千錘百煉磨出從容底氣，做新藥研發征程的“較真”守護者 | Bilingual

編者按：“讓天下沒有難做的藥，難治的病”，是初心，更是愿景。自成立以來，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眾多合作伙伴。不斷發展的，是規模與能力；始終堅守的，是夢想與承諾。本系列文章將立足藥明康德一體化CRDMO平臺，系統講述公司不斷深化的能力和規模體系，以平臺承載信任，持續賦能客戶創新，共同推動更多突破性療法走向病患。

2026年初的一個清晨，陽光透過潔凈明亮的玻璃窗，灑落在藥明康德測試事業部上海生物分析部實驗室里。精密的儀器泛著溫潤而沉靜的光澤，研究員們已各就各位，一切井然有序。與往常不同的是，這一天，實驗室迎來了兩位特殊的“客人”——美國病理學家協會（CAP）的現場審計官。

實驗室的研究員們并沒有因審計官的到來而打亂步調，他們熟練地調試儀器、整理試劑，電腦屏幕上跳動著項目進度表，一切如常。

審計官們有條不紊地穿梭在各個實驗臺之間，翻看記錄、詢問操作、抽查數據，全程沒有一句多余的話語。隨著各項檢查的推進，他們原本緊繃的神情漸漸舒展，最終浮現出滿意的笑容。

當審計官合上文件的那一刻，結果沒有意外：無嚴重發現項，順利完成審計。

審計不是考驗，是質量的“全面體檢”

此次完成CAP審計并非偶然。自2005年藥明康德生物分析部成立以來，實驗室已多次通過中國國家藥品監督管理局（NMPA，原CFDA）、美國食品藥品監督管理局（FDA）、經濟合作與發展組織（OECD）、歐洲藥品管理局（EMA）、美國病理學家協會（CAP）、日本醫藥品醫療器械綜合機構（PMDA）的體系和項目核查。這些成果，是團隊多年來深耕“高標準質量體系”的有力見證。

圖片來源：123RF

當被問及為何能每一次都高質量完成全球權威機構的審計時，藥明康德測試事業部生物分析部中國區負責人童瑩女士給出的回答簡潔而堅定：“我們強調‘any time is ready’（隨時準備著）。”

在日常工作時，生物分析團隊始終在思考一個問題：今天完成的每一個項目，是否都能經得起未來任何一次審計的檢驗？秉持這一理念，團隊在質量體系設計之初就已將數據可靠性、可追溯性以及合規要求前置，并融入到日常工作的每一個環節。

在童瑩看來，審計官是來幫團隊做“體檢”的——既能核驗現有質量體系與項目執行的合規性，更能識別潛在的改進空間。因此，生物分析團隊一直以來都是以積極開放的心態歡迎每一次審計的到來。

這份從容，源于生物分析團隊對細節的極致堅守。在行業慣例或法規未作強制要求的環節，生物分析團隊依然精益求精。以關鍵數據復核為例，即便部分步驟未強制要求雙人復核，團隊仍主動設置該流程，牢牢守住數據準確性的底線。

正是這份對細微之處也一絲不茍的堅持，贏得了審計機構的高度認可。在數次OECD審計中，審計組對生物分析部成熟的GLP體系建設與高標準質量給予了高度評價，認為其在質量體系、文件管理、數據記錄與歸檔等方面持續精進，尤其認可計算機化系統驗證方面的規范性、SOP的合規性，以及記錄的透明性與可追溯性。

“只要把每一個細節堅守到位，監管機構與客戶的滿意，自然水到渠成。”童瑩補充道。

這種對質量的堅守，也是整個藥明康德質量體系的縮影。2025年，藥明康德全年接受各類質量審計和檢查共計741次，包括680次客戶審計，56次監管機構檢查，以及5次獨立第三方審計，所有審計保持“無嚴重發現項”。

以“質量源于設計”，適配全球監管需求

從創立伊始，藥明康德就嚴格遵循全球高標準。面對來自不同國家和地區監管機構以及專業認證組織的多元要求，生物分析部的核心競爭力之一，就在于能夠實現“多標并行、無縫適配”。

“不同機構的審計關注點不同。”童瑩解釋道，“有些機構強調數據完整性與臨床數據科學可靠性，有些則強調研究全過程的體系化，也有機構更關注臨床檢測實驗室的質量控制與持續改進。我們的質量體系能夠確保所有項目都可在相應的合規流程下運行。”

