PHARMA MANUFACTURING SA

编者按： 今年是药明康德成立25周年。从2000年一间650平米的实验室起步，如今的药明康德已成长为一家全球性CRDMO公司，并且还在持续建能力、扩规模，快速发展。我们的平台目前正承载着数千名客户的创新项目，加速新药好药不断问世，为患者带去生命的希望。 面对复杂多变的外部环境，25年来，药明康德如何一次次跨越周期，实现长期发展？ 面对不断涌现的新分子浪潮，药明康德又将如何前瞻洞察，布局未来？ 日前，行业媒体Pharma Manufacturing的主编Greg Slabodkin采访了公司联席首席执行官陈民章博士。陈民章博士拥有二十多年新药研发和生产管理经验，在多个全球新药的研发及商业化过程中发挥了重要作用。 陈民章博士认为，药明康德的战略很明确：跟随科学，跟随客户，跟随分子，“这是我们一体化CRDMO模式的核心，能够帮助我们始终立足行业前沿，不断为客户创造价值。”以下是他的详细洞见。 Greg Slabodkin：CRDMO目前面临怎样的外部环境？ 陈民章博士：CRDMO正在持续强劲增长。药明康德与初创公司和大型医药公司广泛合作，加速创新疗法问世，造福广大患者，并以此推动行业的发展。 我们专注于质量、速度和成本，持续助力生物技术公司和大型医药公司加快新药开发进程，提升研发效率，让新药、好药更快惠及患者。2024年，美国食品药品监督管理局（FDA）批准了50款新药，今年上半年继续批准了16款，彰显出行业合作正持续推动创新的步伐。 无处不在的创新驱动着新药研发，也对能力规模提出了更高的要求。随着创新药物分子的大小和复杂性日益增加，尤其是寡核苷酸、多肽、靶向蛋白降解剂（TPD）、抗体偶联药物（ADC）等新分子的出现，新药的整体研发进程——从化学合成到生产、质量控制和满足法规要求——都需要更丰富的知识和更先进的方法。 客户会找到药明康德，是因为我们有大量积累的know-how、专业能力和持续扩展的规模，能够从容应对这些复杂的分子挑战。同时，他们希望借助我们的平台控制开发成本、提高效率并降低风险。 Greg Slabodkin：药明康德在全球拥有多少基地设施？它们的位置和能力规模如何？ 陈民章博士：今年是药明康德成立25周年，我们已经从一间7000平方英尺（约650平方米）的实验室发展成为一家全球性企业。如今，我们在亚洲、欧洲和北美拥有20多个研发和生产基地。 例如，在美国，我们的圣地亚哥基地能为小分子原料药（API）和制剂提供从筛选、发现生物学、药理学、工艺研发，到GMP生产的卓越一体化服务。我们也正在特拉华州米德尔顿建设一个新的园区，专注于胶囊和片剂的临床及商业化生产、包装和测试，该基地预计将于2026年底前投入运营。 在欧洲，我们的德国慕尼黑基地专注于早期药物发现，并提供X射线晶体学、蛋白质供应和生物物理分析方面的定制化服务。 我们位于瑞士库威的工厂专注于制剂生产和包装，能够为后期临床和商业化规模生产提供灵活的服务。该基地预计将在2026年增加喷雾干燥能力，还将增加肠外药物生产和脂质纳米颗粒（LNP）相关能力。 在亚洲，我们也有多个运营基地。2024年，我们的新加坡基地开工建设，将为小分子、寡核苷酸、多肽和复杂的合成偶联药物提供原料药生产服务。该基地一期预计于2027年投入运营。 ▲药明康德新加坡基地已开工建设，一期预计于2027年投入运营 Greg Slabodkin：药明康德目前还在哪些方面进行投资，以支持未来的增长？ 陈民章博士：药明康德的战略很明确：跟随科学、跟随客户、跟随分子。这是我们一体化CRDMO模式的核心，能够帮助我们始终立足行业前沿，不断为客户创造价值。 我们当前投资的重点之一是建设新分子相关能力和产能。例如，我们的WuXi TIDES业务为寡核苷酸、多肽药物及相关化学偶联物（“TIDES”药物）提供一体化服务，覆盖API和制剂从发现到生产的全生命周期。 面对日益增长的市场需求，尤其是GLP-1领域的需求，WuXi TIDES将在2025年底前进一步提升多肽固相合成反应釜（SPPS）总体积至超过10万升，并计划在新加坡基地增加更多产能。 我们不断加快产能建设，还能更好地满足后期临床试验和商业化生产的需求。2025年3月，我们位于常州和泰兴的原料药生产基地以零缺陷顺利通过FDA现场检查。这两个基地是药明康德子公司合全药业（小分子CDMO）和WuXi TIDES的重要生产基地。到2025年底，我们小分子原料药的总反应釜体积也将超过400万升。 Greg Slabodkin：药明康德正在关注投资哪些技术？ 陈民章博士：WuXi TIDES是我们增长最快的业务之一，其全方位的CRDMO能力涵盖新型单体、连接体和配体、寡核苷酸、多肽以及复杂化学偶联物的工艺开发与任何规模的生产服务。这种一体化的方式能够简化TIDES药物开发流程，助力客户以更高效率、更低成本将创新疗法从概念推进至临床。 例如，我们在一个复杂的多肽-PMO（PPMO）偶联物项目中，通过多个团队平行推进，优化合成、偶联、制剂和分析方法，帮助客户在短短11个月内将候选药物推进到IND（临床试验申请）阶段。 在TPD化合物领域，我们也深耕多年。我们已与该领域的150多家公司建立了合作伙伴关系，合成了超过188,000种复杂的TPD化合物，其中70多种已进入临床前候选药物（PCC）阶段，10多种已进入后期开发阶段。 此外，我们积极拥抱绿色科技，大力推进连续化生产和酶催化等技术的应用，最大限度地减少化学品的使用，以满足快速增长的客户需求，并助力可持续发展。 Greg Slabodkin：合全药业如何继续拓展喷雾干燥分散（SDD）产能？ 陈民章博士：作为药明康德的子公司，合全药业泰兴原料药生产基地今年新增了一台PSD-4喷雾干燥器，进一步提升了喷雾干燥商业化生产能力。同时，我们的瑞士库威基地全新的喷雾干燥车间也正式破土动工，预计首台喷雾干燥设备将于2026年投入运营。 喷雾干燥分散是合全药业用于生物利用度提升的一项重要技术，能够支持从毫克级实验室规模到临床以及商业生产阶段吨级规模的喷雾干燥开发和生产，提供端到端的解决方案，帮助客户加快项目进程。 ▲泰兴生产基地新增一台PSD-4喷雾干燥器 Greg Slabodkin：对药明康德来说，可持续发展有多重要？ 陈民章博士：赋能客户是药明康德不变的初心，我们致力于与行业同仁携手构建更健康的世界。与大多数客户一样，我们将可持续发展的理念充分融入到战略和日常运营的方方面面。 近年来，我们在瑞士库威和德国慕尼黑基地加大对可持续发展项目的投资，比如太阳能利用及雨水回收。在全球各运营所在地，我们持续优化流程，在助力研发和生产的过程中大力推广绿色技术，例如连续化生产和酶工艺，持续提高能源利用效率，在业务运营中减少碳排放。 我们还与供应商合作，减少与采购相关的温室气体（GHG）排放，推动共建低碳供应链。今年，药明康德正式加入制药供应链倡议（PSCI），成为PSCI供应商合作伙伴。我们与客户和各方行业同仁携手合作，推动更可持续、更负责任的未来。 今年，我们提交的温室气体减排近期目标已成功通过科学碳目标倡议（SBTi）的审核认证。公司的可持续发展成就也获得了包括MSCI、EcoVadis、CDP和联合国全球契约组织（UNGC）在内的诸多全球权威机构的认可，我们对此由衷感到自豪。 中文内容基于行业媒体Pharma Manufacturing的报道，点击“阅读全文/Read more”即可访问原文页面。 Q&A: WuXi AppTec’s key investment focus is on expanding capabilities for new modalities With more than 20 R&D and manufacturing sites across Asia, Europe, and North America, WuXi AppTec offers integrated, end-to-end services through its Contract Research, Development, and Manufacturing Organization (CRDMO) platform. In 2025, the company is accelerating its global development and manufacturing capacity expansion, growing both total reactor volume of small molecule active pharmaceutical ingredients (APIs) and total reactor volume of solid phase peptide synthesizers. According to Minzhang Chen, co-CEO of WuXi AppTec, the essence of the company’s integrated CRDMO model is simple: follow the science, follow the customer, and follow the molecule. Chen has over 20 years of experience in pharmaceutical development and manufacturing, having played important roles in R&D and commercialization of multiple innovative drugs for global launches. Formerly the director of technical operations at Vertex, Chen earned a bachelor’s degree in chemistry from Peking University and a Ph.D. in organic chemistry from the University of Minnesota. In a Q&A with Pharma Manufacturing Editor in Chief Greg Slabodkin, Chen discusses tariffs as well as WuXi AppTec’s business strategy and investments amid external uncertainties.   