媒體聲音 | 藥明康德一體化CRDMO如何讓創(chuàng)新療法更快造?；颊?| Bilingual

近年來(lái)，新藥研發(fā)的復(fù)雜程度不斷提升：從多肽和寡核苷酸，到靶向蛋白降解分子以及其他新分子類型，想要推進(jìn)這些創(chuàng)新療法從概念走向臨床，離不開先進(jìn)的化學(xué)技術(shù)、專業(yè)的生產(chǎn)能力以及高度協(xié)同的研發(fā)與生產(chǎn)體系。

為了更好地賦能全球創(chuàng)新者應(yīng)對(duì)這些挑戰(zhàn)，藥明康德通過(guò)獨(dú)特的一體化CRDMO平臺(tái)，將研究、開發(fā)與生產(chǎn)能力整合在一個(gè)全球化的體系中，幫助新藥研發(fā)企業(yè)簡(jiǎn)化研發(fā)流程，并以二十多年來(lái)積累的經(jīng)驗(yàn)，協(xié)助客戶更高效地推進(jìn)研發(fā)項(xiàng)目，讓創(chuàng)新療法加速走向患者。

近日，藥明康德高級(jí)副總裁、寡核苷酸和多肽事業(yè)部及化學(xué)業(yè)務(wù)平臺(tái)商務(wù)運(yùn)營(yíng)部負(fù)責(zé)人盧羽女士接受行業(yè)媒體Fierce Biotech采訪，分享了藥明康德的一體化能力和全球網(wǎng)絡(luò)協(xié)同，如何以“藥明速度”，加速推動(dòng)客戶新一代創(chuàng)新療法的開發(fā)。

以下是報(bào)道全文，點(diǎn)擊“閱讀原文/Read More”即可訪問(wèn)原文頁(yè)面。

Fierce Biotech：隨著創(chuàng)新分子模式不斷出現(xiàn)，全球生物醫(yī)藥產(chǎn)業(yè)的合作模式也在發(fā)生變化。在您看來(lái)，醫(yī)藥企業(yè)在開展研發(fā)與生產(chǎn)合作時(shí)，有著哪些變化？

盧羽：一個(gè)明顯的變化，是醫(yī)藥企業(yè)對(duì)合作伙伴角色的認(rèn)識(shí)發(fā)生了轉(zhuǎn)變。過(guò)去，研發(fā)和生產(chǎn)合作更多被視為外包服務(wù)，而現(xiàn)在則越來(lái)越多地被視為一種戰(zhàn)略協(xié)作關(guān)系。這一轉(zhuǎn)變主要由三個(gè)關(guān)鍵需求所驅(qū)動(dòng)，即創(chuàng)新療法的需要、對(duì)于全球質(zhì)量的要求、以及項(xiàng)目開發(fā)的速度。

首先，療法本身正變得更加復(fù)雜。隨著新藥研發(fā)的邊界拓展至靶向蛋白降解、多肽、寡核苷酸以及復(fù)雜偶聯(lián)物等新型分子類型，相關(guān)的研發(fā)項(xiàng)目相比以往，也需要更專業(yè)的化學(xué)能力、全新的生產(chǎn)技術(shù)，以及覆蓋多個(gè)研發(fā)階段的綜合經(jīng)驗(yàn)。在這樣的背景下，合作伙伴不僅需要具備執(zhí)行能力，還需要提供科學(xué)洞察和解決問(wèn)題的能力。

其次，越來(lái)越多的企業(yè)從立項(xiàng)開始，就在規(guī)劃未來(lái)的全球新藥開發(fā)計(jì)劃。這意味著合作伙伴需要在統(tǒng)一的全球質(zhì)量體系下開展工作，且能夠滿足不同地區(qū)的監(jiān)管要求，從而確保項(xiàng)目從開發(fā)到商業(yè)化供應(yīng)的順利銜接。

第三，速度在當(dāng)下也變得尤為關(guān)鍵。客戶希望在不犧牲質(zhì)量的前提下，更高效地推進(jìn)項(xiàng)目進(jìn)展，因?yàn)槊恳粋€(gè)項(xiàng)目背后，都有等待新治療方案的患者。

