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

信任，是彌足珍貴的資產(chǎn)。而信任并非一蹴而就，它是在一次又一次高效、高質(zhì)量的項(xiàng)目交付中，點(diǎn)滴積累、不斷沉淀而成。在藥明康德，這正是團(tuán)隊(duì)與客戶彼此成就的日常。

數(shù)年前，藥明康德子公司合全藥業(yè)接到一個(gè)富有挑戰(zhàn)性的項(xiàng)目：某家合作伙伴正計(jì)劃從一家生物科技公司引進(jìn)一款頗具前景的藥物，并希望委托給合全藥業(yè)負(fù)責(zé)生產(chǎn)。

該分子工藝復(fù)雜、單步耗時(shí)近20天，副反應(yīng)多，收率波動(dòng)明顯。面對(duì)這些難題，合全藥業(yè)團(tuán)隊(duì)基于一系列系統(tǒng)性分析和工藝優(yōu)化，僅用2個(gè)月就攻克了技術(shù)難點(diǎn)，順利完成了工藝轉(zhuǎn)移與確認(rèn)。

然而，當(dāng)項(xiàng)目時(shí)間表擺在那家生物科技公司面前時(shí)，對(duì)方的反應(yīng)卻出乎意料：

“這不可能實(shí)現(xiàn)?！睂?duì)方直言，“你們的速度是原先供應(yīng)商的三倍。要么質(zhì)量不過(guò)關(guān)，要么其中有什么‘貓膩’?！?/p>

面對(duì)質(zhì)疑，項(xiàng)目團(tuán)隊(duì)沒(méi)有多做辯解，而是選擇用事實(shí)回應(yīng)。

他們迅速生產(chǎn)了一批樣品，交給對(duì)方檢測(cè)。這款分子的合成一共需要十步反應(yīng)，每完成一步，團(tuán)隊(duì)就將合成的中間體送往對(duì)方指定的獨(dú)立實(shí)驗(yàn)室進(jìn)行檢測(cè)與放行。確認(rèn)無(wú)誤后，再進(jìn)行下一步。

圖片來(lái)源：123RF

對(duì)方的認(rèn)可來(lái)得比預(yù)期更快。驗(yàn)證尚未全部完成，團(tuán)隊(duì)便收到了這家生物科技公司的回復(fù)：“不需要繼續(xù)驗(yàn)證了，項(xiàng)目立即啟動(dòng)?！?/strong>

從那一刻起，質(zhì)疑轉(zhuǎn)化為信任，項(xiàng)目也開始全面推進(jìn)。

一體化平臺(tái)能力，助力攻克數(shù)個(gè)關(guān)鍵挑戰(zhàn)

一年多后，該項(xiàng)目進(jìn)入驗(yàn)證生產(chǎn)階段。在藥明康德一體化CRDMO平臺(tái)的高效協(xié)同之下，項(xiàng)目團(tuán)隊(duì)與客戶緊密協(xié)作，制定了切實(shí)可行的項(xiàng)目計(jì)劃，并提前做好風(fēng)險(xiǎn)預(yù)判。面對(duì)時(shí)間緊、需求多變等挑戰(zhàn)，團(tuán)隊(duì)順利攻克了多個(gè)技術(shù)難關(guān)，推動(dòng)項(xiàng)目穩(wěn)步前行。

在工藝研發(fā)方面，原工藝中某個(gè)中間體存在溶劑殘留難以烘干的難題，團(tuán)隊(duì)?wèi){借豐富的生產(chǎn)經(jīng)驗(yàn)及工藝工程平臺(tái)，通過(guò)一系列優(yōu)化操作，使溶殘一次性達(dá)到合格標(biāo)準(zhǔn)——后續(xù)生產(chǎn)無(wú)需再經(jīng)過(guò)原本繁瑣的烘料循環(huán)，效率顯著提升。