Greg Slabodkin: What is the current business environment for the CRDMO industry? Minzhang Chen: The CRDMO industry continues to post strong growth. WuXi AppTec is contributing to this trajectory by partnering with startups and Big Pharma companies to speed delivery of new therapeutics to patients. By focusing on quality, speed, and cost, we help biotech and pharmaceutical companies accelerate drug development, enhance efficiency, and deliver new therapies to patients faster. The FDA approved 50 novel drugs in 2024 and 16 in the first half of this year, reflecting a sustained pace of innovation driven by such partnerships. As innovation continues to drive pharmaceutical R&D, the increasing size and complexity of drug molecules, especially new modalities like oligonucleotides, peptides, targeted protein degraders (TPDs) and antibody-drug conjugates (ADCs) require greater knowledge and sophisticated approach throughout the R&D process, from chemical synthesis to manufacturing, quality control, and regulatory compliance. Customers turn to us for our technical know-how, specialized expertise and scalable capacity in working with these complex molecules. They also look to us to help control costs, improve efficiencies and mitigate risks. Greg Slabodkin: How many facilities does WuXi AppTec have? What are their locations and capabilities/capacities? Minzhang Chen: This year marks the company’s 25th anniversary. We have built the company from a single 7,000 square-foot laboratory into a global enterprise. Today we operate more than 20 R&D and manufacturing sites across Asia, Europe, and North America. In the United States, for example, our San Diego site serves as a center of excellence in screening, discovery biology, pharmacology, process R&D, and GMP manufacturing for small molecule API and drug product. We’re building a new campus in Middletown, Delaware, dedicated to the manufacturing, packaging, and testing of capsules and tablets for both clinical and commercial distribution, which is expected to commence operations by the end of 2026.   In Europe, our Munich site focuses on early-stage drug discovery and also provides customized services in X-ray crystallography, protein supply, and biophysical analysis. Our Couvet, Switzerland, facility specializes in drug product manufacturing and packaging, offering flexibility in late-stage clinical and commercial-scale production. We expect to add spray drying capabilities in 2026, followed by parenteral drug manufacturing and lipid nanoparticle (LNP) capabilities. In Asia, we operate from multiple locations. In 2024, we broke ground to build an R&D and manufacturing site in Singapore, which will offer API manufacturing for small molecules, oligonucleotides, peptides and complex chemical conjugates. Phase I operations there are expected to commence in 2027. Greg Slabodkin: Where is WuXi AppTec investing to support future growth? Minzhang Chen: Our strategy is clear: follow the science, follow the customer, and follow the molecule. This is the essence of our integrated CRDMO model, supporting us to stay at the forefront of the industry and create value for our customers. A key focus of our investments is on expanding capabilities related to new modalities. For example, our WuXi TIDES business offers integrated services for