舉一個(gè)最近的例子。一家開發(fā)復(fù)雜雙靶點(diǎn)siRNA-GalNAc偶聯(lián)藥物的客戶找到我們，希望在8個(gè)月內(nèi)完成支持IND申報(bào)所需的完整CMC工作。該項(xiàng)目面臨諸多挑戰(zhàn)，比如，分子的復(fù)雜性導(dǎo)致單鏈合成、純化后的產(chǎn)率及純度均較低。雙鏈的雜質(zhì)譜復(fù)雜且不穩(wěn)定，為分析方法開發(fā)帶來(lái)不小的挑戰(zhàn)。

針對(duì)這些問(wèn)題，我們與客戶密切合作，共同尋找解決方案。在合成工藝開發(fā)環(huán)節(jié)，我們的團(tuán)隊(duì)?wèi){借豐富的項(xiàng)目經(jīng)驗(yàn)，快速確定了適用的固載及合成策略，將正義鏈粗品純度提升了超85%，最終收率提升了超90%。同時(shí)，團(tuán)隊(duì)開發(fā)出穩(wěn)健的分析方法，將關(guān)鍵雜質(zhì)與主峰成功分離。此外，多支內(nèi)部團(tuán)隊(duì)并行推進(jìn)開發(fā)工作，使從原料藥到制劑的工藝開發(fā)、分析研究和生產(chǎn)準(zhǔn)備能夠同步開展。最終，我們按時(shí)交付了IND申報(bào)所需的材料，幫助客戶順利達(dá)成關(guān)鍵里程碑。

在這樣的背景下，一體化平臺(tái)的重要性愈發(fā)凸顯。通過(guò)在統(tǒng)一的全球質(zhì)量體系中打通化學(xué)開發(fā)、生產(chǎn)制造與供應(yīng)環(huán)節(jié)，各團(tuán)隊(duì)可以并行推進(jìn)工作，提前預(yù)判研發(fā)過(guò)程中可能存在的挑戰(zhàn)。這樣才能保持高質(zhì)量的同時(shí)，更加高效地推進(jìn)研發(fā)項(xiàng)目。

Fierce Biotech：創(chuàng)新治療模式需要全新的化學(xué)和生產(chǎn)技術(shù)。藥明康德近年來(lái)在這些方面建設(shè)了哪些新能力？

盧羽：過(guò)去幾年，我們重點(diǎn)建設(shè)了一系列關(guān)鍵技術(shù)平臺(tái)，以解決創(chuàng)新藥物開發(fā)過(guò)程中遇到的技術(shù)挑戰(zhàn)。

其中一個(gè)重要平臺(tái)是流動(dòng)化學(xué)（flow chemistry）技術(shù)。它能實(shí)現(xiàn)連續(xù)化生產(chǎn)，提升化學(xué)反應(yīng)的控制能力、安全性以及規(guī)?；a(chǎn)效率，尤其適用于復(fù)雜反應(yīng)。另一個(gè)關(guān)鍵平臺(tái)則是生物酶催化技術(shù)。通過(guò)應(yīng)用新型酶和超高通量篩選技術(shù)，我們能夠優(yōu)化多肽和寡核苷酸這類復(fù)雜分子的合成路線。

此外，在多肽和寡核苷酸方面，我們的能力也在不斷演進(jìn)。在多肽領(lǐng)域，我們開發(fā)了多種一體化工藝路徑，通過(guò)將固相合成與液相合成相結(jié)合（SPPS–LPPS混合策略）來(lái)提升效率；在下游環(huán)節(jié)，我們根據(jù)具體多肽分子的特性和開發(fā)需求，靈活采用先進(jìn)的純化及API分離技術(shù)，如切向流過(guò)濾（TFF）、連續(xù)流色譜及噴霧干燥，助力提高收率、工藝穩(wěn)定性和可擴(kuò)展性。

