2021年4月13日，圣地亚哥，上海——保诺-桑迪亚，一家由安宏资本领投，全球领先的提供药物发现、开发服务的公司，今日宣布无锡研发中心顺利完成第一个制剂临床样品GMP项目生产。此次的生产项目在公司质量体系的检测下零缺陷通过，启用了具有6,000万口服剂型单位的生产设施。
“这是我们在中国开发和生产能力的重要里程碑。我们已经实施了完整的质量体系，要求包括生产，质量管理，项目管理和研发运营等所有部门共同努力，并遵守一套明确的操作程序 ”，保诺-桑迪亚全球CEO 董海军博士说，“这项成就证实了保诺-桑迪亚的企业质量文化，并说明了无锡工厂的GMP生产能力可以支持从药物发现到生产的所有过程。”
保诺-桑迪亚无锡研发基地于2020年9月正式投入使用。占地面积约30000平方米，包括化学合成、生物、DMPK、药理以及2000平方米的制剂GMP车间。
“非常感谢惠山生命科技产业园、惠山区和无锡市政府对我们无锡新研发中心的大力支持。”董海军博士说道，“无锡新研发中心将是保诺-桑迪亚下一阶段增长的引擎之一。”
保诺-桑迪亚全球CMC解决方案（中国）总裁李建昌博士说：“我们对无锡研发中心的发展非常乐观。我们将继续扩大和发展我们的GMP生产能力以支持未来的项目，从而帮助我们的合作伙伴为患者开发更多新的药物”。
该项生产能力扩充了保诺-桑迪亚已有的药品生产能力——位于圣地亚哥的药品制造工厂，该工厂已有25年的生产和审计历史（包括FDA）。目前，保诺-桑迪亚的全球药品生产能力超过2.2亿片和5000万粒胶囊，支持包括美国和中国在内的全球Ⅰ-Ⅲ期临床样品生产。符合中美申报GMP生产要求（FDA & NMPA），并支持95％以上固体口服剂型的生产，包括：难溶性API、儿童制剂、高活制剂、以及吸湿和光敏产品等。
关于保诺-桑迪亚
保诺-桑迪亚，安宏资本旗下投资企业之一，是业内领先的合同研究、工艺开发和生产公司 (CRDMO)，专业为生物制药客户提供全面整合服务，支持药物发现、开发和生产（包括原料药和成品药）。作为全球第三大 CRDMO 公司，保诺-桑迪亚的 10 大办事处遍布全球，旗下拥有 2000 多名员工，在中国和美国开展主要业务。
保诺-桑迪亚在大小分子发现、开发和放大方面拥有核心专业知识，支持 IND 申报，拥有独特的专利技术平台（例如不溶性化合物生物利用度增强平台）。公司在中国和美国均设有研发中心和生产基地。保诺-桑迪亚采用“一站式”运营模式，有效帮助生物制药客户加快发现进程并降低开发风险，从而创造更高价值的药物。
保诺-桑迪亚由安宏资本领投，Bridgewest Business Group 为共同投资者。
关于安宏资本
安宏资本成立于 1984 年，是全球规模最大且最富经验的私募股权投资基金之一。自成立以来，安宏资本在 41 个国家完成了超过350项私募股权交易。截至 2020 年 6 月 30 日，公司资产管理规模达 584 亿美元。公司在全球四大洲 12 个国家设立了 15 个办公室，并拥有一支超过 200 名专业投资人士的国际团队，业务遍布北美、欧洲、拉丁美洲和亚洲。公司专注于五个核心投资领域 －商业和金融服务业，医疗健康，工业，零售、消费品与休闲，以及科技、媒体和电信业。35 年以来，安宏资本致力于国际投资市场，始终与管理团队保持协作，推动被投公司现收入和利润的可持续增长。
关于 Bridgewest Business Group
Bridgewest Business Group 成立于 1999 年，是一家封闭型投资公司，旨在通过应用卓越的行业经验、专业的运营知识和大量的金融资源，创造长期价值，从而吸引投资机会。集团的全球投资覆盖四个职能领域，包括私募股权、房地产、资本市场和金融服务。私募股权投资主要集中在生物技术、无线通信、物联网基础设施和半导体领域。Bridgewest 总部位于加利福尼亚州圣迭戈，投资业务遍布美国、欧洲、亚洲和大洋洲。
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BioDuro-Sundia Completes First GMP Drug Product Manufacturing at New China Site
--Team scores perfect quality record, initiating production facility with capacity of 60 million oral dosage form units—
SAN DIEGO and SHANGHAI, April 13, 2021 – BioDuro-Sundia, a leading drug discovery and development services organization backed by Advent International, announced today it has successfully completed its first GMP drug product clinical batch manufacturing at the company’s new R&D center in Wuxi China. The production received a perfect score within the company’s quality system, with zero corrective and preventative actions, initiating the site’s 60 million unit production capacity for oral dosage forms, including tablets and capsules.