oligonucleotides, peptides, and conjugates, including both API and drug product from discovery to commercial stages. In response to rising market demand, particularly in the GLP-1 sector, WuXi TIDES will further expand its overall solid phase peptide synthesizers (SPPS) capacity in China to more than 100,000 liters by the end of 2025, and we plan to add additional capacity at our new facility in Singapore. We have also accelerated capacity construction to meet manufacturing demand for late-stage clinical trial and commercial use. In March 2025, our Changzhou and Taixing API manufacturing sites successfully passed FDA on-site inspections with no single observation. These two sites are critical manufacturing bases for both WuXi STA, our small molecule CDMO, and WuXi TIDES. By the end of 2025, our total reactor volume for small molecule APIs is expected to reach over 4,000k liters. Our Couvet site is boosting capacity to better serve European customers. We have doubled oral dose and tablet production capacity and are adding spray drying capabilities that we expect to be operational in 2026. In the United States, our new manufacturing facility in Delaware is set to launch operations by the end of 2026. A new API facility in Singapore is expected to begin operating in 2027. Greg Slabodkin: What technologies is WuXi AppTec investing in? Minzhang Chen: WuXi TIDES is one of our fastest-growing businesses, offering a full range of CRDMO capabilities from discovery synthesis, process development and manufacturing of novel monomers, linkers and ligands, oligonucleotides, peptides and complex synthetic conjugates at any scale. This streamlined approach enables customers to advance therapies from concept to clinical trials more quickly and cost-effectively. For example, we worked on one complex peptide-PMO conjugates (PPMO) project where we helped our client advance a candidate to Investigational New Drug (IND) filing in just 11 months by having multiple teams work in parallel to optimize synthesis, conjugation, formulation, and analytical methods. We have also invested significantly in TPD compounds. We have partnered with more than 150 companies in this area. We have synthesized more than 188,000 complex TPDs, more than 70 of which have advanced to preclinical candidate (PCC) status and more than 10 of which reached late-stage development. In addition, we also continue to embrace the adoption of green technologies like continuous manufacturing and enzyme technology, which minimize the use of chemicals in our R&D and manufacturing processes to meet fast-growing customer demands.  Greg Slabodkin: Is WuXi STA continuing to expand spray-dried dispersion (SDD) capabilities?  Minzhang Chen: Yes. As a subsidiary of WuXi AppTec, WuXi STA commissioned a new PSD-4 spray dryer at our Taixing API manufacturing facility in July, further increasing our commercial spray drying manufacturing capacity. In May, we broke ground for a new SDD manufacturing building at our Couvet site, with operations expected to begin in 2026. Spray-dried dispersion is a key technology of WuXi STA’s bioavailability enhancement platform, enabling end-to-end solutions from preclinical R&D in tens of milligram scale to commercial manufacturing in metric ton scale.  Greg Slabodkin: How important is sustainability to WuXi AppTec? Minzhang Chen: At WuXi AppTec, everything we do is driven by our commitment to enabling customers to build a healthier world. Like most of our customers, we strategically integrate sustainability priorities into our daily business operations. In recent years, we have increased our investments in sustainability projects such as geothermal energy, solar power, and rainwater recycling at our Couvet and Munich sites. Across our global operations, we are implementing process optimization and promoting green technologies, such as continuous