救回“几乎被放弃”的分子，药明康德喷雾干燥技术与能力的背后 | 专访陈金玲博士

2026年5月，在药明康德位于瑞士的库威基地（Couvet Site），一场别开生面的“开放日”活动正在举行。

在这座位于欧洲腹地的研发生产基地中，来自全球的客户与合作伙伴穿梭于高度自动化的制剂生产产线之间，而对许多人来说，最吸引他们的目光的，是那座高达六层楼、通体银白的巨型设备——PSD-4喷雾干燥设施。

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正参与其中，为来自全球的合作伙伴介绍新落成的喷雾干燥车间，以及即将于今年四季度投产的全新喷雾干燥设备。

故事的开端，往往始于一个看似无解的难题。

几年前，药明康德接手了一个复杂的新药开发项目，该分子的分子量超过1000道尔顿，水溶性低，口服吸收率低于1%，几乎被判定为“不具备继续开发价值”。

这类分子是当下抗癌新药研发领域的前沿方向之一的蛋白降解靶向嵌合体，在靶向“不可成药”的蛋白靶点方面具有多重优势。然而，其高分子量以及复杂的化学结构也为其开发带来了极大的挑战——溶解度差、口服生物利用度低。

当客户找到药明康德，陈金玲博士和她的团队没有轻易放弃。“通过与客户的紧密合作，团队探索了多种提高化合物生物利用度的药物递送方法，最终发现喷雾干燥最为有效。”她回忆道。经过审慎的喷雾干燥和制剂处方筛选、配方优化以及工艺流程调整，团队成功将该化合物的生物利用度提高到30%以上。

30%，这个数字不仅仅是实验室里的一行数据，它意味着一个原本要被束之高阁的化合物，那个原本“几乎被放弃”的分子，重新获得了继续进入临床开发以及走向患者的“入场券”。

因为一项关键技术的赋能，让希望重燃。这个故事，正是药明康德在库威基地持续扩建喷雾干燥能力的生动注脚。“这样的例子还有很多，喷雾干燥技术在解决重大开发难题方面具有巨大潜力。”陈金玲博士语气坚定。

攻坚分子溶解度，一项技术的深耕与进化

喷雾干燥技术并非新鲜事物，它在食品、化工领域早已有广泛应用。但在制药领域，它肩负着特殊的使命：攻坚那些结构越来越复杂、溶解度越来越差的“难开发分子”。

正如陈金玲博士所言：“许多小分子化合物，尤其那些分子量更大、结构更复杂的分子，在药物开发中最常见的挑战之一是溶解度和吸收率低。”随着科学的进步，药物研发的边界被不断推向前沿。过去几十年，相对简单的分子如同“树上低垂的果实”已被摘完，现在科学家们面对的，是那些更高处、更难以触及的目标。

“我们正不断进入前人未曾涉足的领域，去摘取那些更高处的果实。这自然带来了更复杂的分子结构。”陈金玲博士分析道，“随着科学的进步，我们对药物靶点的理解更深入了，有机化学家们也掌握了构建复杂分子的先进工具。一些过去因成本或技术限制而无法实现的想法，如今借助现代科技也变得可行。”

无论是靶向KRAS这类“难以成药”靶点的抗肿瘤药，还是其他具高分子量的复杂分子结构，都预示着新药开发领域正面临一个共同的趋势：分子结构的复杂化。

“分子结构正变得越来越复杂，合成路线更长，官能团更多，这使得化合物的溶解和吸收愈发困难。”陈金玲博士指出，若不解决这个瓶颈，即使分子的靶向性再精准、药理活性再强，如果无法被人体有效吸收，将无法用于口服制剂。

目前，难溶化合物的挑战是全球性的，整个行业都在探索各种创新技术来应对这一趋势。药明康德旗下的合全药业多年来打造了包括喷雾干燥分散、热熔挤出、纳米悬浮、液体胶囊等全方位的工艺技术平台。而喷雾干燥分散技术是经验证极为有效的解决方案之一。

作为全球创新的赋能者，药明康德多年来已逐步构建起完整的喷雾干燥分散技术能力与配套设备，可支持从实验室规模到临床及商业化生产的开发与生产。目前，合全药业已配备各种规模的喷雾干燥设施（如PSD-1、PSD-3和PSD-4），可灵活应对不同阶段分子的需求。