作為藥明康德一體化CRDMO平臺的重要組成部分，生物分析部始終貫徹公司推行的“質量源于設計（Quality by Design）”理念。這一理念并非僅停留在口號上，而是作為公司層面的核心戰略，深深植根于全球每一個基地的運營實踐中。從項目啟動的源頭開始，高標準的質量控制就被預先植入到每一個環節，確保整個流程經得起隨時隨地的檢驗。

在這一頂層設計的指引下，生物分析團隊展現出全球法規適配能力。面對復雜的跨地區申報需求，團隊堅持“一套規則，全球通行（One Rule for All）”的原則，將FDA、NMPA、EMA等不同監管機構的嚴格要求，前置融入到流程設計中。例如，當一個項目需要同時在亞洲、北美，以及歐洲多地申報時，生物分析團隊能夠基于公司深厚的積淀，迅速整合出一套兼顧多方標準的檢測方案，確保項目在全球范圍內合規推進。

圖片來源：123RF

這種源自公司層面的體系優勢，能夠為客戶提供可靠的確定性。選擇藥明康德，意味著選擇了一個已經完成全球多家權威機構嚴格審查的成熟質量體系。這不僅有效規避了因標準差異導致需補充實驗的風險，更大幅降低了審計帶來的時間不確定性，為客戶的新藥研發項目保駕護航。

同時，高頻次的全球審計也反哺了質量體系的進化。生物分析團隊將每一次審計視為復盤與優化的契機，通過洞悉全球監管的最新趨勢，不斷對流程進行“優化”與“強化”。這種“接受檢驗-復盤優化”的正向循環，使得團隊能夠持續為客戶提供“安心省力”的交付體驗，真正實現了質量與效率的雙重保障。

數字化賦能，讓“又快又穩”成為常態

“又快又穩”是客戶對藥明康德的一致贊譽。在藥明康德，速度與質量從來不會被取舍。

談及生物分析團隊如何實現“又快又穩”，童瑩給出了團隊的解題思路：“質量與效率并不矛盾。以數字化為支撐，做好科學的流程設計和精細化管理，就能在嚴守質量底線的同時實現效率躍升，讓‘又快又穩’成為常態。”

在藥明康德2025年的投資者日上，生物分析團隊的數字化提效實踐作為公司精益運營的成果之一得到了展示。數據顯示，依托數字化管理平臺，團隊將瓶頸環節的周轉時長降低30%，分析時長降低35%。

這背后是三項核心數字化舉措的落地：一是項目節點可視化，打破信息壁壘，讓團隊實時掌握項目進度；二是自動化數據流轉與審計追蹤，減少人工干預，降低人為誤差，實現數據全程可追溯；三是風險預警提前介入，將過去“人工發現瓶頸”的被動模式，轉變為“系統提前提示風險”的主動模式，從源頭規避延誤。

正如童瑩女士所強調的：“我們的效率來自標準化和數字化，絕不是靠壓縮質量步驟來換取的。”

比SOP更重要的，是“為什么這么做”

技術升級與系統打通固然關鍵，但最終仍需人來落地執行。在業內，“高質量交付”早已成為藥明康德的一張名片，其背后，是全球各基地始終保持一致的質量標準與高效的執行能力——既能精準契合全球監管機構的各項法規要求，也能全方位滿足全球客戶的核心需求。這份一致性與執行力，除了依托自上而下的統一培訓、筑牢全員質量認知，更離不開團隊常態化的相互學習、經驗傳承與交流共進。

童瑩坦言：“寫制度或SOP并不難，難的是讓每一位員工真正理解‘為什么必須這樣做’。理解體系背后的邏輯，才是核心。”

圖片來源：123RF

只有深刻理解制度設立的初衷，才能在環境變化時知道如何迭代優化。這種理解并非單次培訓就能達成，而是在生物分析團隊日常帶教、反復研討和問題復盤過程中，逐步沉淀為團隊共識與行為自覺。

這一理念同樣貫穿于新員工培養體系。為確保新員工上崗后操作穩健、合規，團隊建立了嚴格的熟練度測試機制：通過模擬測試與模擬項目進行實操演練，各項指標全部達標后，方能獨立承接客戶項目。

