陈珂博士：以“三倍速度”，赢取“十分信任” | 逐梦者说 | Bilingual

编者按：“让天下没有难做的药，难治的病”，是初心，更是愿景。二十五年来，药明康德步履不停：从一间实验室，到覆盖亚洲、欧洲和北美的全球网络。从早期的化学合成服务，到贯穿研究（R）、开发（D）和生产（M）的一体化平台。从第一位客户，到全球三十多个国家的数千合作伙伴。不断发展的，是规模与能力；始终坚守的，是梦想与承诺。

致敬来时路，共谱新篇章！在二十五周年之际，我们以“逐梦者”视角，回顾药明康德成长发展的峥嵘岁月，回望赋能客户创新的并肩往事，更以独特的“药明精神”展望未来新篇章。

接到这项紧急任务的时候，客户只留给陈珂博士的团队四个月的时间。

一切始于一场意外。客户一款正在申报上市的新药，突然接到了欧洲药品管理局（EMA）的挑战，认为注册的起始物料出现了问题。

解决路径看似清晰——必须在四个月内完成补充实验、方法验证和比较研究等全流程工作。然而，挑战在于，客户原先的供应商无力提供额外的支持。

这不仅意味着数百万剂库存药品将无法进入市场，整个商业化进程也可能因此停摆。更令人揪心的是，很多急需用药的患者刚刚燃起的希望，又将陷入未知。

面对燃眉之急，客户找到了药明康德寻求协助。面对缺少资料的原始技术包，接到这项任务的陈珂博士团队一边补全实验方案，一边搭建分析方法，同时无缝衔接研发、供应链与工厂，完成了上百项质量研究与工艺验证，为客户更新了申报所需的所有数据。最终，这款新药有惊无险地获批上市，来到了病患身边。

而这一切，仅仅用了三个月——比原定时间再提前一个月，给客户带来了意外之喜。

回忆起这次往事，如今已担任药明康德旗下合全药业小分子原料药后期和商业化项目负责人的陈珂博士认为，这只是药明康德25年来赋能全球客户的众多案例之一：“为客户突破CMC环节的瓶颈、让药物早日抵达患者，既是我们日复一日的实践，更是团队始终坚持的目标。”

图片来源：123RF

相比“惊喜”，更喜欢“稳健”

“我们始终致力于在所有项目上，不仅符合，更要超越客户的期望值。每一个项目我们都全力以赴，而事实也证明，我们的大部分项目都做到了。”在陈珂博士看来，这种“满满的诚意”，是团队能够超越客户期待、甚至带来惊喜的关键所在。

然而，相比于为客户创造“惊喜”，陈珂博士在自己所负责的后期CMC工作中，则更钟爱另一个词：“稳健”。

在药物从开发迈向商业化生产的关键阶段，质量的稳健性至关重要。它源于后期开发“不容有失”的现实：当进入工艺验证阶段，监管机构对每一步都有着极为严格的标准。

“药物分子生产过程中，即便只有其中一步略微偏离标准，哪怕对最终质量没有实质影响，整个验证批次也会被判定为失败。”陈珂博士强调。一旦失败，客户的上市申报进程可能延迟一年甚至更久。

“真正理想的项目，是所有数据都在预期范围之内。每一个工艺参数、每一次纯度波动、每一批产率变化，都反映着团队系统性知识的成熟度。”陈珂博士指出，“在后期CMC中，并非产出越高越好，超出规范标准之外的产量，反而可能预示着对某些环节的认知尚未到位。”

对稳健性的高度追求，不仅帮助团队在速度与质量之间找到长期平衡，也持续增强了体系的可复制性和可验证性。正是这个“稳”字，确保了药明康德高质量项目的持续产出，助力客户打通药物研发的关键一环，实现从开发（D）到商业化生产（M）的顺利过渡。

