從“這不可能”中破局：藥明康德以“三倍速度”贏得客戶長期信任 | Bilingual

信任，是彌足珍貴的資產。而信任并非一蹴而就，它是在一次又一次高效、高質量的項目交付中，點滴積累、不斷沉淀而成。在藥明康德，這正是團隊與客戶彼此成就的日常。

數年前，藥明康德子公司合全藥業接到一個富有挑戰性的項目：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，并希望委托給合全藥業負責生產。

該分子工藝復雜、單步耗時近20天，副反應多，收率波動明顯。面對這些難題，合全藥業團隊基于一系列系統性分析和工藝優化，僅用2個月就攻克了技術難點，順利完成了工藝轉移與確認。

然而，當項目時間表擺在那家生物科技公司面前時，對方的反應卻出乎意料：

“這不可能實現。”對方直言，“你們的速度是原先供應商的三倍。要么質量不過關，要么其中有什么‘貓膩’。”

面對質疑，項目團隊沒有多做辯解，而是選擇用事實回應。

他們迅速生產了一批樣品，交給對方檢測。這款分子的合成一共需要十步反應，每完成一步，團隊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，再進行下一步。

圖片來源：123RF

對方的認可來得比預期更快。驗證尚未全部完成，團隊便收到了這家生物科技公司的回復：“不需要繼續驗證了，項目立即啟動。”

從那一刻起，質疑轉化為信任，項目也開始全面推進。

一體化平臺能力，助力攻克數個關鍵挑戰

一年多后，該項目進入驗證生產階段。在藥明康德一體化CRDMO平臺的高效協同之下，項目團隊與客戶緊密協作，制定了切實可行的項目計劃，并提前做好風險預判。面對時間緊、需求多變等挑戰，團隊順利攻克了多個技術難關，推動項目穩步前行。

在工藝研發方面，原工藝中某個中間體存在溶劑殘留難以烘干的難題，團隊憑借豐富的生產經驗及工藝工程平臺，通過一系列優化操作，使溶殘一次性達到合格標準——后續生產無需再經過原本繁瑣的烘料循環，效率顯著提升。

在分析方面，團隊充分尊重客戶對原有分析方法的堅持，同時嚴格遵守不同地區的申報法規要求。依托公司一體化分析平臺，團隊高效完成了50余項方法驗證與確認、約30項對照品與雜質的標化及結構確證，以及10余項穩定性及影響因素研究，為項目推進提供了有力保障。

最終，在研發、生產、分析等各團隊的通力合作下，合全藥業團隊僅用7個月，就以“零偏差”的質量穩定性，完成了工藝性能確認（PPQ）批次的生產與交付。

當項目進入NDA申報的關鍵節點，新的考驗隨之而來。申報團隊遇到了預期之中的發補問題。由于項目以另一地區的申報資料作為主體開展本地申報，而不同國家和地區的申報標準存在差異，推進過程中出現了十多項需補充和修改的材料，涉及生產工藝、分析方法等方面。按照常規流程，這類工作需耗時5個月之久。由于發補的完成周期直接決定著上市日期，其推進速度自然成為客戶尤其關切的問題。

依托公司一體化平臺與團隊豐富的經驗，項目團隊通過緊密的客戶溝通，以及工藝研發、分析團隊的通力協作，確保項目的高效推進。最終，團隊僅用2個月就完成了雜質制備、清除研究、分析方法的開發和驗證，以及批次分析等工作，確保了申報如期推進。

這種在關鍵時刻可靠執行、快速解決問題的能力，給客戶留下了深刻的印象，客戶感嘆：“或許只有藥明康德才能完成這種工作。”

圖片來源：123RF

每一次信任，都是新的起點

后來，這款藥物的所有權幾經變更，但無論歸屬如何變化，有一個選擇卻從未動搖：該藥物的后續生產，始終交由藥明康德團隊負責。

這段始于質疑的合作，最終轉變成為跨越時間與變局的信任。

這份信任從來不是偶然。多年來，每一個環節的扎實落地，每一次問題的快速響應，背后都是藥明康德一體化平臺的能力與團隊的智慧。正是這種緊密協作、價值共創的方式，讓一次次交付不僅兌現了承諾，更贏得了長期并肩的默契。

而這樣的案例，并非孤例。它們是藥明康德團隊在一次次攻堅中，反復打磨、沉淀下來的技術和能力的縮影。二十多年來，公司憑借高效、高質量的交付，持續將眾多新客戶轉化為長期合作伙伴，并把每一次信任都視作新的起點。依托于一體化、端到端的CRDMO平臺，藥明康德將繼續賦能全球客戶，將科學創新更快、更穩地轉化為造福患者的療法。

From “Impossible” to “No Verification Needed”: How WuXi AppTec Earns Client Trust

Trust isn’t built in a day. It grows slowly, project by project, with consistent quality and efficiency. At WuXi AppTec, this is what everyday collaboration looks like: teams and clients achieving more together.