“新員工是質量體系的未來，我們必須守住這個入口。”童瑩補充道。

以科學為燈，照亮創新之路

當藥明康德生物分析團隊把高標準質量內化為基本功時，行業發展的浪潮也帶來了新的考驗——新型多肽藥物、寡核苷酸藥物、XDC偶聯藥物等新分子療法的加速興起，對生物分析領域提出了一道新的時代課題。

這些創新藥物分子的相關法規與技術標準仍在完善，個別領域甚至處于“無現成標準可依”的探索階段。面對新的考驗，團隊牢牢把握三個原則：以科學原理為核心、以風險控制為底線、以全球監管趨勢為參照。

“標準可以慢慢完善，但科學邏輯不能模糊。”童瑩說，“有時監管標準尚未出臺，但我們必須基于科學原理，設計出嚴謹的流程。”

以一個特色生物檢測平臺為例，目前尚未有正式的生物分析方法驗證和樣品分析技術指導原則，但團隊早已從嚴要求，提前建立了嚴格的流程和內部標準。在最近完成的一次監管部門首次對該檢測平臺項目的全面審計中，實現了“無嚴重發現項”。

此外，在多次NMPA審計過程中，團隊主動關注核查專家的關注重點與行業監管趨勢，發掘質量管理的優化方向，始終確保團隊與法規步調一致，提前布局合規管控。

“二十年前，我們在搭建質量體系；今天，我們在用體系支持復雜創新。”童瑩不禁感慨道。隨著行業發展，生物分析的邊界在不斷拓展，從傳統藥物檢測到新型療法研發，從單一環節檢測到全流程合規管控，唯一不變的，是團隊對質量的極致堅守與對科學的敬畏。

夕陽余暉灑在實驗員們專注的臉龐上。儀器平穩運轉，一組組真實、可靠的數據持續生成。對他們而言，每一組嚴謹無誤的數據，都可能成為一款新藥成功獲批、惠及病患的關鍵支持。

在新藥研發的漫長征程中，生物分析是確保質量的“較真”的守護者。藥明康德生物分析團隊，以從容姿態應對每一次檢驗，以專業能力適配多元標準，以對細節的極致堅守，切實踐行著公司“讓天下沒有難做的藥，難治的病”的愿景。

Confidence Behind Clean Audit Records: WuXi AppTec Bioanalytical Services as the Guardian of New Drug Bioanalysis

“Every drug can be made, and every disease can be treated.” Since 2000, 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 numerous partners across more than 30 countries, WuXi AppTec has never stopped moving forward to realize its enduring vision. Find out how WuXi AppTec’s integrated CRDMO platform enables innovation, accelerates R&D, and advances more new therapies to patients around the world.

One morning in early 2026, sunlight streamed through pristine laboratory windows, bathing the Shanghai facilities of WuXi AppTec Bioanalytical Services (BAS). Researchers were engrossed in their work, and precision instruments operated smoothly.

What set this day apart was the arrival of two special guests: on-site auditors from the College of American Pathologists (CAP).

The researchers maintained their focus amidst the audit. They calibrated instruments and prepared reagents with practiced ease. Real-time project timelines were displayed on computer screens as they carried out routine operations.

The auditors moved freely between workstations, reviewing records, verifying procedures, and examining data with minimal unnecessary dialogue.

When the auditors closed their assessment files, the result was expected: zero critical findings and successful completion of the audit.

Treating the Audit as a "Comprehensive Check-up" on Quality

This successful CAP audit is by no means an isolated achievement. Since the establishment of WuXi AppTec Bioanalytical Services in 2005, its affiliated laboratories have repeatedly completed quality system and project-level inspections conducted by major global regulatory bodies, including the National Medical Products Administration (NMPA, formerly CFDA), the U.S. Food and Drug Administration (FDA), the Organisation for Economic Co-operation and Development (OECD), the European Medicines Agency (EMA), the College of American Pathologists (CAP), and the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan. This string of verified accomplishments stands as a solid testament to the team’s long-term commitment to upholding rigorous quality systems.

Image source: 123RF

Asked how the team consistently meets the rigorous standards of global regulatory authorities, Ms. Ying Tong, Head of Bioanalytical Services China at WuXi Testing, stated with simple determination,"Our principle is ‘any time is ready’."

In daily operations, the Bioanalytical Services team constantly asks itself one question: Can every project completed today withstand scrutiny from any future audit?Guided by this philosophy, the team has embedded data integrity, traceability, and compliance requirements into every step of routine workflows from the very design of its quality system.