“实验室阶段，我们使用小型喷雾干燥机来评估化合物的特性，并在早期开发阶段支持化合物筛选。随着项目推进，我们会切换至符合GMP标准的设备来生产临床试验用药物。商业化生产阶段，则启用如PSD-4这般大型喷雾干燥设备。”陈金玲博士进一步介绍道。

而且，这种从实验室微量研究到商业化生产的完整配套能力，并非孤立的点，而是一张覆盖全球的网络。“不仅是库威，在泰兴我们也配备了完全相同的PSD-4喷雾干燥设施，实现了从毫克级研发到大规模生产的全覆盖。”这种双基地平台布局，不仅确保了工艺的稳健性和质量的一致性，更构建了稳定可靠的全球供应体系。

在赋能客户的众多案例中，喷雾干燥技术的一体化平台优势被一次次验证。

几年前，合全药业曾参与开发的一款糖尿病药物，团队运用喷雾干燥技术，成功开发出了片剂制剂。该药现已成功上市，惠及了众多患者。截至目前，合全药业喷雾干燥技术平台已支持5款新药成功获批上市。

“无论是助力肿瘤学领域KRAS靶向药或靶向蛋白降解剂开发，还是助力糖尿病领域新药的制剂开发，这些例子都凸显了公司在这些重大疾病领域对客户的坚定支持以及对行业的持续贡献。”陈金玲博士充满自豪。

超越技术的边界：CRDMO的“交响乐”

如果说喷雾干燥等技术是一门独奏乐器，那么药明康德的一体化CRDMO平台，就是一整支交响乐团。

一款抗癌药的开发历程案例可以有力证明这一点。在项目早期临床阶段，客户便将整个项目托付给药明康德旗下的合全药业。这不仅仅是一个喷雾干燥的委托，而是涵盖了从原料药、中间体、固体分散体到制剂的全链条研发与生产，甚至包括了后续的注册、验证及动态核查等复杂环节。

想象一下这个场景：在药明康德的某个基地，刚刚合成出几十克的原料药后，立即运至另一个基地，喷雾干燥团队在收到样品的第一时间启动制程，制备出固体分散体（Spray-Dried Dispersion，SDD）；而首批SDD样品刚刚出炉，第三个基地的制剂团队已做好接力准备——三地多团队高效协同，确保项目流畅推进。

在不到两年半的时间里，该项目顺利完成。很快，客户的这款抗癌药物成功获批上市。

“快”的背后，更深层的价值是“稳”。多个任务在统一的质量体系下平行推进，无缝衔接。一旦某环节需要强化、改进，所有团队都能迅速响应，这种即时的、跨部门的协同，能最大限度避免无效产出的产生，有效控制研发风险。

这些，正是药明康德一体化赋能平台与全球网络的价值和精髓所在。其中，瑞士库威基地作为这一网络中的欧洲枢纽，也扮演着独特而关键的角色。

“作为公司全球网络的重要组成部分，库威基地与各基地及平台紧密协同，为客户创造价值。无论是高效的项目推进、多元化的赋能技术平台，还是全球团队所具备的专业能力与丰富经验，客户都能切实受益。比如在一次合作中，库威与上海外高桥、无锡基地团队紧密合作，短短5个月内完成技术转移及生产等，助力客户顺利递交新药申请（NDA）。”陈金玲博士表示。

在瑞士库威基地，精良设备设施与设计理念之上，更融合了药明康德自身的运营理念与质量标准。“来访客户常将其描述为一座极具未来感、近乎理想化的生产基地。”陈金玲博士感慨，“凭借地处欧洲中心的地理优势，库威基地作为全球网络的一部分，能够为客户带来高质量、高效率、高度一体化的优势和价值。”

在这座充满生命力的平台上，来自客户的每一个被严谨对待的分子，都承载着推动疾病治疗的可能。这正是药明康德“让天下没有难做的药，难治的病”这一愿景在此处最切实的体现。

全球新药研发面临的挑战依然复杂而艰巨，但药明康德已做好准备，迎接挑战，回应客户需求，向更高、更深处探索。这也正是药明康德全球一体化CRDMO平台始终秉持的初心与承诺：让每一个有潜力的分子、每一位满怀期待的客户、每一位等待希望的患者，都不被辜负。

How WuXi AppTec Spray Drying Capabilities Solve the Complex Molecule Solubility Challenge | A Conversation with Dr. Jinling Chen

On May 6, 2026, WuXi AppTec welcomed customers and partners from around the world to its site in Couvet, Switzerland. At this facility in the heart of Europe, guests toured the highly automated drug product manufacturing lines, but the main attraction was a new piece of equipment—the PSD-4 spray drying system.