Several years ago, a client that was in negotiations to license a promising drug from a biotech company requested WuXi STA, a subsidiary of WuXi AppTec, to handle the manufacturing.

The synthesis of this molecule posed challenges: a single reaction step took nearly 20 days, the process was prone to side reactions, and yields fluctuated. In just two months, the WuXi STA team resolved the technical difficulties in the synthetic route through systematic analysis and process optimization, successfully completing technology mobilization and process qualification.

When the project timeline was presented, however, the biotech company’s reaction was not what anyone expected.

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

Rather than defending their credibility with words, the project team turned to scientific demonstration.

They quickly produced a batch of samples for verification. The synthesis involved 10 reaction steps in total. After each step, the intermediate was sent to an independent lab designated by the biotech company for testing and release before the next step proceeded.

Image source: 123RF

The biotech company’s approval came sooner than expected.Well before the end of the experiment, the biotech company was convinced: “No need for further verification. Let’s move on,” they said.

From then on, doubt gave way to trust, and the project moved forward.

Leveraging Integrated Platform Capabilities to Overcome Key Challenges

A year later, the project had progressed to Process Performance Qualification (PPQ) manufacturing. Leveraging the integrated CRDMO platform, the project team partnered closely with the client to formulate a feasible plan and proactively identify potential risks. Despite tight deadlines and diverse requirements, they overcame multiple technical hurdles and made steady progress.

During process development, a key challenge was drying an intermediate to remove residual solvents in the original process.Leveraging their manufacturing experience and process platform, the team introduced a series of optimizations that brought residual solvents within specifications in a single drying pass—eliminating the need for the previously time-consuming drying cycles and significantly improving efficiency.

In analytical development, the team respected the client's dedication to their original analytical methods while strictly following the regulatory requirements of different regions. Leveraging the company's integrated analytical platform, they efficiently carried out over 50 method validations and verifications, standardized and structurally confirmed around 30 reference standards and impurities, and performed more than 10 stability and forced degradation studies. This comprehensive work provided solid support for advancing the project.

In just seven months, the team delivered the PPQ batches with “zero deviation” in quality and stability through close collaboration across process R&D, manufacturing, and analytics.

When the project reached the NDA submission stage, the team received the expected request for supplemental information. Because the project used submission materials based on another region, and regulatory standards vary by jurisdiction, more than a dozen items—mainly concerning manufacturing processes and analytical methods—required supplementation or revision during the review. Normally, that would take five months. But because the turnaround time for supplemental responses directly affected the launch date, the client was concerned about how quickly the team could move.

Leveraging the company’s integrated platform and the project team’s extensive experience, the team ensured efficient project execution through close client communication and seamless collaboration between process development and analytical development teams.They wrapped up impurity synthesis, purge studies, method development and validation, and batch analyses in just two months, on schedule for the submission.

The client was impressed by the team’s reliable execution and fast problem solving at key moments. “WuXi AppTec is one of the few that could have done this job,” they said.

Image source: 123RF

With Each Trust, a Fresh Start

Over the years, ownership of this drug changed several times. Butno matter who owned it, the WuXi AppTec team was always the one they trusted for subsequent development and manufacturing.

The partnership started with doubt, but over time it turned into trust that has lasted through every change.

Trust like this doesn’t happen by accident. Over the years, every step has been executed reliably and every issue has been addressed quickly. Behind it is the strength of WuXi AppTec’s integrated platform and the team’s deep expertise. This kind of close collaboration and shared success has transformed every delivery from a mere promise kept into a long?standing partnership built on trust.

This is not an isolated case. It shows the technical expertise and capabilities that the WuXi AppTec team has built over years of challenging projects. For over twenty years, the company has turned many new clients into long-term partners by delivering on time with quality assurance. They have always treated every moment of trust as a fresh start. With its integrated, end-to-end CRDMO platform, WuXi AppTec will continue to enable clients worldwide to turn scientific innovations into life-saving treatments faster and more reliably.

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