在寡核苷酸領(lǐng)域，我們同樣開發(fā)了多種創(chuàng)新工藝技術(shù)。比如固相與液相合成（SPOS和LPOS），酶促合成等進(jìn)一步拓展合成復(fù)雜序列的效率；在下游純化與分離方面，我們采用薄膜蒸發(fā)（TFE）、連續(xù)流色譜等創(chuàng)新技術(shù)，簡(jiǎn)化下游處理流程、減少工藝步驟。

在此基礎(chǔ)上，我們不斷強(qiáng)化制劑（DP）能力，以應(yīng)對(duì)遞送方面的挑戰(zhàn)。在多肽領(lǐng)域，我們支持從臨床前到商業(yè)化階段的口服和注射劑開發(fā)與生產(chǎn)。截至目前，我們已支持超70個(gè)臨床前及10多個(gè)臨床階段的口服多肽項(xiàng)目開發(fā)。在寡核苷酸方面，我們的脂質(zhì)納米顆粒（LNP）等遞送技術(shù)也能有效提升療效，拓寬藥物治療范圍。此外，我們近期在中國(guó)及瑞士的多個(gè)基地持續(xù)提升噴霧干燥產(chǎn)能，更好地助力合作伙伴解決復(fù)雜分子在生物利用度方面的挑戰(zhàn)。

綜合來(lái)看，這些能力使我們能夠?yàn)樾路肿禹?xiàng)目提供從早期開發(fā)到商業(yè)化生產(chǎn)的一體化支持，幫助客戶有效應(yīng)對(duì)療法的復(fù)雜性，也能更高效地推動(dòng)項(xiàng)目走向患者。

Fierce Biotech：您提到了泰興和庫(kù)威的基地。在您看來(lái)，藥明康德的全球化網(wǎng)絡(luò)能怎樣更好地推進(jìn)客戶的研發(fā)項(xiàng)目？能否分享一個(gè)具體案例？

盧羽：我們的目標(biāo)是幫助客戶順利實(shí)現(xiàn)從研發(fā)到生產(chǎn)的轉(zhuǎn)化，同時(shí)保持供應(yīng)的靈活性和穩(wěn)健性。而我們的全球化基地，可以通過(guò)不同的能力，將新技術(shù)轉(zhuǎn)化為可規(guī)?；慕鉀Q方案，高效推進(jìn)客戶的項(xiàng)目。

例如，前面提到的瑞士庫(kù)威基地提供口服固體制劑生產(chǎn)以及包裝和標(biāo)簽服務(wù)，使客戶能夠向全球市場(chǎng)供應(yīng)成品藥。目前，該生產(chǎn)基地正在支持多款商業(yè)化產(chǎn)品，供應(yīng)瑞士、美國(guó)、歐盟、英國(guó)、日本、澳大利亞、加拿大、新西蘭和中國(guó)等市場(chǎng)。同時(shí)，全新的PSD-4噴霧干燥生產(chǎn)線預(yù)計(jì)將于今年第四季度在庫(kù)威基地投入運(yùn)行。

▲藥明康德瑞士庫(kù)威基地

在美國(guó)，正在建設(shè)中的特拉華州米德爾頓（Middletown）基地，預(yù)計(jì)也將在2026年第四季度投入運(yùn)營(yíng)。屆時(shí)該基地將具備口服固體制劑生產(chǎn)能力，同時(shí)還將提供包裝、貼標(biāo)、配送服務(wù)以及分析開發(fā)與質(zhì)量控制檢測(cè)。2027年，米德爾頓基地還將擴(kuò)展無(wú)菌灌裝能力，包括西林瓶、卡式瓶和預(yù)充針生產(chǎn)，從而支持寡核苷酸和多肽等創(chuàng)新藥物開發(fā)。

美國(guó)圣地亞哥基地在全球供應(yīng)網(wǎng)絡(luò)中同樣發(fā)揮著重要作用，提供從原料藥到制劑的一體化服務(wù)，以滿足臨床供應(yīng)需求。

