编者按：“让天下没有难做的药，难治的病”，是初心，更是愿景。自成立以来，药明康德步履不停：从一间实验室，到覆盖亚洲、欧洲和北美的全球网络。从早期的化学合成服务，到贯穿研究（R）、开发（D）和生产（M）的一体化平台。从第一位客户，到全球三十多个国家的众多合作伙伴。不断发展的，是规模与能力；始终坚守的，是梦想与承诺。本系列文章将立足药明康德一体化CRDMO平台，系统讲述公司不断深化的能力和规模体系，以平台承载信任，持续赋能客户创新，共同推动更多突破性疗法走向病患。
2026年初的一个清晨，阳光透过洁净明亮的玻璃窗，洒落在药明康德测试事业部上海生物分析部实验室里。精密的仪器泛着温润而沉静的光泽，研究员们已各就各位，一切井然有序。与往常不同的是，这一天，实验室迎来了两位特殊的“客人”——美国病理学家协会（CAP）的现场审计官。
实验室的研究员们并没有因审计官的到来而打乱步调，他们熟练地调试仪器、整理试剂，电脑屏幕上跳动着项目进度表，一切如常。
审计官们有条不紊地穿梭在各个实验台之间，翻看记录、询问操作、抽查数据，全程没有一句多余的话语。随着各项检查的推进，他们原本紧绷的神情渐渐舒展，最终浮现出满意的笑容。
当审计官合上文件的那一刻，结果没有意外：无严重发现项，顺利完成审计。
审计不是考验，是质量的“全面体检”
此次完成CAP审计并非偶然。自2005年药明康德生物分析部成立以来，实验室已多次通过中国国家药品监督管理局（NMPA，原CFDA）、美国食品药品监督管理局（FDA）、经济合作与发展组织（OECD）、欧洲药品管理局（EMA）、美国病理学家协会（CAP）、日本医药品医疗器械综合机构（PMDA）的体系和项目核查。这些成果，是团队多年来深耕“高标准质量体系”的有力见证。
图片来源：123RF
当被问及为何能每一次都高质量完成全球权威机构的审计时，药明康德测试事业部生物分析部中国区负责人童莹女士给出的回答简洁而坚定：“我们强调‘any time is ready’（随时准备着）。”
在日常工作时，生物分析团队始终在思考一个问题：今天完成的每一个项目，是否都能经得起未来任何一次审计的检验？秉持这一理念，团队在质量体系设计之初就已将数据可靠性、可追溯性以及合规要求前置，并融入到日常工作的每一个环节。
在童莹看来，审计官是来帮团队做“体检”的——既能核验现有质量体系与项目执行的合规性，更能识别潜在的改进空间。因此，生物分析团队一直以来都是以积极开放的心态欢迎每一次审计的到来。
这份从容，源于生物分析团队对细节的极致坚守。在行业惯例或法规未作强制要求的环节，生物分析团队依然精益求精。以关键数据复核为例，即便部分步骤未强制要求双人复核，团队仍主动设置该流程，牢牢守住数据准确性的底线。
正是这份对细微之处也一丝不苟的坚持，赢得了审计机构的高度认可。在数次OECD审计中，审计组对生物分析部成熟的GLP体系建设与高标准质量给予了高度评价，认为其在质量体系、文件管理、数据记录与归档等方面持续精进，尤其认可计算机化系统验证方面的规范性、SOP的合规性，以及记录的透明性与可追溯性。
“只要把每一个细节坚守到位，监管机构与客户的满意，自然水到渠成。”童莹补充道。
这种对质量的坚守，也是整个药明康德质量体系的缩影。2025年，药明康德全年接受各类质量审计和检查共计741次，包括680次客户审计，56次监管机构检查，以及5次独立第三方审计，所有审计保持“无严重发现项”。
以“质量源于设计”，适配全球监管需求
从创立伊始，药明康德就严格遵循全球高标准。面对来自不同国家和地区监管机构以及专业认证组织的多元要求，生物分析部的核心竞争力之一，就在于能够实现“多标并行、无缝适配”。
“不同机构的审计关注点不同。”童莹解释道，“有些机构强调数据完整性与临床数据科学可靠性，有些则强调研究全过程的体系化，也有机构更关注临床检测实验室的质量控制与持续改进。我们的质量体系能够确保所有项目都可在相应的合规流程下运行。”
作为药明康德一体化CRDMO平台的重要组成部分，生物分析部始终贯彻公司推行的“质量源于设计（Quality by Design）”理念。这一理念并非仅停留在口号上，而是作为公司层面的核心战略，深深植根于全球每一个基地的运营实践中。从项目启动的源头开始，高标准的质量控制就被预先植入到每一个环节，确保整个流程经得起随时随地的检验。
在这一顶层设计的指引下，生物分析团队展现出全球法规适配能力。面对复杂的跨地区申报需求，团队坚持“一套规则，全球通行（One Rule for All）”的原则，将FDA、NMPA、EMA等不同监管机构的严格要求，前置融入到流程设计中。例如，当一个项目需要同时在亚洲、北美，以及欧洲多地申报时，生物分析团队能够基于公司深厚的积淀，迅速整合出一套兼顾多方标准的检测方案，确保项目在全球范围内合规推进。
图片来源：123RF