"This is a major quality milestone for our development and manufacturing capacity in China. We have implemented a full quality system, requiring all departments—manufacturing, quality, project management, and local operations—to work together and adhere to defined set of operating procedures,” said Haijun Dong, PhD, global CEO for BioDuro-Sundia. “This achievement confirms the quality culture of BioDuro-Sundia and it gives our Wuxi facility the GMP capacity needed to support our clients from discovery all the way through manufacturing."
BioDuro-Sundia’s R&D Wuxi site opened in September of 2020 as a fully integrated facility. The site covers an area of 30,000m2, including chemistry, biology, DMPK, pharmacology and 2,000m2 dedicated to GMP manufacturing.
“The opening of our new Wuxi site has received tremendous support from the R&D park, the Huishan district and Wuxi municipal government, for which we are very grateful,” added Dong. “The new site will be one of the major engines for our next phase of growth.”
"We are very optimistic about the future of our Wuxi R&D center,” said Jim Li, PhD, President of Global CMC Solutions, China for BioDuro-Sundia. “We will continue to invest and grow our GMP production capability to support future programs, allowing us to help our pharma partners develop new medicines for patients in need.”
The new capability joins the company’s existing drug product manufacturing facility based in San Diego, which has 25 years of manufacturing and audit history (including FDA). Together, BioDuro-Sundia’s drug product manufacturing capacity now exceeds 220 million tablets and 50 million capsules, supporting Phase I-III clinical studies across the globe, including US and China. GMP manufacturing is compliant with FDA and NMPA regulations and supports >95% of all solid oral solid dosage forms, including: poorly soluble APIs, pediatric formulations, high potency formulations, and hygroscopic and photosensitive products.
About BioDuro-Sundia
BioDuro-Sundia, an Advent International portfolio company, is a leading contract research, development and manufacturing organization (CRDMO) that provides biopharmaceutical partners with fully integrated services to support drug discovery, development and manufacturing for both drug substance and drug product. The company is the industry’s third largest, with major operations in China and the US—featuring more than 2,000 employees and 10 global sites.
Core expertise includes small and large molecule discovery, development and scale up, support for IND submission, and unique technology platforms such as bioavailability enhancement of insoluble compounds. The company has research sites, as well as GMP manufacturing facilities in both China and the US. The one-stop-shop operation helps biopharma partners across the globe to significantly accelerate discovery and de-risk development to create higher value outcomes.
BioDuro-Sundia investment is led by Advent International, with backing from Bridgewest Business Group.
About Advent International
Founded in 1984, Advent International is one of the largest and most experienced global private equity investors. The firm has invested in over 350 private equity transactions in 41 countries, and as of June 30, 2020, had $58.4 billion in assets under management. With 15 offices in 12 countries, Advent has established a globally integrated team of over 200 investment professionals across North America, Europe, Latin America and Asia. The firm focuses on investments in five core sectors, including business and financial services; health care; industrial; retail, consumer and leisure; and technology. After 35 years dedicated to international investing, Advent remains committed to partnering with management teams to deliver sustained revenue and earnings growth for its portfolio companies.
About Bridgewest Business Group
Founded in 1999, The Bridgewest Business Group is a closely held investment company that seeks to create long term value through application of superior industry knowledge, operational expertise and significant financial resources to attractive investment opportunities. The Group structures its global investments across four functional areas including private equity, real estate, capital markets and financial services. The Group's private equity investments are primarily in biotech, wireless communications, infrastructure for IoT, and semiconductor. Bridgewest is based in San Diego, CA and has investments across the USA, Europe, Asia and Australasia.