In Ying’s view, auditors are not there to “find fault”—they are reviewers conducting a “health check” that verifies the compliance of existing quality systems and project execution, while uncovering opportunities for improvement. As such, the Bioanalytical Services team has always welcomed each audit with an open, proactive mindset.

This composure also stems from the team’s strict attention to every detail. Even for procedures not mandated by industry standards or regulatory requirements, the team consistently strives for excellence. Take critical data review as an example: although dual-person verification is not obligatory for certain steps, the team has proactively incorporated this workflow to safeguard the accuracy of experimental data.

Such meticulous attention to detail has earned high recognition from regulatory bodies. During several OECD audits, the inspection team praised WuXi AppTec Bioanalytical Services for its mature GLP framework and strong quality, highlighting continuous refinement in quality systems, document management, data recording, and archiving. The inspectors particularly commended the proactive compliance of standard operating procedures (SOPs) for computerized system validation, as well as the transparency and traceability of records.

“When every detail is held to the highest standard, we earn the trust of regulators and clients,” Ying adds.

This commitment to quality is also a microcosm of the entire WuXi AppTec quality system.In 2025, the company completed a total of 741 quality audits and inspections, including 680 audits by customers, 56 inspections by regulatory authorities, and 5 audits by independent third parties—all with zero critical findings.

Quality by Design: Aligning with Global Regulatory Expectations

Since its founding, WuXi AppTec has strictly adhered to global regulations and technical guidance.A core strength of the Bioanalytical Services team is its ability to operate seamlessly under multiple regulatory frameworks and rigorous professional accreditation standards.

“Different regulators focus on different priorities,” Ying explains. “Our quality systems ensure that all projects operate under corresponding compliant workflows.”

As an integral part of WuXi AppTec’s integrated CRDMO platform, the Bioanalytical Services team deeply embodies the company’s corporate-wide strategy of Quality by Design (QbD). This philosophy is not merely a slogan, but a core corporate strategy deeply integrated into the operational practices of every global site.From project initiation, stringent quality controls are pre-built into every stage, ensuring processes remain audit-ready at all times.

Under this top-down framework, the Bioanalytical Services team demonstrates agility in adapting to global regulations.For complex cross-region filing needs, the team follows the principle of “One Rule for All”, integrating stringent requirements from the FDA, NMPA, EMA, and other agencies directly into process design.For instance, when a project requires simultaneous regulatory submissions across Asia, North America and Europe, the Bioanalytical Services team can rapidly develop a unified testing framework that aligns with multiple global standards, drawing on the company’s extensive expertise and accumulated experience. This ensures seamless, globally compliant project execution.

Image source: 123RF

This system-wide capability provides clients with greater confidence and predictability.Choosing WuXi AppTec means partnering with a mature quality framework already rigorously vetted by leading global authorities. It not only mitigates risks of repeat experiments due to divergent standards but also significantly reduces timeline uncertainty from audits—acting as a safeguard for the efficiency of clients’ drug development programs.

Meanwhile, frequent global audits in turn fuel the continuous evolution of quality systems. The Bioanalytical Services team treats each inspection as an opportunity to review and optimize workflows, streamlining and enhancing processes based on the latest regulatory expectations. This virtuous cycle of external assessment, reflection and iterative enhancement enables WuXi AppTec to deliver a reassuring, hassle-free experience for clients, achieving robust guarantees for both quality and operational efficiency.

Digital Enabling: Achieving Speed and Stability in Routine Operations

"Fast and reliable"—this is the consistent acclaim WuXi AppTec receives from its clients. At WuXi AppTec, speed and quality are not mutually exclusive.

When asked how the Bioanalytical Services team achieves this balance, Ying shares the team’s approach: “Quality and efficiency are not contradictory. Digitalization, scientific process design, and lean management enable us to uphold quality standards while boosting productivity—making speed and stability our standard model.”

At WuXi AppTec's 2025 Investor Day, the Bioanalytical Services team's digital-driven efficiency initiatives were presented as an example of the company's lean operations:through its digital management platform, WuXi AppTec Bioanalytical Services reduced turnaround times for bottleneck steps by 30% and shortened analytical durations by 35%.

