陳珂博士：以“三倍速度”，贏取“十分信任” | 逐夢者說 | Bilingual

編者按：“讓天下沒有難做的藥，難治的病”，是初心，更是愿景。二十五年來，藥明康德步履不停：從一間實驗室，到覆蓋亞洲、歐洲和北美的全球網絡。從早期的化學合成服務，到貫穿研究（R）、開發（D）和生產（M）的一體化平臺。從第一位客戶，到全球三十多個國家的數千合作伙伴。不斷發展的，是規模與能力；始終堅守的，是夢想與承諾。

致敬來時路，共譜新篇章！在二十五周年之際，我們以“逐夢者”視角，回顧藥明康德成長發展的崢嶸歲月，回望賦能客戶創新的并肩往事，更以獨特的“藥明精神”展望未來新篇章。

接到這項緊急任務的時候，客戶只留給陳珂博士的團隊四個月的時間。

一切始于一場意外。客戶一款正在申報上市的新藥，突然接到了歐洲藥品管理局（EMA）的挑戰，認為注冊的起始物料出現了問題。

解決路徑看似清晰——必須在四個月內完成補充實驗、方法驗證和比較研究等全流程工作。然而，挑戰在于，客戶原先的供應商無力提供額外的支持。

這不僅意味著數百萬劑庫存藥品將無法進入市場，整個商業化進程也可能因此停擺。更令人揪心的是，很多急需用藥的患者剛剛燃起的希望，又將陷入未知。

面對燃眉之急，客戶找到了藥明康德尋求協助。面對缺少資料的原始技術包，接到這項任務的陳珂博士團隊一邊補全實驗方案，一邊搭建分析方法，同時無縫銜接研發、供應鏈與工廠，完成了上百項質量研究與工藝驗證，為客戶更新了申報所需的所有數據。最終，這款新藥有驚無險地獲批上市，來到了病患身邊。

而這一切，僅僅用了三個月——比原定時間再提前一個月，給客戶帶來了意外之喜。

回憶起這次往事，如今已擔任藥明康德旗下合全藥業小分子原料藥后期和商業化項目負責人的陳珂博士認為，這只是藥明康德25年來賦能全球客戶的眾多案例之一：“為客戶突破CMC環節的瓶頸、讓藥物早日抵達患者，既是我們日復一日的實踐，更是團隊始終堅持的目標。”

圖片來源：123RF

相比“驚喜”，更喜歡“穩健”

“我們始終致力于在所有項目上，不僅符合，更要超越客戶的期望值。每一個項目我們都全力以赴，而事實也證明，我們的大部分項目都做到了。”在陳珂博士看來，這種“滿滿的誠意”，是團隊能夠超越客戶期待、甚至帶來驚喜的關鍵所在。

然而，相比于為客戶創造“驚喜”，陳珂博士在自己所負責的后期CMC工作中，則更鐘愛另一個詞：“穩健”。

在藥物從開發邁向商業化生產的關鍵階段，質量的穩健性至關重要。它源于后期開發“不容有失”的現實：當進入工藝驗證階段，監管機構對每一步都有著極為嚴格的標準。

“藥物分子生產過程中，即便只有其中一步略微偏離標準，哪怕對最終質量沒有實質影響，整個驗證批次也會被判定為失敗。”陳珂博士強調。一旦失敗，客戶的上市申報進程可能延遲一年甚至更久。

“真正理想的項目，是所有數據都在預期范圍之內。每一個工藝參數、每一次純度波動、每一批產率變化，都反映著團隊系統性知識的成熟度。”陳珂博士指出，“在后期CMC中，并非產出越高越好，超出規范標準之外的產量，反而可能預示著對某些環節的認知尚未到位。”

對穩健性的高度追求，不僅幫助團隊在速度與質量之間找到長期平衡，也持續增強了體系的可復制性和可驗證性。正是這個“穩”字，確保了藥明康德高質量項目的持續產出，助力客戶打通藥物研發的關鍵一環，實現從開發（D）到商業化生產（M）的順利過渡。

后期項目的這種質量穩定性，也是藥明康德堅守全球高標準的重要組成部分。二十五年來，藥明康德已建立起一個“經得起隨時隨地檢驗”的全球質量體系。自2009年起，藥明康德化學業務平臺已成功通過全球監管機構審計超過140次。今年3月，合全藥業常州和泰興基地更以“零缺陷”通過了美國FDA檢查。

“不需要再繼續驗證了”