與此同時(shí)，位于亞洲的生產(chǎn)基地也在持續(xù)擴(kuò)展布局。以泰興基地為例，該基地目前已投產(chǎn)12個(gè)生產(chǎn)車間。此外，兩個(gè)全新的小分子原料藥生產(chǎn)車間預(yù)計(jì)將在2026年投入運(yùn)營(yíng)，而用于寡核苷酸、多肽和PMO生產(chǎn)的兩個(gè)新車間預(yù)計(jì)在2027年投產(chǎn)。

我們的新加坡基地也在建設(shè)中，同樣預(yù)計(jì)在2027年投入運(yùn)營(yíng)，進(jìn)一步提升原料藥全球供應(yīng)的靈活性，更好地支持小分子及寡核苷酸、多肽藥物及相關(guān)化學(xué)偶聯(lián)物商業(yè)化生產(chǎn)需求。

此外，無(wú)錫制劑基地也在持續(xù)提升無(wú)菌注射劑研發(fā)及生產(chǎn)能力。目前該基地配備5條生產(chǎn)線，其中包括1條高活注射劑生產(chǎn)線，年總產(chǎn)能已超過(guò)1億支注射劑，支持西林瓶（水針及凍干粉針）、預(yù)充針及卡式瓶的無(wú)菌灌裝。

這些基地共同構(gòu)成了一個(gè)全球化的一體化平臺(tái)，使客戶可以依托全球網(wǎng)絡(luò)下的統(tǒng)一質(zhì)量體系，完成從研發(fā)到商業(yè)化生產(chǎn)的全流程。通過(guò)持續(xù)優(yōu)化全球運(yùn)營(yíng)和一體化平臺(tái)，我們能夠滿足不斷增長(zhǎng)的客戶需求，同時(shí)保持高效和可靠性。

借助全球基地賦能新藥開發(fā)項(xiàng)目加速推進(jìn)的故事每天都在發(fā)生，這里我想分享一個(gè)臨床3期項(xiàng)目從客戶基地成功轉(zhuǎn)到瑞士庫(kù)威基地生產(chǎn)的案例。當(dāng)時(shí)，多個(gè)團(tuán)隊(duì)緊密合作，5個(gè)月內(nèi)快速完成了生產(chǎn)工藝轉(zhuǎn)移和放大。其中，設(shè)備產(chǎn)線的兼容性評(píng)估、分析方法驗(yàn)證以及原材料和包裝材料的采購(gòu)等，均加速提前完成。最終，通過(guò)提前協(xié)調(diào)規(guī)劃及無(wú)縫平行推進(jìn)，該項(xiàng)目憑借高效執(zhí)行得以圓滿完成，這使得客戶能夠按時(shí)提交NDA（New Drug Application，新藥上市申請(qǐng)），該藥已經(jīng)成功獲批上市。

Fierce Biotech：面對(duì)如此廣泛的全球生產(chǎn)布局，如何確保不同地區(qū)始終保持一致的質(zhì)量與監(jiān)管合規(guī)標(biāo)準(zhǔn)？

盧羽：質(zhì)量始終是我們所有工作的基礎(chǔ)。隨著全球業(yè)務(wù)的不斷拓展，確保不同地區(qū)之間保持一致的質(zhì)量標(biāo)準(zhǔn)，是我們的核心重點(diǎn)之一。

為此，我們建立了名為“One Global Quality System”的全球統(tǒng)一質(zhì)量體系，在所有基地之間統(tǒng)一質(zhì)量標(biāo)準(zhǔn)、操作流程和培訓(xùn)體系。各基地遵循統(tǒng)一的GMP規(guī)范和標(biāo)準(zhǔn)化操作程序，從而確保全球范圍內(nèi)的研發(fā)和生產(chǎn)活動(dòng)都符合一致的質(zhì)量與監(jiān)管要求。

這一體系的重要組成部分是全球數(shù)字化平臺(tái)，用于管理質(zhì)量文件和相關(guān)數(shù)據(jù)。通過(guò)從傳統(tǒng)紙質(zhì)體系轉(zhuǎn)向數(shù)字化系統(tǒng)，信息能夠在不同基地之間實(shí)現(xiàn)一致的共享和解讀，使各團(tuán)隊(duì)在質(zhì)量要求方面形成統(tǒng)一的理解和執(zhí)行標(biāo)準(zhǔn)。

