药明康德圣地亚哥基地开放日：一站式连接生物学与化学能力

新药研发是个一体化的过程。想要开发新药，我们既需要在科学上有所突破，也需要具备高通量的分子筛选能力、精准的实验和分析方法、前沿的制剂技术以及大规模的生产能力。不同的环节之间衔接越紧密，研发项目就能推进得越高效。

在药明康德近期举办的圣地亚哥基地开放日上，来自产业的创新者就得以在近距离了解这种一体化的研发平台。通过在同一基地内连接生物学和化学能力，圣地亚哥基地能帮助合作伙伴以更快的速度推进项目。

一体化的生物学平台：提供关键早期决策

对于新药研发项目来说，早期的科学判断，往往会直接影响一个分子后续能走得多快、走得多稳。靶点生物学是否清晰，实验方法是否可靠，能否找到有潜力的苗头化合物，体内模型是否合适，以及是否提前考虑了后续的转化策略，共同决定了一个临床前项目的推进效率。

在圣地亚哥基地，药明康德正是通过一体化的生物学平台，助力合作伙伴将项目高效地从靶点发现逐步推进到候选分子筛选。该基地的100多名科学家覆盖靶点发现、苗头化合物发现、从苗头到先导、先导化合物优化、临床前研究以及IND申报准备等关键环节，为合作伙伴提供支持。

药明康德生物学平台的重要优势之一，是能够围绕不同疾病领域提供端到端的支持。以免疫学平台为例，团队在先天免疫和适应性免疫反应方面积累了丰富经验。这种对疾病生物学机制的深度理解能更好地为合作伙伴的项目保驾护航。

与此同时，圣地亚哥基地的体内药理学能力也能进一步在临床前疗效评估阶段提供支持。在肿瘤、中枢神经系统疾病、纤维化疾病、代谢疾病、炎症和自身免疫疾病等领域，该团队提供的疾病模型已经在大量的研发项目中得到了验证，从而可以帮助合作伙伴在更具生物相关性的系统中进行评估，做出关键开发决策，为项目后续推进提供更扎实的依据。

从生物学到化学：连接新药发现和早期临床开发

如果说生物学平台为从靶点发现到候选分子筛选的早期阶段提供了赋能，那么同样位于药明康德圣地亚哥基地的化学平台则能进一步将这种赋能延伸至早期临床开发阶段。

具体来看，药明康德一体化的化学能力平台涵盖API、制剂、分析和临床供应支持等服务。该基地可以灵活地支持早期cGMP生产，通过与生物学平台在同一基地内协同布局，团队能将早期分子设计与优化，与API生产和制剂开发等实际需求更紧密地连接起来，助力客户项目更高效地跨越关键转化节点，缩短IND时间线，并降低运营风险。制剂能力进一步增强了该基地对早期临床开发的支持。圣地亚哥基地具备粉末灌装胶囊生产技术，其设备能满足多种实际需求。

跑赢时间：5个月进入IND阶段

对于早期研发项目，时间线越紧迫，一体化研发平台的价值就越清晰。在圣地亚哥基地的开放日活动中，我们也看到了一个具体案例：一家位于美国的生物技术公司急需准备1期临床开发的物料，但时间相当紧急。他们找到药明康德，寻求加速生产支持。

药明康德的解决方案，是平行启动API的生产与分析。项目首先启动GMP API生产与放行，并在10周内完成。在此期间，API和制剂的分析方法开发与验证同步推进，而不是作为后续环节处理。这种并行推进方式帮助加快了后续放行步骤，并降低了时间线延误的风险。

API准备就绪后，团队随即进入临床试验物料生产与放行阶段。在六周内，药明康德完成了两种剂量规格、共7000粒胶囊的生产。这能让制剂工作在API放行后直接推进，而无需在多个外部基地之间转移物料或方法。

在临床物料生产完成后，项目继续进行为期一个月的稳定性研究，最终在五个月内支持项目达到IND准备状态。

为新药研发提供确定性

在圣地亚哥基地的开放日活动中，药明康德向来宾们展示了一体化平台能如何改变早期项目的推进方式。在传统模型中，早期的靶点验证、分子筛选、从苗头化合物到先导化合物的优化、临床前研究、IND申报，再到API生产，制剂策略、分析方法、以及质量控制，往往分散在不同的供应商，不同的基地之间。项目因此可能面临更多交接，因此周期可能更长，运营风险也可能更高。

在药明康德，当生物学平台的药物发现能力与化学平台的早期临床开发能力无缝结合，就能帮助全球创新合作伙伴降低研发的复杂性，从而更快做出决策，高效迈向IND和早期临床开发，最终造福全球病患。

From Discovery to the Clinic: How WuXi AppTec’s San Diego Site Connects Biology and Chemistry

Drug discovery does not move forward through isolated steps. A promising biological insight must be translated into validated assays, high-quality starting points, optimized molecules, preclinical evidence, manufacturable API, suitable formulation, analytical methods, and clinical-ready material. The faster these elements can be connected, the more efficiently an early-stage program can advance.