Dr. Jinling Chen, Senior Vice President and Head of Pharmaceutical Development and Manufacturing at WuXi AppTec, was on-hand to introduce guests to the newly completed spray drying plant. The new PSD-4 system is set to begin operations in the fourth quarter of this year.

To fully appreciate the ongoing investment in the spray drying capabilities at the Couvet site, it’s important to have insight into some history.

A few years ago, WuXi AppTec took on a complex new drug development project involving a molecule with a molecular weight of over 1000 Daltons, poor water solubility, and an oral absorption rate of less than 1%. It was almost written off as "non-viable for development."

Across the industry, such molecules, specifically Proteolysis Targeting Chimeras, represent a frontier in cancer drug R&D, offering significant advantages in targeting proteins once considered "undruggable." However, their high molecular weight and complex chemical structure posed enormous development challenges—poor aqueous solubility and low oral bioavailability.

When the client approached WuXi AppTec, Dr. Chen and her team did not give up easily. "Through close collaboration with the client, the team explored various drug delivery methods to improve the compound's bioavailability, ultimately finding spray drying to be most effective," she recalled.After careful spray drying and formulation screening, optimization, and process optimization, the team successfully increased the compound's bioavailability to over 30%, rendering it viable for further clinical development.

This 30% figure is more than just a data point in a lab. It meant that a compound destined for the shelf — a molecule that had been "nearly abandoned" earned a new ticket to continue into clinical development and, ultimately, to reach patients.

This is just one example of how spray drying can solve significant development challenges. It is a story that vividly underscores WuXi AppTec’s ongoing enhancement of spray drying capabilities. "There are many such examples. Spray drying technology holds immense potential for addressing major development challenges," Dr. Chen stated.

Tackling Molecule Solubility: The In-Depth Evolution of a Technology

Spray drying is not a new concept; it has been widely used in food and chemical industries for decades. In the pharmaceutical sector, it serves a unique purpose: tackling the "hard-to-develop molecules" whose structures are becoming increasingly complex and whose solubility is declining.

As Dr. Chen explained, “For many small molecules, especially those with larger molecular weights and complex structures, one of the most common challenges in pharmaceutical development today is poor aqueous solubility and low oral absorption rates, known as BCS Class II or IV compounds.” With scientific advancements, the boundaries of drug development are constantly being pushed. Over the past few decades, relatively simple molecules—the low-hanging fruit—have already been picked, leaving scientists to focus on tackling more complex molecules.

"We are entering more untouched territories, leading to more complex molecules," Dr. Chen continued, "With advancements in science, we understand more about targets, and organic chemists have better tools to form these complex molecules. Additionally, what was once economically unviable is now possible with modern technology."

Whether it’s anti-tumor drugs targeting “undruggable” KRAS proteins or other complex molecules with high molecular weight, the field of new drug development is facing a common trend: increasing molecular weight and complexity.

"Molecules are becoming more complex, with longer synthetic routes and more functional groups, making them harder to dissolve and absorb," Dr. Chen pointed out. "If this bottleneck is not addressed, even with precise targeting and potent pharmacological activity, molecules cannot be developed into oral formulations if they cannot be effectively absorbed by the human body."

The challenges are the same globally, and the entire industry is exploring innovative technologies to address them.WuXi AppTec’s subsidiary, STA, has spent years building a comprehensive drug delivery technology platform, including Spray Drying (SDD), Hot Melt Extrusion, Nano Particles, and Liquid Capsules. Among these, spray drying has proven to be one of the most effective solutions.

"Spray drying technology has been an essential tool to address these challenges.” Dr. Chen remarked.