不過，并非所有客戶從一開始就能理解藥明康德的高質量體系。

數年前，陳珂博士團隊承接了一個特別的項目：某家合作伙伴正計劃從一家生物科技公司引進一款頗具前景的藥物，并希望委托給藥明康德負責生產。

“我們當時做了一個常規的服務包，從時間規劃上并沒有刻意追求速度。”陳珂博士回憶道。然而，當那家生物技術公司看到項目時間表后，第一反應卻是質疑——“這不可能實現”。

對方直言：“你們的速度是原先供應商的三倍，要么質量肯定不過關，要么肯定有其他什么‘貓膩’。”這讓陳珂博士頗有點哭笑不得。

她沒有多做辯解，而是選擇用事實回應——項目團隊迅速生產了一批樣品，自信地交給對方檢測。

這款分子的合成一共需要十步反應。團隊每完成一步，就將合成的中間體送往對方指定的獨立實驗室進行檢測與放行。確認無誤后，團隊再進行下一步的操作。

還沒等驗證完全部的步驟，這家生物技術公司便發來郵件：“不需要再繼續驗證了，我們立即啟動項目。”

后來，這款藥物的所有權幾經變更，但分子的后續合成，始終交由藥明康德團隊負責，成為一份跨越時間與變局的信任。

“因為我們有真正的一體化平臺”

在藥明康德的CRDMO平臺上，陳珂博士負責推動客戶小分子項目從開發到商業化生產的關鍵階段。這意味著，一款新藥分子邁入后期開發，全力沖刺上市目標。

“加速”，已成為全球新藥研發的主旋律。而藥明康德，則以高效整合的一體化平臺，為客戶提供加速的推動力。

陳珂博士分享了另外一個案例：一款抗癌藥在早期臨床階段就在合全藥業的平臺上進行開發，涵蓋原料藥、中間體、固體分散體、制劑的研發和生產，以及注冊、驗證以及動態核查等多個復雜的環節。

在一體化平臺的支持下，多個任務在統一的質量體系下平行推進，無縫銜接。一個基地負責原料藥，另一個基地承擔噴霧干燥制備固體分散體，第三個基地負責制劑——三地團隊高效協同，確保項目流暢推進。

“比如原料藥生產出幾十克后，立即交給噴霧干燥團隊同步啟動；噴霧干燥做出首批樣品，馬上交給制劑去接力，”陳珂博士解釋道。

“這種模式不僅顯著提速，更在各環節中有效控制風險，一旦某環節需要強化、改進，所有團隊都能迅速響應，最大限度避免無效產物的產出。“她進一步解釋。

在不到兩年半的時間里，該項目順利完成。很快，客戶的這款抗癌藥物成功獲批上市。

圖片來源：123RF

“如果將這些生產環節分散給不同的供應商，整個過程可能需要三年多，甚至四年以上。”陳珂博士說，客戶后來也多次公開表達感謝，坦言“如果沒有藥明康德，這款藥物不可能這么快上市。”

“如果要說我們哪里做的不一樣，那就是我們有真正的一體化平臺。”陳珂博士總結道。

正是這樣的整合實力，使藥明康德有能力為客戶解決難題，突破挑戰。

“即便是技術壁壘高、時間緊迫、或面臨CMC挑戰的項目，合全藥業同樣能夠做得非常扎實。”陳珂博士篤定地說道。

不忘初心，行穩致遠

陳珂博士清晰地記得，2018年初入公司時，藥明康德常州基地還只有一期。如今，常州基地三期已經投入運營。放眼全球，藥明康德已擁有包括二十多個研發生產基地的全球運營網絡，持續為全球醫藥創新賦能——從泰興、無錫、到上海金山等多個基地穩步推進產能建設；在歐洲，瑞士庫威基地專注于制劑商業化生產和包裝，并正在建設噴霧干燥等新能力；同時，新加坡基地、美國特拉華州米德爾頓基地等建設也正在穩步推進中。

多年來，陳珂博士見證了公司產能與規模的不斷跨越，也深深認同藥明康德始終堅守的愿景：“讓天下沒有難做的藥，難治的病”。

在行業深耕十余載，陳珂博士也始終懷揣著一份不曾改變的初心。

“不忘初心，行穩致遠，堅持長期主義。把每一個項目做好，將更多新藥推向市場。”

采訪尾聲，陳珂博士這樣總結。這不僅是個人信念，也映照了藥明康德二十五年來持續為客戶、行業和病患創造價值的堅實足跡。

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.

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