后期项目的这种质量稳定性，也是药明康德坚守全球高标准的重要组成部分。二十五年来，药明康德已建立起一个“经得起随时随地检验”的全球质量体系。自2009年起，药明康德化学业务平台已成功通过全球监管机构审计超过140次。今年3月，合全药业常州和泰兴基地更以“零缺陷”通过了美国FDA检查。

“不需要再继续验证了”

不过，并非所有客户从一开始就能理解药明康德的高质量体系。

数年前，陈珂博士团队承接了一个特别的项目：某家合作伙伴正计划从一家生物科技公司引进一款颇具前景的药物，并希望委托给药明康德负责生产。

“我们当时做了一个常规的服务包，从时间规划上并没有刻意追求速度。”陈珂博士回忆道。然而，当那家生物技术公司看到项目时间表后，第一反应却是质疑——“这不可能实现”。

对方直言：“你们的速度是原先供应商的三倍，要么质量肯定不过关，要么肯定有其他什么‘猫腻’。”这让陈珂博士颇有点哭笑不得。

她没有多做辩解，而是选择用事实回应——项目团队迅速生产了一批样品，自信地交给对方检测。

这款分子的合成一共需要十步反应。团队每完成一步，就将合成的中间体送往对方指定的独立实验室进行检测与放行。确认无误后，团队再进行下一步的操作。

还没等验证完全部的步骤，这家生物技术公司便发来邮件：“不需要再继续验证了，我们立即启动项目。”

后来，这款药物的所有权几经变更，但分子的后续合成，始终交由药明康德团队负责，成为一份跨越时间与变局的信任。

“因为我们有真正的一体化平台”

在药明康德的CRDMO平台上，陈珂博士负责推动客户小分子项目从开发到商业化生产的关键阶段。这意味着，一款新药分子迈入后期开发，全力冲刺上市目标。

“加速”，已成为全球新药研发的主旋律。而药明康德，则以高效整合的一体化平台，为客户提供加速的推动力。

陈珂博士分享了另外一个案例：一款抗癌药在早期临床阶段就在合全药业的平台上进行开发，涵盖原料药、中间体、固体分散体、制剂的研发和生产，以及注册、验证以及动态核查等多个复杂的环节。

在一体化平台的支持下，多个任务在统一的质量体系下平行推进，无缝衔接。一个基地负责原料药，另一个基地承担喷雾干燥制备固体分散体，第三个基地负责制剂——三地团队高效协同，确保项目流畅推进。

“比如原料药生产出几十克后，立即交给喷雾干燥团队同步启动；喷雾干燥做出首批样品，马上交给制剂去接力，”陈珂博士解释道。

“这种模式不仅显著提速，更在各环节中有效控制风险，一旦某环节需要强化、改进，所有团队都能迅速响应，最大限度避免无效产物的产出。“她进一步解释。

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。

图片来源：123RF

“如果将这些生产环节分散给不同的供应商，整个过程可能需要三年多，甚至四年以上。”陈珂博士说，客户后来也多次公开表达感谢，坦言“如果没有药明康德，这款药物不可能这么快上市。”

“如果要说我们哪里做的不一样，那就是我们有真正的一体化平台。”陈珂博士总结道。

正是这样的整合实力，使药明康德有能力为客户解决难题，突破挑战。

“即便是技术壁垒高、时间紧迫、或面临CMC挑战的项目，合全药业同样能够做得非常扎实。”陈珂博士笃定地说道。

不忘初心，行稳致远

陈珂博士清晰地记得，2018年初入公司时，药明康德常州基地还只有一期。如今，常州基地三期已经投入运营。放眼全球，药明康德已拥有包括二十多个研发生产基地的全球运营网络，持续为全球医药创新赋能——从泰兴、无锡、到上海金山等多个基地稳步推进产能建设；在欧洲，瑞士库威基地专注于制剂商业化生产和包装，并正在建设喷雾干燥等新能力；同时，新加坡基地、美国特拉华州米德尔顿基地等建设也正在稳步推进中。