在分析方面，團(tuán)隊(duì)充分尊重客戶對(duì)原有分析方法的堅(jiān)持，同時(shí)嚴(yán)格遵守不同地區(qū)的申報(bào)法規(guī)要求。依托公司一體化分析平臺(tái)，團(tuán)隊(duì)高效完成了50余項(xiàng)方法驗(yàn)證與確認(rèn)、約30項(xiàng)對(duì)照品與雜質(zhì)的標(biāo)化及結(jié)構(gòu)確證，以及10余項(xiàng)穩(wěn)定性及影響因素研究，為項(xiàng)目推進(jìn)提供了有力保障。

最終，在研發(fā)、生產(chǎn)、分析等各團(tuán)隊(duì)的通力合作下，合全藥業(yè)團(tuán)隊(duì)僅用7個(gè)月，就以“零偏差”的質(zhì)量穩(wěn)定性，完成了工藝性能確認(rèn)（PPQ）批次的生產(chǎn)與交付。

當(dāng)項(xiàng)目進(jìn)入NDA申報(bào)的關(guān)鍵節(jié)點(diǎn)，新的考驗(yàn)隨之而來(lái)。申報(bào)團(tuán)隊(duì)遇到了預(yù)期之中的發(fā)補(bǔ)問(wèn)題。由于項(xiàng)目以另一地區(qū)的申報(bào)資料作為主體開展本地申報(bào)，而不同國(guó)家和地區(qū)的申報(bào)標(biāo)準(zhǔn)存在差異，推進(jìn)過(guò)程中出現(xiàn)了十多項(xiàng)需補(bǔ)充和修改的材料，涉及生產(chǎn)工藝、分析方法等方面。按照常規(guī)流程，這類工作需耗時(shí)5個(gè)月之久。由于發(fā)補(bǔ)的完成周期直接決定著上市日期，其推進(jìn)速度自然成為客戶尤其關(guān)切的問(wèn)題。

依托公司一體化平臺(tái)與團(tuán)隊(duì)豐富的經(jīng)驗(yàn)，項(xiàng)目團(tuán)隊(duì)通過(guò)緊密的客戶溝通，以及工藝研發(fā)、分析團(tuán)隊(duì)的通力協(xié)作，確保項(xiàng)目的高效推進(jìn)。最終，團(tuán)隊(duì)僅用2個(gè)月就完成了雜質(zhì)制備、清除研究、分析方法的開發(fā)和驗(yàn)證，以及批次分析等工作，確保了申報(bào)如期推進(jìn)。

這種在關(guān)鍵時(shí)刻可靠執(zhí)行、快速解決問(wèn)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?！?/p>

圖片來(lái)源：123RF

每一次信任，都是新的起點(diǎn)

后來(lái)，這款藥物的所有權(quán)幾經(jīng)變更，但無(wú)論歸屬如何變化，有一個(gè)選擇卻從未動(dòng)搖：該藥物的后續(xù)生產(chǎn)，始終交由藥明康德團(tuán)隊(duì)負(fù)責(zé)。

這段始于質(zhì)疑的合作，最終轉(zhuǎn)變成為跨越時(shí)間與變局的信任。

這份信任從來(lái)不是偶然。多年來(lái)，每一個(gè)環(huán)節(jié)的扎實(shí)落地，每一次問(wèn)題的快速響應(yīng)，背后都是藥明康德一體化平臺(tái)的能力與團(tuán)隊(duì)的智慧。正是這種緊密協(xié)作、價(jià)值共創(chuàng)的方式，讓一次次交付不僅兌現(xiàn)了承諾，更贏得了長(zhǎng)期并肩的默契。

而這樣的案例，并非孤例。它們是藥明康德團(tuán)隊(duì)在一次次攻堅(jiān)中，反復(fù)打磨、沉淀下來(lái)的技術(shù)和能力的縮影。二十多年來(lái)，公司憑借高效、高質(zhì)量的交付，持續(xù)將眾多新客戶轉(zhuǎn)化為長(zhǎng)期合作伙伴，并把每一次信任都視作新的起點(diǎn)。依托于一體化、端到端的CRDMO平臺(tái)，藥明康德將繼續(xù)賦能全球客戶，將科學(xué)創(chuàng)新更快、更穩(wěn)地轉(zhuǎn)化為造?；颊叩寞煼?。

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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