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ST. LOUIS--(BUSINESS WIRE)--MilliporeSigma, the U.S. and Canada Life Science business of Merck KGaA, Darmstadt, Germany, today announced a $76 million expansion of its ADC manufacturing capabilities and capacity at its Bioconjugation Center of Excellence facility in St. Louis, Missouri. This investment will triple existing capacity and enhance the company’s contract development and manufacturing organization (CDMO) offering, reinforcing its commitment to clients and patients..
圣路易斯--(商业新闻短讯)--德国达姆施塔特默克公司(Merck KGaA)的美国和加拿大生命科学业务MilliporeSigma今天宣布,将斥资7600万美元扩大其ADC制造能力,并在其位于密苏里州圣路易斯的生物缀合卓越中心(Bioconjugation Center of Excellence facility)扩大产能。这项投资将使现有产能增加两倍,并增强公司的合同开发和制造组织(CDMO)服务,加强其对客户和患者的承诺。。
The investment represents a critical step in the company’s ongoing growth journey to partner with new and existing clients as they advance their drug development pipelines. With additional capacity and by scaling utilities and enhancing Process and Analytical Development (PAD) labs, MilliporeSigma will provide industry-leading support for early-stage and commercial bioconjugates.
这项投资代表了该公司在不断发展的过程中迈出的关键一步,随着新客户和现有客户推进其药物开发渠道,该公司将与新客户和现有客户合作。MilliporeSigma将通过增加容量、扩展公用设施和增强过程与分析开发(PAD)实验室,为早期和商业生物缀合物提供业界领先的支持。
The company’s goal is to ensure clients can bring their innovations to market more effectively and with shorter turnaround times..
该公司的目标是确保客户能够更有效地将其创新产品推向市场,并缩短周转时间。。
“We are shaping tomorrow’s cancer care, today. With this investment, we are not just enhancing our capabilities; we are investing in our clients’ success by accelerating innovation and development to ultimately deliver novel therapies to patients more quickly,” said Benjamin Hein, Head of Life Science Services, Life Science business of Merck KGaA, Darmstadt, Germany.
德国达姆施塔特默克公司生命科学业务生命科学服务负责人本杰明·海因(Benjamin Hein)表示:“今天,我们正在塑造明天的癌症护理。通过这项投资,我们不仅提高了我们的能力;我们还通过加速创新和发展,最终更快地为患者提供新疗法,从而为客户的成功进行投资。”。
“ADCs represent a transformative approach to oncology, enabling targeted therapies that minimize damage to healthy tissues. As the market for this novel modality grows and the medical community adopts them as first-line treatments, it may mean that fewer patients need invasive treatments like chemotherapy and radiation that cause significant side effects.”.
“ADC代表了一种变革性的肿瘤学方法,可以实现靶向治疗,最大程度地减少对健康组织的损害。随着这种新型治疗方式的市场增长,医学界将其作为一线治疗方法,这可能意味着更少的患者需要侵入性治疗,如化疗和放疗,会产生明显的副作用。”。
The ADC capacity expansion project will:
ADC扩容项目将:
Upgrade 34,000 square feet to benefit the Process and Analytical Development, Quality Control, Research and Development, Manufacturing, and Logistics departments.
升级34000平方英尺,使工艺和分析开发、质量控制、研发、制造和物流部门受益。
Add new labs, a dedicated manufacturing buffer preparation facility, and a cold storage and a GMP-controlled room temperature (CRT) warehouse that will be located close to the existing facility.
增加新的实验室,一个专用的生产缓冲液制备设施,一个冷库和一个GMP控制的室温(CRT)仓库,该仓库将位于现有设施附近。
Building on its reputation as the first commercially approved ADC CDMO in North America, the Life Science business of Merck KGaA, Darmstadt, Germany, has made significant investments to expand its ADC manufacturing capabilities for clients worldwide. In 2022, the company opened its $65 million, 70,000-square foot facility in Verona, Wisconsin, USA, dedicated to doubling the production of the most highly potent active pharmaceutical ingredients (HPAPIs) used in novel cancer therapies, including ADCs..
。2022年,该公司在美国威斯康星州维罗纳开设了6500万美元、70000平方英尺的工厂,致力于将用于新型癌症治疗(包括ADC)的最高效活性药物成分(HPAPI)的产量翻一番。。
In addition to recent footprint and capacity expansions, the company continues to innovate differentiated technologies and platforms that accelerate the future potential of this novel modality.
