媒体声音｜探访瑞士库威基地：CRDMO模式如何加速全球创新转化？

编者按

瑞士，是全球生物医药创新的重要高地。凭借卓越的科研能力与高度国际化的合作环境，这片土地既吸引了大型跨国药企，也培育了众多生物科技新锐。

作为创新赋能者，药明康德已深度融入这一充满活力的生态圈。我们的瑞士库威（Couvet）基地正依托一体化CRDMO业务模式，赋能全球药企加速研发进程。

近期，药明康德高级副总裁，制剂研发和生产业务部负责人陈金玲博士接受了德国媒体VC Magazin专访。作为深耕行业二十余年的资深专家，陈博士深入解读了CRDMO模式的价值，并分享了瑞士库威基地如何构建稳健的能力体系，以高效应对复杂研发挑战。

无论是在欧洲、北美还是亚洲，药明康德正持续赋能全球合作伙伴，加速创新转化，让更多突破性疗法更快惠及患者。

以下是报道节选的编译。点击“阅读原文/Read More”即可访问原文页面。

01

CRDMO模式的独特价值

VC Magazin：在生命科学领域，初创企业往往面临高昂的实验室建设和运营成本。专注于开发和生产的CDMO，以及专注于研究的CRO，通常是其常见的合作伙伴。而药明康德的CRDMO模式集成了两者，这一模式能为客户带来哪些价值？

陈金玲博士：药物开发与生产密不可分。商业化生产的成功与否，在很大程度上取决于前端开发工艺的稳健性。药明康德的CRDMO模式将研究（R）、开发（D）和生产（M）深度整合。这种“一体化”的优势在于，我们在药物发现阶段进行筛选时，就已经充分评估了后续开发的可行性；同样，在开发阶段，我们也前瞻性地纳入了对生产制造的考量。这不仅有助于提高新药注册申报的成功率，也能打磨出稳健的生产工艺，从而实现从研发到生产的平稳过渡与稳定的商业化供应。

归根结底，CRDMO模式通过开发与生产环节的“无缝衔接”，帮助客户显著节约时间、降低成本并有效规避风险。

VC Magazin：与其他服务提供商相比，药明康德的CRDMO模式有何独特之处？为何对中小型公司特别有吸引力？

陈金玲博士：我们的优势在于真正的“一体化”能力，将药物发现、开发和生产整合于同一个平台，能显著减少不同环节间的转移摩擦，同时确保质量始终如一。

行业内常见的是“先有D再补M”或“拼凑式”能力扩展，而我们的能力是伴随业务自然延伸并高度协同形成的。这意味着我们能提供真正“端到端”的服务——覆盖原料药、制剂生产以及分析测试，分子类型从传统小分子延伸到寡核苷酸、多肽及偶联药物等各类新分子。

此外，横跨亚洲、欧洲和北美的全球运营网络，使我们能为全球客户提供高效且高品质的服务。

对于中小型公司而言，我们独特的“一体化”平台显著降低了管理复杂性，节约了时间与成本，使他们能更专注于自身的科学创新。

VC Magazin：在您看来，CRDMO模式为患者带来了什么价值？

陈金玲博士：CRDMO模式的核心价值在于，以高质量标准加速创新药物惠及患者，为他们提供更优质、更及时的治疗选择。这既是CRDMO模式的使命，也契合药明康德“让天下没有难做的药，难治的病”的愿景。

02

赋能欧洲生态，服务全球客户

VC Magazin：作为药明康德全球CRDMO网络中的关键节点，瑞士库威基地主要服务哪些客户？这一选址有何独特优势？

陈金玲博士：库威基地服务的是全球客户群体，不仅面向欧洲，更广泛地覆盖北美、亚洲等世界各地。在这里生产的创新药物，最终也将造福全球患者。

选址欧洲中部，特别是落户瑞士的优势十分显著：这里汇聚了全球生物技术和制药行业的顶尖人才，我们得以组建一支卓越的专业团队。同时，瑞士完善的产业环境，有助于我们维持高标准的质量体系，并配备一流的生产设施，从而为客户持续提供卓越的服务。