Last month, an open house at WuXi AppTec’s San Diego site offered a closer look at how this connection can work in practice.With Biology and Chemistry capabilities co-located, the site supports a more integrated path from discovery research to IND and early clinical development.Rather than focusing only on individual capabilities, the San Diego platform reflects a broader model: bringing scientific insight, operational execution, and development readiness closer together to help partners move programs forward with greater speed and confidence.

WuXi Biology as a Local Gateway to Integrated Drug Development

For drug discovery programs, early scientific decisions often determine how efficiently a molecule can move forward. Target biology, assay design, hit identification, in vivo model selection, and translational strategy are connected decisions that shape the quality and confidence of a preclinical program.

At WuXi AppTec’s San Diego site, the Biology team supports this early discovery continuum through an integrated biology platform designed to help partners advance programs from target discovery through candidate selection.With more than 100 scientists, the site provides discovery and research support across key stages, including target discovery, hit finding, hit-to-lead, lead optimization, preclinical research, and IND-enabling preparation.

A key strength of the site is its end-to-end biology support across disease areas. For example, its immunology team has extensive experience in both innate and adaptive immune responses, supporting programs that require deep disease biology and relevant translational models. The immunology platform has successfully supported multiple preclinical programs, ranging from molecular glues to T-cell engagers for autoimmune diseases, helping them reach key milestones such as global collaborations and acquisitions.

The site’s in vivo pharmacology capabilities further extend this support into preclinical efficacy testing. Validated disease models in oncology, central nervous system disorders, fibrosis, metabolism, inflammation, and autoimmune diseases help partners evaluate therapeutic concepts in biologically relevant systems before advancing toward development decisions.

Connecting Discovery with Early Clinical Development Through Chemistry

While the Biology team supports the early scientific path from target discovery to candidate selection, the San Diego site Chemistry staff extends that support into early-phase clinical development.

With discovery biology and early-phase chemistry support available at a single site, client programs move more efficiently across critical transition points without repeated multi-site transfers.This setup can help reduce timelines to IND, lower operational risk, and control cost by improving coordination across scientific, analytical, formulation, and supply-related activities.

In San Diego, integrated early-phase clinical development services cover API, formulation, analytical, and clinical supply support, supporting cGMP manufacturing with great flexibility. This allows teams to connect early molecule design and optimization with the practical requirements of producing, characterizing, formulating, and supplying material for early clinical studies.

For API production, the site is equipped to support flexible cGMP manufacturing at early clinical scale. The range of capabilities provides flexibility for different chemistries, scales, and development needs.

Formulation capabilities further strengthen the site’s early clinical development support. The San Diego site offers powder-in-capsule production capability that can provide a practical and efficient formulation path when speed, material efficiency, and flexibility are especially important.

Integrated API and Drug Product Manufacturing for Phase I in Five Months

The value of an integrated early-phase development platform becomes especially clear when a program faces compressed timelines.In one case, a U.S. biotech company needed expedited manufacturing support to prepare for Phase I clinical development. The project required not only GMP API production, but also drug product manufacturing, analytical development, release testing, and stability support within a tightly coordinated timeline.

WuXi AppTec’s solution was to integrate API and drug product manufacturing within the same building.The project began with GMP API manufacturing and release, which was completed within 10 weeks. During this period, analytical method development and validation for both API and drug product were advanced in parallel, rather than treated as downstream activities. This parallel execution helped accelerate later release steps and reduced the risk of timeline delays.

Once the API was ready, the team moved into clinical trial material manufacturing and release. Within 6 weeks, WuXi AppTec produced 7,000 capsules in two dosage strengths. The workflow allowed drug product activities to follow directly from API release without the added complexity of transferring materials, methods, or documentation across multiple external sites.

After completion of clinical material manufacturing, the program proceeded through a one-month stability test, supporting IND readiness within 5 months.

For early-stage biotech companies, this type of support can be particularly important. Phase I preparation often requires rapid execution with limited material, limited time, and evolving development needs.By connecting API manufacturing, formulation, analytical development, clinical supply, and quality oversight within one coordinated platform, WuXi AppTec helped reduce complexity and support a faster path toward IND readiness.

A More Connected Path from Discovery to the Clinic

The San Diego site shows how integration can change the way early-stage programs move forward. When on-site biology discovery capabilities are combined with chemistry early-phase clinical development services, the platform provides a more connected path from biological insight to clinical-ready material.

This connection matters because the transition from discovery research into IND-enabling and early clinical stages is often where programs encounter friction. Scientific decisions, API supply, formulation strategy, analytical methods, quality requirements, and clinical material timelines all need to come together. When these activities are fragmented across multiple sites or partners, programs may face added handoffs, longer timelines, and higher operational risk.

The broader significance of the San Diego site is therefore not only its individual technical capabilities, but the way those capabilities are organized. By bringing discovery biology, API manufacturing, formulation, analytical support, and early clinical supply closer together, the site is designed to help innovators make faster decisions, reduce unnecessary transfers, and move more efficiently toward IND and early clinical development.

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