除了最近的足迹和容量扩张之外,该公司还继续创新差异化技术和平台,以加速这种新型模式的未来潜力。
In September 2024, the company launched the Mobius® ADC Reactor, the first scalable single-use mixer specifically designed for ADC manufacturing. MilliporeSigma also launched ChetoSensar®, a technology that alleviates ADC solubility challenges, as well as the ADCore portfolio of advanced payload intermediates, which significantly reduce development and manufacturing time by enabling more efficient synthetic pathways for some of the most common payloads used in ADCs, increasing speed-to-market by up to a year..
2024年9月,该公司推出了Mobius®ADC反应器,这是第一个专门为ADC制造而设计的可扩展一次性混合器。MilliporeSigma还推出了ChetoSensar®,这是一种缓解ADC溶解度挑战的技术,以及先进有效载荷中间体的ADCore产品组合,通过为ADC中使用的一些最常见有效载荷提供更高效的合成途径,大大缩短了开发和制造时间,从而将上市速度提高了一年。。
With more than 35 years of CDMO experience in the development and manufacturing of ADCs, HPAPIs, linker/payloads, and mAbs, MilliporeSigma has evolved alongside the bioconjugate market, offering significant expertise in both clinical and commercial manufacturing:
MilliporeSigma在ADC、HPAPI、连接器/有效载荷和单克隆抗体的开发和制造方面拥有超过35年的CDMO经验,与生物共轭市场一起发展,在临床和商业制造方面提供了重要的专业知识:
Clinical services: Supported more than 60 Investigational New Drugs (INDs), representing ~20% of all ADCs entering clinical trials.
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Commercial services: Supported approximately 50% of commercially approved ADCs with bioconjugation or linker/payload services.
商业服务:通过生物缀合或连接器/有效载荷服务支持大约50%的商业批准的ADC。
Integrated services: Leveraged its extensive CDMO experience in viral vector, lipids, LNP, and mRNA manufacturing — from pre-clinical to commercial — helping to accelerate drug development timelines and production with a single, highly experienced partner.
综合服务:利用其在病毒载体,脂质,LNP和mRNA制造(从临床前到商业)方面的广泛CDMO经验,与经验丰富的单一合作伙伴一起加速药物开发时间表和生产。
Cancer is the second leading cause of death worldwide1. ADCs are one of the most promising drug modalities for cancer treatment. Since 2017, there has been a significant increase in approvals for ADCs. This growth is attributed to advancements in linker and conjugation technologies that improve safety and efficacy, as well as the designation of ADCs as first-line therapies.
癌症是全球第二大死亡原因1。ADC是治疗癌症最有前途的药物之一。自2017年以来,ADC的批准数量大幅增加。这种增长归因于接头和缀合技术的进步,这些技术提高了安全性和有效性,以及将ADC指定为一线疗法。
As a result, confidence in this modality has risen, leading to an annual increase of over 30% in the number of molecules in the global ADC pipeline. As the pipeline matures with continuous and accelerated approvals, the ADC therapeutics market is expected to grow at 15% CAGR by 20282, substantiating this modality’s promise as a targeted novel therapy..
因此,对这种方式的信心有所提高,导致全球ADC管道中的分子数量每年增加30%以上。随着管道的不断成熟和加速批准,到20282年,ADC治疗市场预计将以15%的复合年增长率增长,证实了这种方式作为靶向新型疗法的前景。。
The ability of ADCs to reach and target diseased cells without damaging nearby healthy tissues is also demonstrating significant potential beyond oncology, particularly with innovative bioconjugates like Antibody-Oligonucleotide Conjugates (AOCs) and Radioimmunoconjugates. These bioconjugates are being explored for a variety of applications, including autoimmune diseases, infectious diseases, and neurodegenerative disorders.
ADC在不损害附近健康组织的情况下到达和靶向患病细胞的能力也显示出超越肿瘤学的巨大潜力,特别是使用创新的生物缀合物如抗体寡核苷酸缀合物(AOC)和放射免疫缀合物。这些生物缀合物正在探索各种应用,包括自身免疫性疾病,传染病和神经退行性疾病。
This expanding scope highlights the transformative role of bioconjugates in advancing personalized medicine across diverse therapeutic areas..