These results are driven by three core digital strategies:

• Real-time visualization of project milestones, breaking down information silos and enabling full progress transparency;

• Automated data flow and audit trails, minimizing manual intervention and human error while ensuring end-to-end data traceability;

• Proactive risk early warning, shifting from a reactive “manual bottleneck detection” model to a system-driven approach that flags risks ahead of time and prevents delays at the source.

As Ying emphasizes: “Our efficiency comes from standardization and digitalization—never from compromising on quality steps.”

Beyond SOPs: Understanding the “Why”

While technological upgrades and system integration are critical, execution ultimately depends on people. WuXi AppTec’s record for high-quality delivery is built on uniformly rigorous quality standards across global sites, implemented consistently to meet both regulatory requirements and client needs. This alignment and execution are fostered through company-wide training, an established quality culture, and ongoing peer learning, knowledge sharing, and collaboration.

Ying notes: “Writing policies or SOPs is straightforward. The real challenge is helping every employee understand why these steps are mandatory.Grasping the rationale behind the system is what matters most.”

Image source: 123RF

Only when teams understand the intent of regulations can they adapt and improve as circumstances evolve. This understanding is not achieved through one-off training, but cultivated through daily mentorship, repeated discussions, and problem-solving—gradually forming internalized discipline and routine behaviors.

This philosophy also defines the new-hire development program. To ensure new staff deliver high-quality work, the Bioanalytical Services team has implemented a rigorous proficiency testing system: new-hires complete simulated assays and mock studies, and must meet all performance benchmarks before independently undertaking client-assigned work.

“New hires are the future of our quality system. We must guard this gateway,” Ying states.

Guided by Science, Illuminating the Path of Innovation

As WuXi AppTec Bioanalytical Services has integrated stringent quality requirements into its daily operational fundamentals, the tide of industry development brings new challenges. The fast-growing development of novel molecular therapies such as new types of peptides, oligonucleotides, and XDC conjugates poses new challenges for bioanalytical science.

Regulations and technical standards for these innovative drug molecules are still evolving, with a few areas remaining in an exploratory phase where no established standards exist. Facing such new challenges, the Bioanalytical Services team adheres to three principles:grounded in scientific rationale, bounded by risk control, and aligned with global regulatory expectations.

“Standards may take time to mature, but scientific logic cannot be compromised,” Ying states. “Even when formal regulations are not yet published, we design rigorous processes based on sound scientific principles.”

One example is a specialized bioanalytical platform at WuXi AppTec Bioanalytical Services, for which no formal bioanalytical method validation or sample analysis guidelines yet exist. Even so, the team proactively established rigorous internal quality standards and well-defined procedures.In a recent first comprehensive regulatory audit of this testing platform, the platform received zero critical findings.

Beyond that, during NMPA audits, the team proactively captures the key focus areas of inspectors and emerging regulatory trends to identify opportunities for optimizing quality management, ensuring the team keeps pace with evolving regulations and pre-emptively strengthens compliance controls.

“Twenty years ago, we were building quality systems. Today, we use these systems to power complex innovation,” Ying reflects. As the industry evolves, the boundaries of bioanalysis continue to expand—from traditional drug testing to novel therapeutic development, from single-stage testing to end-to-end compliance management. Throughout this journey, one thing remains unchanged: the team’s unwavering commitment to quality and respect for science.

The glow of the setting sun falls gently on the focused faces of laboratory scientists. Instruments run steadily, continuously generating authentic and reliable data sets. For the Bioanalytical Services team, every rigorously validated data point contributes to the reliable evidence package that supports the approval of a new medicine, bringing hope and light to patients suffering from disease.

On the long journey of new drug development, bioanalysis serves as a meticulous guardian safeguarding quality throughout the process. Guided by the vision of "every drug can be made, and every disease can be treated", WuXi AppTec Bioanalytical Services team meets every test with composure, adapts to diverse global standards with professional expertise, and upholds uncompromising dedication to every detail.

免責聲明：本文僅作信息交流之目的，文中觀點不代表藥明康德立場，亦不代表藥明康德支持或反對文中觀點。本文也不是治療方案推薦。如需獲得治療方案指導，請前往正規醫院就診。

版權說明：歡迎個人轉發至朋友圈，謝絕媒體或機構未經授權以任何形式轉載至其他平臺。轉載授權請在「藥明康德」微信公眾號回復“轉載”，獲取轉載須知。