這一體系也在實(shí)際監(jiān)管檢查中得到了驗(yàn)證。僅2025年，藥明康德就接受了741次來(lái)自全球客戶、監(jiān)管機(jī)構(gòu)及第三方的質(zhì)量審計(jì)和檢查，無(wú)嚴(yán)重發(fā)現(xiàn)項(xiàng)。這說(shuō)明我們的質(zhì)量夠硬。

Fierce Biotech：感謝您的分享。展望未來(lái)，哪些創(chuàng)新領(lǐng)域最讓您感到興奮？

盧羽：未來(lái)幾年的藥物創(chuàng)新非常令人期待。我們看到多個(gè)領(lǐng)域正在迅速發(fā)展，持續(xù)重塑新藥的開發(fā)方式。

例如，多肽藥物正在改變代謝性疾病的治療模式，而多肽偶聯(lián)藥物等新型靶向遞送技術(shù)也在不斷拓展精準(zhǔn)醫(yī)學(xué)的應(yīng)用前景。同時(shí)，寡核苷酸療法正從罕見病治療逐步拓展至心血管疾病和神經(jīng)系統(tǒng)疾病等更廣泛的治療領(lǐng)域。

這些進(jìn)展為行業(yè)帶來(lái)了新的機(jī)遇，同時(shí)也對(duì)化學(xué)技術(shù)、遞送方法、生產(chǎn)模式以及供應(yīng)體系提出了更高要求。

通過(guò)持續(xù)強(qiáng)化自身能力、建設(shè)全球基地、并與合作伙伴緊密協(xié)作，我們希望為客戶同時(shí)提供速度、質(zhì)量和價(jià)值優(yōu)勢(shì)，也讓更多創(chuàng)新療法更快惠及全球患者。

How WuXi AppTec’s Integrated Platform Is Helping Therapies Move Faster from Discovery to Patients

Drug discovery is entering a new phase of complexity. From peptides and oligonucleotides to targeted protein degraders and other emerging modalities, many of today’s therapies require advanced chemistry, specialized manufacturing technologies and coordinated execution to move from concept to clinic.

To help innovators address these challenges, WuXi AppTec has built an integrated CRDMO platform that connects discovery, development and manufacturing capabilities across multiple regions. By bringing these functions together within a unified system, the platform enables drug developers to advance programs more efficiently, reduce operational handoffs and move promising therapies toward patients faster.

Recently, Fierce Biotech spoke with Yu Lu, Senior Vice President, Head of WuXi TIDES and WuXi Chemistry Business Operations at WuXi AppTec, about how integrated capabilities, cross-site collaboration and what many clients call “WuXi Speed” are helping advance the next generation of medicines.

Fierce Biotech: As new drug modalities emerge, development and manufacturing partnerships are also evolving. From your perspective, what shifts are you seeing in how pharmaceutical companies approach development and manufacturing collaborations today?

Yu Lu:One of the most significant changes is how pharmaceutical companies view their development and manufacturing partners.What was once treated simply as transactional, outsourcing has increasingly become a strategic collaboration, driven by three key needs: innovation, global quality, and speed.

First, molecules are becoming more complex. As drug discovery expands into modalities such as targeted protein degradation, peptides, oligonucleotides, and complex conjugates, programs require specialized chemistry, new manufacturing technologies, and expertise across multiple stages of development. In this context,partners are expected not only to execute, but also to contribute scientific insight and problem-solving capabilities.Second, more companies are planning for global drug development and launch.This requires partners who can operate under consistent global quality systems and meet regulatory expectations across regions, ensuring a smooth path from development to commercial supply.

Third, speed has become critical.Clients are looking for ways to move programs forward more efficiently, without compromising quality, because behind every program are patients waiting for new treatment options.