这种扩大的范围突出了生物缀合物在不同治疗领域推进个性化医学方面的变革作用。。
About the Life Science business of Merck KGaA, Darmstadt, Germany
关于德国达姆施塔特默克公司的生命科学业务
The Life Science business of Merck KGaA, Darmstadt, Germany, which operates as MilliporeSigma in the U.S. and Canada, has more than 27,000 employees and more than 55 total manufacturing and testing sites worldwide, with a portfolio of more than 300,000 products focused on scientific discovery, biomanufacturing and testing services.
德国达姆施塔特默克公司(Merck KGaA)的生命科学业务在美国和加拿大作为MilliporeSigma运营,在全球拥有27000多名员工和55多个总制造和测试站点,拥有300000多种产品,专注于科学发现、生物制造和测试服务。
Merck KGaA, Darmstadt, Germany, a leading science and technology company, operates across healthcare, life science and electronics..
德国达姆施塔特默克公司是一家领先的科技公司,经营医疗保健、生命科学和电子产品。。
Around 63,000 employees work to make a positive difference to millions of people’s lives every day by creating more joyful and sustainable ways to live. From providing products and services that accelerate drug development and manufacturing as well as discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere.
大约63000名员工通过创造更快乐和可持续的生活方式,每天努力为数百万人的生活带来积极的影响。从提供加速药物开发和制造的产品和服务,以及发现治疗最具挑战性疾病的独特方法,到实现设备的智能化,该公司无处不在。
In 2023, Merck KGaA, Darmstadt, Germany, generated sales of € 21 billion in 65 countries..
2023年,德国达姆施塔特默克公司在65个国家的销售额达到210亿欧元。。
The company holds the global rights to the name and trademark “Merck” internationally. The only exceptions are the United States and Canada, where the business sectors of Merck KGaA, Darmstadt, Germany, operate as MilliporeSigma in life science, EMD Serono in healthcare and EMD Electronics in electronics.
该公司在国际上拥有“默克”名称和商标的全球权利。唯一的例外是美国和加拿大,德国达姆施塔特默克公司(Merck KGaA)的业务部门在生命科学领域担任MilliporeSigma,在医疗保健领域担任EMD Serono,在电子领域担任EMD Electronics。
Since its founding in 1668, scientific exploration and responsible entrepreneurship have been key to the company’s technological and scientific advances. To this day, the founding family remains the majority owner of the publicly listed company. For more information about Merck KGaA, Darmstadt, Germany, visit http://www.emdgroup.com.
自1668年成立以来,科学探索和负责任的创业精神一直是该公司技术和科学进步的关键。。有关德国达姆施塔特默克公司的更多信息,请访问http://www.emdgroup.com.
Follow MilliporeSigma on Twitter @MilliporeSigma, on Facebook @MilliporeSigma and on LinkedIn.
关注Twitter@MilliporeSigma、Facebook@MilliporeSigma和LinkedIn上的MilliporeSigma。
All Merck KGaA, Darmstadt, Germany news releases are distributed by email at the same time they become available on the EMD Group website. In case you are a resident of the U.S. or Canada please go to www.emdgroup.com/subscribe to register again for your online subscription of this service as our newly introduced geo-targeting requires new links in the email.
所有默克公司(Merck KGaA)、达姆施塔特(Darmstadt)的新闻稿均通过电子邮件分发,同时可在EMD集团网站上查阅。如果您是美国或加拿大居民,请访问www.emdgroup.com/subscribe再次注册您在线订阅此服务,因为我们新推出的地理定位需要电子邮件中的新链接。
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1 “Global Cancer Facts & Figures 4th Edition, https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/global-cancer-facts-and-figures/global-cancer-facts-and-figures-4th-edition.pdf
1“全球癌症事实与数字第四版,https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/global-cancer-facts-and-figures/global-cancer-facts-and-figures-4th-edition.pdf
2 “Antibody Drug Conjugates (ADC) Market - Global Forecast to 2028,” https://www.marketsandmarkets.com/Market-Reports/antibody-drug-conjugates-market-122857391.html
2“抗体-药物偶联物(ADC)市场-2028年全球预测”https://www.marketsandmarkets.com/Market-Reports/antibody-drug-conjugates-market-122857391.html