多年来，陈珂博士见证了公司产能与规模的不断跨越，也深深认同药明康德始终坚守的愿景：“让天下没有难做的药，难治的病”。

在行业深耕十余载，陈珂博士也始终怀揣着一份不曾改变的初心。

“不忘初心，行稳致远，坚持长期主义。把每一个项目做好，将更多新药推向市场。”

采访尾声，陈珂博士这样总结。这不仅是个人信念，也映照了药明康德二十五年来持续为客户、行业和病患创造价值的坚实足迹。

Bridging the D-to-M Transition

Editor’s Note: “Every drug can be made and every disease can be treated”. Over the past 25 years, from a single laboratory to a global network spanning Asia, Europe, and North America; from early chemical synthesis services to an integrated platform that connects Research (R), Development (D), and Manufacturing (M); from its very first customer to thousands of partners across more than 30 countries, WuXi AppTec has never stopped moving forward to realize its enduring vision.

In tribute to the journey and in celebration of new beginnings, we look back through the eyes of our “dream-makers”: revisiting the stories of partnership that empowered global innovation, and the unique spirit that continues to guide us toward the next chapter.

An email arrived in Dr. Ke Chen’s inbox. The head of API Late Phase Development and Commercialization at WuXi STA, a subsidiary of WuXi AppTec, opened it and began reading. She was expecting a routine update. Instead, the message took her by surprise.

A partner, in negotiations to license a promising drug from a biotech company, had requested WuXi STA to handle the manufacturing. Chen’s team had prepared a proposal outlining the expected production timeline. It was a traditional estimate, not even an aggressive one by their internal standards.

Then came the reply: the biotech company refused to move forward.

“Your timeline is nearly three times faster than our current vendor. That’s impossible,” its leadership wrote. “Either the quality will suffer, or you’re exaggerating.”

Rather than defending their credibility with words, Chen and her team turned to scientific demonstration. They proposed a bold experiment: a demonstration batch produced step-by-step under full oversight. Each of the 10 synthetic stages would be paused for the partner’s testing before the next stage began, a gesture of transparency and confidence.

Mid-experiment, the biotech company was convinced: “Let’s move on,” they said. WuXi STA completed the program at the proposed pace, met all specifications, and ultimately saved the client time without compromising quality.

The rights of that drug, now FDA-approved, have since passed through several owners and WuXi STA has remained the trusted drug substance (DS)-to-drug product (DP) integrated supplier.

As Dr. Ke Chen recalled, this was just one of many cases where WuXi AppTec has enabled global clients over the past 25 years."Breaking through CMC bottlenecks for our clients and getting medicines to patients faster—this is not only our day-to-day practice but also the unwavering goal of our team,"she said.

Bridging the D-to-M Transition

In the lifecycle of a drug, few moments are as pivotal, and as rigorous, as the handoff from development (D) to manufacturing (M). When a molecule achieves clinical proof of concept (often in Phase 2 trials), it shifts from scientific exploration to commercial execution, where discovery dreams meet the realities of scale, regulation, and business survival.

“As the D-to-M transition sets the foundation for long-term commercial success, the choice of a manufacturing partner is a strategic decision with multi-year implications,” Chen explains. “The partnership must be built on a foundation of reliability and robustness from the very beginning.”

The core of this rigor is manufacturing validation. Every batch that enters the “M” phase must meet rigorous standards of reproducibility, documentation, and data integrity under the scrutiny of regulators such as the FDA, EMA, and NMPA.

“In a well-executed project, all process data should fall within the expected range.” Chen explained. She further emphasized that a single out-of-specification (OOS) result, even one with no impact on final product quality, can invalidate an entire validation campaign, delaying submission for a year or more, disrupting launch timelines, and postponing patient access to needed therapy.

This is why, as Chen describes,“Quality in late-stage manufacturing is a lifeline.”It demands not only technical expertise but also deep regulatory insight, necessitating a partner proficient in both domains.