VC Magazin：在欧洲布局生产能力，将如何进一步赋能生命科学行业及其整个生态圈的发展？

陈金玲博士：欧洲本身就拥有深厚的创新土壤。卓越的基础研究、完善的基础设施以及活跃的投资环境交汇于此，加速了早期概念向患者疗法的转化。

药明康德在欧洲的生产基地常态化接受监管机构的严格审查。这种高标准的合规记录，为申办方在后期工艺开发、生产和供应方面提供了信心，这无疑是一个显著优势。此外，欧洲优越的地理位置，使得药品在临床和商业化阶段的物流触达都非常便捷，进一步增强了该地区推动全球生命科学生态圈发展的潜力。

03

以稳健能力赋能创新

VC Magazin：在与初创企业的合作中，他们通常反馈的挑战有哪些？药明康德如何协助解决？

陈金玲博士：初创企业普遍面临几类挑战。首先是资源有限，资金与人员规模受限。其次是经验不足，往往缺乏贯穿整个开发链条的实践积累。尽管团队精简，但他们研发项目的复杂性并未因此降低。事实上，许多现代药物分子的结构日益复杂，可能带来人体内的溶解度差、渗透性弱和生物利用度低等难题。

为应对这些挑战，药明康德依托深厚的技术积累和规模化能力，为其提供解决方案。2025年，药明康德为客户成功合成并交付超过42万个新化合物，其中小分子CDMO管线中在研分子超过3400个。丰富的项目经验让我们构建了稳健的能力体系，能够高效应对各类研发挑战。

为有效管理复杂项目，我们持续扩大投入，建能力、扩规模。我们的基地配备了先进的设施、自动化系统以及完善的质量体系，这些都是保障后期商业化生产成功的关键所在。同时，我们还应用前沿技术手段应对大分子与复杂分子的特定挑战。

正是这些持续的投入和全面的能力，让我们能够赋能客户将候选化合物快速推进至临床研究及后续开发阶段。

VC Magazin：在库威基地，药明康德如何保障知识产权和数据隐私，确保客户信息的安全与合规？

陈金玲博士：知识产权（IP）保护是我们运营的基石，更是客户成功的生命线。无论是在库威基地，还是药明康德的全球网络，我们利用多重工具和方法严密守护客户的IP，以此赢得合作伙伴的信赖。从入职第一天起，所有员工都必须接受严格的IP保护培训。我们恪守全球标准，对违规行为采取“零容忍”态度，并在每一个运营基地推行统一的最佳实践，以高度的一致性，筑牢客户信任。

‘We’ve built robust capabilities to tackle a wide range of issues efficiently’

At WuXi AppTec’s Couvet site in Switzerland, an integrated CRDMO approach is being designed to accelerate the path from discovery to commercial manufacturing. Dr Jinling Chen explains how combining research, development, and manufacturing helps life sciences companies bring innovative medicines to patients more swiftly and more reliably.

VC Magazin: Life sciences involve laboratory and organisational costs that a start-up must cover in its early stages. CDMOs, which focus on development and manufacturing, as well as CROs specialising in research, are a strong alternative. In your CRDMO model, you combine both. What exactly does CRDMO deliver?

Chen: Pharmaceutical development and manufacturing are closely related, and the success of manufacturing strongly depends on the robustness of the development process. The CRDMO model integrates research (R), development (D), and manufacturing (M), ensuring that choices made during discovery are informed by development feasibility, and that manufacturing considerations are taken into account during the development phase. This approach helps ensure not only successful filing for approval but also a robust manufacturing process. This leads to a smooth transition to the manufacturing stage and reliable commercial supply of the material. Ultimately, the CRDMO model saves time, reduces costs, and mitigates risks by tightly linking development and manufacturing.