这种源自公司层面的体系优势，能够为客户提供可靠的确定性。选择药明康德，意味着选择了一个已经完成全球多家权威机构严格审查的成熟质量体系。这不仅有效规避了因标准差异导致需补充实验的风险，更大幅降低了审计带来的时间不确定性，为客户的新药研发项目保驾护航。
同时，高频次的全球审计也反哺了质量体系的进化。生物分析团队将每一次审计视为复盘与优化的契机，通过洞悉全球监管的最新趋势，不断对流程进行“优化”与“强化”。这种“接受检验-复盘优化”的正向循环，使得团队能够持续为客户提供“安心省力”的交付体验，真正实现了质量与效率的双重保障。
数字化赋能，让“又快又稳”成为常态
“又快又稳”是客户对药明康德的一致赞誉。在药明康德，速度与质量从来不会被取舍。
谈及生物分析团队如何实现“又快又稳”，童莹给出了团队的解题思路：“质量与效率并不矛盾。以数字化为支撑，做好科学的流程设计和精细化管理，就能在严守质量底线的同时实现效率跃升，让‘又快又稳’成为常态。”
在药明康德2025年的投资者日上，生物分析团队的数字化提效实践作为公司精益运营的成果之一得到了展示。数据显示，依托数字化管理平台，团队将瓶颈环节的周转时长降低30%，分析时长降低35%。
这背后是三项核心数字化举措的落地：一是项目节点可视化，打破信息壁垒，让团队实时掌握项目进度；二是自动化数据流转与审计追踪，减少人工干预，降低人为误差，实现数据全程可追溯；三是风险预警提前介入，将过去“人工发现瓶颈”的被动模式，转变为“系统提前提示风险”的主动模式，从源头规避延误。
正如童莹女士所强调的：“我们的效率来自标准化和数字化，绝不是靠压缩质量步骤来换取的。”
比SOP更重要的，是“为什么这么做”
技术升级与系统打通固然关键，但最终仍需人来落地执行。在业内，“高质量交付”早已成为药明康德的一张名片，其背后，是全球各基地始终保持一致的质量标准与高效的执行能力——既能精准契合全球监管机构的各项法规要求，也能全方位满足全球客户的核心需求。这份一致性与执行力，除了依托自上而下的统一培训、筑牢全员质量认知，更离不开团队常态化的相互学习、经验传承与交流共进。
童莹坦言：“写制度或SOP并不难，难的是让每一位员工真正理解‘为什么必须这样做’。理解体系背后的逻辑，才是核心。”
图片来源：123RF
只有深刻理解制度设立的初衷，才能在环境变化时知道如何迭代优化。这种理解并非单次培训就能达成，而是在生物分析团队日常带教、反复研讨和问题复盘过程中，逐步沉淀为团队共识与行为自觉。
这一理念同样贯穿于新员工培养体系。为确保新员工上岗后操作稳健、合规，团队建立了严格的熟练度测试机制：通过模拟测试与模拟项目进行实操演练，各项指标全部达标后，方能独立承接客户项目。
“新员工是质量体系的未来，我们必须守住这个入口。”童莹补充道。
以科学为灯，照亮创新之路
当药明康德生物分析团队把高标准质量内化为基本功时，行业发展的浪潮也带来了新的考验——新型多肽药物、寡核苷酸药物、XDC偶联药物等新分子疗法的加速兴起，对生物分析领域提出了一道新的时代课题。
这些创新药物分子的相关法规与技术标准仍在完善，个别领域甚至处于“无现成标准可依”的探索阶段。面对新的考验，团队牢牢把握三个原则：以科学原理为核心、以风险控制为底线、以全球监管趋势为参照。
“标准可以慢慢完善，但科学逻辑不能模糊。”童莹说，“有时监管标准尚未出台，但我们必须基于科学原理，设计出严谨的流程。”
以一个特色生物检测平台为例，目前尚未有正式的生物分析方法验证和样品分析技术指导原则，但团队早已从严要求，提前建立了严格的流程和内部标准。在最近完成的一次监管部门首次对该检测平台项目的全面审计中，实现了“无严重发现项”。
此外，在多次NMPA审计过程中，团队主动关注核查专家的关注重点与行业监管趋势，发掘质量管理的优化方向，始终确保团队与法规步调一致，提前布局合规管控。
“二十年前，我们在搭建质量体系；今天，我们在用体系支持复杂创新。”童莹不禁感慨道。随着行业发展，生物分析的边界在不断拓展，从传统药物检测到新型疗法研发，从单一环节检测到全流程合规管控，唯一不变的，是团队对质量的极致坚守与对科学的敬畏。
夕阳余晖洒在实验员们专注的脸庞上。仪器平稳运转，一组组真实、可靠的数据持续生成。对他们而言，每一组严谨无误的数据，都可能成为一款新药成功获批、惠及病患的关键支持。
在新药研发的漫长征程中，生物分析是确保质量的“较真”的守护者。药明康德生物分析团队，以从容姿态应对每一次检验，以专业能力适配多元标准，以对细节的极致坚守，切实践行着公司“让天下没有难做的药，难治的病”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.
免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。
版权说明：欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。
热门跟贴