Let me share a recent example.A client developing a complex divalent-siRNA-GalNAc conjugate approached us with the need for a complete CMC package to support an IND filing within just 8 months.The complexity of the conjugate led to low yield and purity in single-strand synthesis and purification. Additionally, the impurity profile of the duplex was complicated and unstable, posing significant challenges for analytical method development.

Our approach was to work closely with the client, addressing these challenges collaboratively while leveraging our expertise. Our team, drawing on extensive project experience, quickly identified suitable solid support and synthesis strategies.This increased the purity of the crude sense strand by more than 85% and enhanced the final yield by over 90%.The team also developed a robust analytical method to ensure that key impurities could be separated from the main peak. Simultaneously, multiple in-house teams coordinated development activities from API to drug product, ensuring alignment and progress.As a result, we delivered the necessary materials for the IND filing on schedule, enabling the client to meet their milestones.This is where an integrated platform can make a real difference.By connecting chemistry development, manufacturing, and supply within a unified system, teams can operate in parallel, anticipate challenges, and maintain consistent quality across regions.The result is faster, more reliable progression from discovery to patient access—without compromising the standards required for global development.

Fierce Biotech: To meet the requirement of these new modalities, the underlying chemistry and manufacturing technologies also need to evolve. What are some of the key capabilities WuXi AppTec has been building to support this?

Yu Lu:Over the past several years, we have focused on developing enabling technologies that help address the technical challenges associated with newer drug modalities.

One important area is flow chemistry, which, as you know, enables continuous manufacturing processes that improve reaction control, safety and scalability, particularly for complex or hazardous reactions.Another key capability is biocatalysis.By applying novel enzymes and ultra-high throughput screening technologies, we can streamline synthetic routes for challenging molecules, including small molecules, peptides and oligonucleotides.

Our capabilities in peptides and oligonucleotides also continue to advance alongside the growing complexity of these modalities.For peptides, we have developed integrated process approaches such as combining solid-phase and liquid-phase synthesis (SPPS–LPPS hybrid), enabling greater efficiency and scalability for longer and more complex sequences. Downstream, we apply advanced purification and API isolation technologies such as tangential flow filtration, continuous flow chromatography and spray drying to help improve yield, process robustness, and scalability.

In oligonucleotides, we bring a similarly flexible and integrated approach. Innovations such as thin film evaporation (TFE), continuous flow chromatography help streamline downstream handling and reduce processing steps, while biocatalytic fragment ligation expands the toolkit for constructing more complex sequences.

These advances are complemented by growing drug product capabilities designed to address delivery challenges.For peptides, we support both oral and parenteral drug product development and manufacturing from preclinical through commercial stages. So far, our team has supported over 70 preclinical and more than 10 clinical phase oral peptide projects. For oligonucleotides, delivery technologies such as lipid nanoparticles (LNPs) play a critical role in improving therapeutic performance.

In addition, we recently expanded spray drying capacity across multiple sites in China and Switzerland, helping address bioavailability challenges for increasingly complex molecules.

Together, these capabilities enable us to support new modality programs from early development through manufacturing, helping clients navigate increasing complexity while advancing their programs more efficiently toward patients.

Fierce Biotech: How does WuXi AppTec’s global site footprint support clients as programs move toward manufacturing and commercialization? Could you share a specific example?

Yu Lu:Infrastructure is essential for translating new technologies into scalable solutions. Our goal is to help clients move smoothly from development into manufacturing while maintaining flexibility and operational resilience.

In Couvet, for example, we provide oral solid dosage manufacturing as well as packaging and labeling capabilities, allowing clients to supply finished drug products to global markets. In recent years we have expanded both manufacturing and packaging capacity there to support larger programs and increasing commercial demand. Today, the facility supplies multiple commercial drug products to Switzerland, the United States, European Union (EU), the United Kingdom, Japan, Australia, Canada, New Zealand, and China. A new PSD-4 spray dryer is expected to become operational in Q4 this year.