VC Magazin: What differentiates your CRDMO model from other providers, and why is it particularly attractive for smaller companies?

Chen: Our CRDMO stands out because it integrates the entire process from drug discovery, development, and manufacturing into one organisation, helping eliminate handoffs, while ensuring unwavering quality. Unlike other providers that may start with development (D) and then move to manufacturing (M) or vice versa, we have grown these capabilities together organically. This means we can offer comprehensive services, including drug substance production, drug product manufacturing, and analytical testing, for a wide range of products from small molecules to oligo, peptides, and conjugates. Additionally, our global operations span from Asia to Europe and North America, allowing us to provide efficient and high-quality services to our customers and partners worldwide. This all-in-one approach is particularly attractive for smaller companies as it reduces complexity, saves time, and lowers costs.

VC Magazin: Your site in Couvet, Switzerland, plays an important role for your CRDMO platform. Who belongs to your customer base in Switzerland, and what distinguishes this location?

Chen: Our Couvet site serves a global customer base. We have clients from North America, Europe, Asia, and other parts of the world. So, it’s not just European customers; the medicines enabled by us are intended for global use. Having the site in Central Europe, specifically in Switzerland, is advantageous because it allows us to attract top talent in the biotech and pharmaceutical industry. Additionally, the location enables us to maintain high-quality systems and top-notch equipment. This helps us deliver the best quality to our customers.

VC Magazin: What advantages do European manufacturing facilities offer for the life sciences industry and its ecosystem?

Chen: The dedication of Europe’s innovation hubs to accelerate translation of early-stage ideas into patient therapies has been well demonstrated in terms of the excellent basic research, infrastructure, and dynamic investments. Our European manufacturing facilities are routinely inspected by regulatory authorities. These inspections provide sponsors with greater confidence in late-stage process development, manufacturing, and supply, which is a significant advantage. Additionally, Europe’s geographic location allows for easy access to medicines at both clinical and commercial stages, further enhancing its potential in advancing the life sciences industry and its ecosystem.

VC Magazin: What challenges do the start-ups you collaborate with report, and how do you address them?

Chen: Start-ups typically face several challenges. Firstly, there are the limited resources; they often have constrained financial resources and a small team. Secondly, there’s often a lack of experience in all aspects of development. Although the complexity of their projects does not decrease just because the team is small. Many modern molecules have very complex structures, which can lead to issues such as poor solubility, permeability, and low bioavailability in human bodies. To address these challenges, we leverage our extensive expertise and capacity. WuXi AppTec handles more than 420,000 compounds each year with more than 3,400 molecules in our small molecule CDMO pipeline. We’ve built robust capabilities to tackle a wide range of issues efficiently. We’ve also made significant investments in expanding our capabilities and capacities to manage complex projects effectively. Our sites are equipped with state-of-the-art facilities, automated systems, and quality systems, which are crucial for late-stage commercial manufacturing. Additionally, we use advanced technical tools to address specific challenges related to large complex molecules. All these investments and capabilities enable us to help our clients advance their compounds quickly into clinical studies and subsequent stages of development.

VC Magazin: From your perspective, what added value does CRDMO ultimately bring for the end customer – the patient?

Chen: The CRDMO model is about helping innovative medicines reach patients faster while maintaining the highest standards of quality. This means enabling better treatment options for patients. That is central to both the mission of our CRDMO model and the vision of WuXi AppTec: ‘every drug can be made, and every disease can be treated’.

VC Magazin: How does WuXi AppTec handle intellectual property and data privacy at the Couvet site to ensure client confidentiality and regulatory compliance?

Chen: Intellectual property (IP) protection is fundamental to our operations and to our customers’ success. We safeguard customers’ IP using numerous tools and methods, fostering trust with our valued partners – not just at the Couvet site, but across the entire WuXi AppTec network. From day one, all teams are trained on IP protection. We adhere rigorously to global standards, have zero tolerance for non‐compliance, and require that every site employ uniform best practices to ensure consistency and trust.