As a global enabler of innovation, WuXi AppTec has, over the years, built a complete set of spray drying and supporting equipment, enabling development and manufacturing from lab scale to clinical and commercial production. Currently, STA possesses different types of spray drying systems (such as PSD-1, PSD-3, and PSD-4), offering the flexibility to meet the needs of molecules at different stages.

“In the lab, we use small-scale spray dryers to evaluate compound properties and support formulation selection during the early development stages. As the compound progresses, we scale up to GMP-compliant spray dryers to produce clinical trial materials. For commercial production, we use large-scale spray dryers like the PSD-4, which is a six-story tall piece of equipment,” Dr. Chen further explained.

Furthermore, this complete capability—from small-scale production to commercial manufacturing—is enhanced by a broad, global network. “Not only in Couvet, but also our site in Taixing, is equipped with identical PSD-4 equipment.” This dual-site strategy ensures process robustness, quality consistency, a stable and reliable global supply network.

The advantages of this integrated spray drying technology platform have been repeatedly validated in numerous customer projects.

A few years ago, Dr. Chen’s team was involved in the development of a diabetes drug for a client. Using spray drying, the team successfully developed a tablet formulation that is now available in the market, benefiting many patients. To date, STA's spray drying platform has facilitated the successful approval and launch of five commercial new drugs.

“Whether assisting in the development of KRAS-targeted drugs in oncology or aiding the formulation development of new diabetes drugs, these examples highlight our firm support for clients in these critical disease areas and our ongoing contribution to the industry,” Dr. Chen said.

Beyond Technical Boundaries: The Symphony of the CRDMO Platform

If technologies like spray drying are akin to playing a solo instrument, then WuXi AppTec’s integrated CRDMO (Contract Research, Development, and Manufacturing Organization) platform represents a full symphony orchestra.

A case study in the development of an anti-cancer drug clearly illustrates this point. In the early clinical stages, the client entrusted the entire program to STA. This wasn’t merely a spray drying contract; it encompassed the full spectrum of development and manufacturing, from the active pharmaceutical ingredient (API), intermediates, and solid dispersions to the final drug product, including the subsequent stages of registration, validation, and regulatory inspection.

Imagine this scenario: At one of WuXi AppTec’s sites, after synthesizing just a few grams of the API, it was immediately transported to another site where the spray drying team started working on the process, preparing solid dispersions. Meanwhile, as the first batch of SDD samples was ready, the formulation team at a third site was prepared to take over — multiple teams across three locations working efficiently in parallel to ensure the project progressed smoothly.

In less than two and a half years, the CMC development and clinical studies were successfully completed. Soon after, the client’s anti-cancer drug was approved and launched.

Behind the speed, the deeper value lies in robustness. Multiple tasks progress simultaneously within a unified quality system, seamlessly connected. Whenever a process step needs improvement, all teams can quickly respond, ensuring real-time cross-department collaboration. This kind of seamless, cross-departmental collaboration minimizes the risk of ineffective output and effectively controls development risks.

This exemplifies the value and essence of WuXi AppTec’s integrated CRDMO enabling platform and its global network. Within this network, the Couvet site in Switzerland plays a unique and crucial role as the European hub.

"As an integrated part of our organization, the Couvet site, along with our facilities globally, provides significant value to our customers. They benefit from our speed, diversified enabling technologies, and the expertise and capabilities of our team around the world. As an example, teams in Shanghai, Wuxi City, and Couvet collaborated closely, rapidly aligning the tech transfer from China to Couvet and advanced the project to NDA submission in just 5 months." Dr. Chen explained.

At the Couvet site, advanced equipment and design concepts are complemented by WuXi AppTec’s operational philosophy and quality standards. "Clients who visit often describe it as a futuristic, dream facility for pharmaceutical manufacturing," Dr. Chen reflected. Leveraging its central European location, the Couvet site, as part of the global network, brings clients the advantages and value of high quality, high efficiency, and high reliability.

Every molecule that is handled with meticulous care holds the potential to advance disease treatment. And while the challenges of global new drug development remain complex, WuXi AppTec is prepared to address the challenge to fulfill the vision that "Every drug can be made, and every disease can be treated."

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