▲WuXi AppTec’s site in Couvet, Switzerland

In the U.S., our Middletown, Del., campus, is expected to become operational in Q4 of this year. At that time, it will provide oral solid dosage manufacturing capabilities. The site will also offer packaging, labeling, distribution services and analytical development with quality control testing. Sterile fill-finish manufacturing will be available in 2027, and include vials, cartridges and prefilled syringes. These capabilities will support new modalities such as oligonucleotide and peptide drug products. Our San Diego site acts as another critical hub, enabling a seamless, integrated transition from API to drug product manufacturing for clinical supply.

Meanwhile, we continue to expand API manufacturing capabilities at our sites in Asia. There are 12 manufacturing plants currently operational at our Taixing site. Two new small molecule API plants are expected to become operational this year, and two additional plants dedicated to oligonucleotide, peptide and PMO production are currently under construction and scheduled to be operational in 2027.

Our Singapore site, currently under construction and also will be operational in 2027, will further enhance our global API manufacturing network for both small molecule and TIDES drugs.

Our Wuxi City site has continued to expand its sterile injectable formulation and manufacturing capabilities in recent years. Now featuring five injectable lines, including one dedicated to high potency drugs, the site's total annual capacity exceeds 100 million units. These lines support various dosage forms, including liquid and lyophilized vials, pre-filled syringes, and cartridges.

Together, these locations operate as part of a single integrated platform. Instead of coordinating work across multiple vendors, clients can rely on a unified global network with one global quality system that supports their programs from development through commercialization. Through continuous optimization of our global operations and integrated platform, we are able to accommodate increasing demand while maintaining high efficiency and reliability.

One example that comes to mind involved WuXi AppTec’s successful mobilization of our Couvet site to manufacture a drug in Phase 3 clinical trials that the client had handled at its own site before ramping up production.Multiple teams collaborated closely, completing the manufacturing process transition and scale-up within five months. Detailed planning covered equipment compatibility assessments, analytical method validation, and procurement of raw and packaging materials — all completed well ahead of schedule.Through coordinated planning and parallel execution, this project was flawlessly completed through efficient work that enabled the client to submit the NDA (New Drug Application) on time. The drug was subsequently approved for market launch.

Fierce Biotech: With such a broad manufacturing footprint, how do you ensure consistent quality and regulatory compliance across regions?

Yu Lu:Quality is fundamental to everything we do. As our operations have expanded internationally, maintaining consistent quality standards across regions remains a top priority.

To support this,we implemented “One Global Quality System,” which aligns quality standards, procedures and training across all sites.Instead of each location operating under separate local processes, teams follow a shared framework of GMP practices and standardized procedures. This assures that work performed in different regions meets the same expectations for quality and regulatory compliance.

An important part of this system is the use of global digital platforms to manage documentation and quality data. Moving away from paper-based processes allows information to be shared and interpreted consistently across sites, helping teams operate with a common understanding of quality requirements.

This framework has also been validated through regulatory inspections.In 2025 alone, WuXi AppTec underwent 741 quality audits conducted by global clients, regulatory authorities, and independent third parties, with zero critical findings.

Fierce Biotech: Looking ahead, what areas of innovation are you most excited about?

Yu Lu:The next few years will be very exciting for therapeutic innovation. We are seeing rapid progress in several areas that are reshaping how medicines are developed.

Peptide-based medicines are transforming treatment approaches in metabolic diseases, while increasingly sophisticated peptide conjugates and other targeted delivery technologies are expanding the possibilities for precision medicine. At the same time, oligonucleotide therapeutics are moving beyond rare diseases into broader areas including cardiovascular and neurological conditions.

These advances create new opportunities, but they also require new chemistry and drug delivery technologies, manufacturing approaches and supply chain solutions.

Our focus is to continue strengthening our integrated platform so that clients can develop and manufacture these next-generation medicines more efficiently. By combining global infrastructure, new technologies and close collaboration with our partners, we aim to deliver speed, quality and value while helping innovative therapies reach patients around the world.

參考資料：

[1] How WuXi AppTec’s Integrated Platform Is Helping Therapies Move Faster from Discovery to Patients. Retrieved April 20, 2026 from https://www.fiercebiotech.com/sponsored/how-wuxi-apptecs-integrated-platform-helping-therapies-move-faster-discovery-patients

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