼠和人体中的表达水平相似。所有数据均支持人源化小鼠是作为人抗体生成的理想平台。这也可结合我们的DNA或细胞免疫方法,以实现更好的研究结果。

单个B细胞技术

单个B细胞技术已广泛用于感染性疾病的抗体发现。采用FACS技术可从患者中分离抗原反应性B细胞,可将每个B细胞分类到单个孔中。将抗原反应性克隆的VLVH基因拯救出来,用于重组抗体生产。最近,已改进了基因拯救程序,从而在更低的成本下实现更高的拯救率。

David Preston
David Preston

Chairman

David Preston has had 38 years of healthcare experience with publicly – Traded and Private companies in the fields of Pharmaceutical’s, Animal Health and Biotechnology as a Board Member. The last 30 years of his experience has been in China, Taiwan and Hong Kong building successful high growth businesses. David Has been Chairman 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 businesses in China through diversified strategies in Innovative Pharmaceuticals, branded Generics, Biotechnology, and Animal Healthcare.


Key highlights in this period included building of the first Western Multinational Biotechnology C.M.O. facility as well as obtaining the first Test C.M.O.[ MAH] 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 Pharmaceutical’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 Government and the City of Shanghai. In 2013 he was awarded the Silver Magnolia followed 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

President, Global CMC Solutions

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, South America in addition to the United States.

He also currently serves as a board member for Goodwin Biotechnologies (a biological contract manufacturer), and board advisor for Vitruvias Therapeutics (a specialty generic pharmaceutical business)

Achievements

  • CEO Socorro Pharmaceuticals, a generic pharmaceutical company
  • President Americas, Qualicaps Inc.
  • 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 Board Positions:
  • Board Advisor, Corporate Strategy Office, Life Science Institute Inc. (a wholly-owned subsidiary of Mitsubishi Chemical Holdings.
  • Board member for Technophar, Inc.; Qualicaps, Inc.
  • Non-executive Chair and Board Member PDS Biotechnology (PDS

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Tommy Broudy
Tommy Broudy, PhD

Executive Vice President, Marketing

Tommy Broudy joined BioDuro as Executive Vice President, Translational Sciences in 2018 following the acquisition of Molecular Response, a patient-derived tumor modeling company he cofounded in 2010. Tommy is now leading BioDuro’s translational oncology group, with focus on in vivo and in vitro oncology testing services that help more efficiently translate novel anti-cancer medicines into the clinic. Tommy previously served as General Manager of Crown Bioscience San Diego, where he led the US preclinical operation. Prior to that, Tommy served as Director at AltheaDx, working closely with the Business Development and R&D teams to establish gene expression-based companion diagnostics for oncology therapeutics. He also spent six years at Affymetrix, where he managed the company’s pharmacogenomic and toxicogenomic solutions in support of pharmaceutical R&D.

Achievements

 

  • Earned his PhD at Rockefeller University in the Laboratory of Bacterial Pathogenesis and Immunology
  • Held postdoctoral appointments at Rockefeller and Stanford University studying host/microbial genomics

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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/圣地亚哥

BioDuro- San Diego Facility

Our San Diego site is our corporate headquarters. The facility is home to BioDuro’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/北京

BioDuro Beijing
Operating since 2006, our Beijing site is home to BioDuro’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/上海-外高桥

BioDuro- Shanghai Facility

Established in 2012, BioDuro’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/无锡

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/河北

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/台湾

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/蚌埠

Bengbu - Sundia
Scheduled to open in fall of 2020, this site is designed to handle API manufacturing and additional expertise in intermediates, GMP starting material upto IND enabling sttudies

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

Mohekou Industrial Park,

Huaishang District, Bengbu, 

Anhui province
P.R. China

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Shanghai-Changli/上海-长利园区

Shanghai Changli

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

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/上海哈雷园区

Shanghai Halei
Opened recently in 2018, BioDuro-Sundia’s Shanghai-Halei contains facilities that supports 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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