manufacturing and enzyme technology in our R&D and manufacturing processes. Such efforts are aimed at progressively enhancing energy efficiency and reducing carbon emissions within our business operations. We also work with suppliers to reduce absolute greenhouse gas (GHG) emissions associated with purchased goods and services, fostering progress toward a low-carbon supply chain. This year, WuXi AppTec became a Supplier Partner of the Pharmaceutical Supply Chain Initiative (PSCI), joining collective efforts with customers and other industry peers to promote a more sustainable and responsible way of doing business. We are proud that our near-term emissions reduction targets were recently validated by the Science Based Targets initiative (SBTi), and that our sustainability achievements have been acknowledged by major global rating agencies, including MSCI, EcoVadis, CDP and the United Nations Global Compact (UNGC). 免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。 版权说明：欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。 分享，点赞，在看，聚焦全球生物医药健康创新

iStock, ratthanan Under PreCheck, the FDA will communicate more frequently with pharmaceutical companies, helping them as they establish or expand manufacturing sites in the U.S. The FDA on Thursday launched a new program called PreCheck, in hopes of streamlining the regulatory process for pharma companies ramping up their manufacturing infrastructure in the U.S. In a prepared statement on Thursday, FDA Commissioner Marty Makary flagged the country’s “overreliance” on overseas drug manufacturing, which he said has “created national security risks.” PreCheck, in this context, will “help reverse America’s reliance on foreign drug manufacturing,” ensuring a “resilient, strong, and domestic drug supply.” The program operates in two phases. The first, called the Facility Readiness Phase, will allow companies to more frequently communicatewith the FDA “at critical development stages,” as the Thursday announcement put it, such as facility design, construction and pre-production. This stage will also include the use of Drug Master Files , a facility-specific document through which companies provide comprehensive information, including site layout and operations. The second phase will focus on streamlining the Chemistry, Manufacturing and Controls section of the companies’ application. The FDA will make itself available for pre-application meetings and provide applicants with early feedback. FDA’s PreCheck program comes as the U.S. is feeling the effects of President Donald Trump’s tariffs. Sector-specific levies on pharma have yet to be enforced, though the president continues to keep it top-of-mind for the industry. Earlier this week, for instance, he upped the ante by telling CNBC that pharma imports could be subject to duties as high as 250%—the highest rate he’s threatened so far. In early July, he said that tariffs could reach 200% . Last week, Trump reached a trade deal with the EU that, among other things, would slap a 15% tariff on pharma products from the region. There is additionally an ongoing Section 232 national security probe on pharma imports. The investigation remains active, as per a U.S. Department of Commerce webpage . Looking to mitigate the financial impacts of these tariffs, many of the biggest pharma players have pumped billions of dollars into the U.S. to beef up their domestic supply chains. Johnson & Johnson has so far had the biggest commitment with a $55 billion package in March , followed by Roche and AstraZeneca , which have each pledged $50 billion. Generic drugmakers are also joining the U.S. manufacturing blitz. Last week, South Korea’s Celltrion announced that it would pay more than $500 billion to acquire a facility in the U.S., according to reporting from Reuters . Similarly, India’s Aurobindo has bought U.S.-based Lannett for $250 million .