WuXi STA has built precisely that record. The team has supported more than 50 first-time, global NDA approvals while maintaining a zero-delay record for CMC filings. Through first three quarters of 2025 alone, the company has enabled eight successful NDAs, with 10 to 11 expected by year-end. Behind those numbers lies deep scientific capability to help clients tackle some of the industry’s most complex small molecules.

To Chen,the consistent quality in late-stage projects is a vital part of WuXi AppTec's commitment to upholding global high standards.Over the past 25 years, WuXi AppTec has established a global quality system that "stands up to inspection anytime, anywhere."

When the Clock Started Ticking

Several years ago, a multinational pharma company had just acquired a therapy whose registered starting material was abruptly challenged by the EMA during review. The situation was critical: the original European CDMO that produced the material couldn’t help.

The EMA’s notice was clear. Within four months, the company had to revalidate the starting material, provide extensive supplementary documentation, and complete a comparability study, or risk rejection of the application altogether. Without approval, the commercial inventory would be stranded and unable to reach patients in urgent need of the drug.

Within hours of receiving the task, Chen and her team mobilized. A 50-person R&D task force was assembled overnight, soon joined by sourcing specialists, analytical scientists, and manufacturing engineers. The technical package they inherited was incomplete, riddled with gaps and inconsistencies. With the EMA clock running and commercial inventory at risk of sitting idle, the team reframed the problem around a single question: how do we prevent patients from waiting longer?

“Failure wasn’t an option,” she recalls.

Working against the clock, WuXi STA reconstructed the chemical process, developed new analytical methods, and produced multiple validation batches. Every result was documented, reviewed, and assembled into a submission-ready package.In just three months, a full month ahead of EMA’s deadline—the company delivered all data required for regulatory review.The client’s comparability tests passed successfully, and the therapy received EMA approval without any delay in market availability.

To outsiders, it appeared a dramatic rescue. To Chen, the experience was less about miracles than about coordination. It revealed how deeply interconnected R&D, manufacturing, and quality functions must be to solve complex challenges at speed, and how an integrated platform can quietly stabilize a demanding situation while keeping innovation on schedule.

The Power of True Integration

The distinction of WuXi STA’s integrated platform lies not in owning multiple sites, but in operating under one global quality system and a unified management mindset: one project, one continuous chain of accountability.

Several years ago, a client developing a cancer treatment chose WuXi STA to take over manufacturing during its early stage clinical trials. In under two and a half years, WuXi STA used its fully connected network to complete every step needed for testing and approval across four sites, covering everything from making the drug substance to developing and producing the tablets.

Had the client divided production steps among separate vendors, each stage would have required independent release testing and material transfer, a process easily extending to four years. Instead, WuXi STA’s teams ran tasks in parallel, passing materials seamlessly between sites. “It wasn’t just about speed,” Chen notes. “It also enhanced safety by ensuring consistent quality control throughout the molecule's journey.”

This ability to compress timelines without compromising quality has become the engine of WuXi STA’s global credibility.

“The key differentiator is our truly integrated platform,” Chen concluded. It is this integration that enables WuXi STA to tackle clients’ most complex challenges. “Even for projects with significant technical barriers, tight timelines or demanding CMC challenges, WuXi STA consistently delivers robust and reliable outcomes.”

Vision and the Road Ahead

After 15 years in the industry, Chen’s guiding principle has never wavered: remove bottlenecks from CMC.

“Whether it’s chemistry, analytics, or supply chain,our job is to take CMC off the bottleneck,” she says. “To make sure nothing slows a good drug from reaching patients.”

She pauses, then adds a phrase that could serve as both personal mantra and corporate creed:

“Stay true to our purpose. Move steadily. Bring more medicines to life.”

These closing words encapsulate not only her deeply held belief but also the enduring commitment that has characterized WuXi AppTec's 25-year journey: the consistent creation of value for clients, the industry, and patients worldwide.

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。

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