Purdue University, in collaboration with Eli Lilly and Company and Merck & Co. Inc., announced the launch of the Young Institute Pharmaceutical Manufacturing Consortium, a collaborative effort to pioneer advances in making medicines. Operating within Purdue’s William D. and Sherry L. Young Institute for Advanced Manufacturing of Pharmaceuticals, consortium partners will revolutionize pharmaceutical manufacturing with a focus on sterile injectables and innovative aseptic manufacturing technology to ensure quality, safety and compliance. Pharmaceutical manufacturing is a key component of Purdue’s One Health initiative, which advances knowledge and innovation related to animal, human and environmental health and well-being through novel interdisciplinary research and industry partnerships. “We’re on the frontier of Pharma 4.0 — autonomous experimentation, advanced robotics, big data, smart factories, AI and machine learning,” said Karen Plaut, Purdue’s executive vice president for research. “Through this partnership, we will have a global impact in solving complex problems in the pharmaceutical and biopharmaceutical manufacturing ecosystem.” The consortium will elevate and enhance pharmaceutical and biopharmaceutical advanced manufacturing by developing disruptive innovative technologies, autonomous systems, and smart AI and digital technology, together with industrially relevant education and training for the next generation of scientific leaders and researchers. The collaboration also underscores a commitment to onshoring pharmaceutical manufacturing while bolstering domestic production. “Addressing pharma manufacturing challenges requires a significant advancement in technology. With an alliance of this caliber, the consortium will explore greater emphasis on both current and future advanced chemistries and accelerate research of innovative discoveries,” said Elizabeth Topp, director of the Young Institute. Topp, who will serve as the new consortium’s director, is a professor in the Department of Industrial and Molecular Pharmaceutics and the Davidson School of Chemical Engineering and is an expert in improving the shelf life and stability of pharmaceuticals. The consortium will rely on the distinctive research strengths of Purdue, Lilly and Merck, leveraging the organizations’ collaborative research relationship and workforce development programs. The members anticipate the consortium will attract broad participation throughout the sector from other pharmaceutical companies, pharma contract manufacturers, equipment manufacturers, startups and venture capital firms, and will result in a broad base of stakeholders to chart the industry’s future course. The consortium will look to create systems equipped with automated visual inspection and in-line process and product quality monitoring, all of which will require a new generation of skilled pharmaceutical manufacturing engineers and scientists. Through research excellence and comprehensive training opportunities, this program is poised to continue strengthening the pharmaceutical sciences program and preparing talent to support the growth of the sector. “Being a founding member of the Young Institute means building on the remarkable legacy of next-generation manufacturing,” said Arup Roy, senior vice president, technical services and manufacturing science at Lilly. “Together, we will transform the industry with advanced aseptic manufacturing technologies, innovative research, and top-notch education and training to bring pharmaceutical sciences into the future with sterile processing standards. Our work honors Bill Young’s visionary spirit to shape the future of manufacturing and make it a core industry competency for a lasting impact on global communities.” Merck Senior Vice President of Manufacturing Dave Maraldo said generative AI, machine learning and quantum computing are the future of the manufacturing process. “If our collaborative research efforts can use smart technology to accelerate the timeline from research to market, we can reduce costs and bring critical and effective therapies to patients with greater speed,” Maraldo said. “Harnessing innovation will help create a safe and sustainable future for the industry, and most importantly, allow us to better serve patients.” In addition to industry, the Young Institute Consortium will be supported by Purdue’s colleges of Engineering, Pharmacy and Science, which will strengthen its ability to establish strategic priorities for training and education, to foster student engagement and to advance expertise in the field.