藥明康德圣地亞哥基地開放日：一站式連接生物學與化學能力

新藥研發是個一體化的過程。想要開發新藥，我們既需要在科學上有所突破，也需要具備高通量的分子篩選能力、精準的實驗和分析方法、前沿的制劑技術以及大規模的生產能力。不同的環節之間銜接越緊密，研發項目就能推進得越高效。

在藥明康德近期舉辦的圣地亞哥基地開放日上，來自產業的創新者就得以在近距離了解這種一體化的研發平臺。通過在同一基地內連接生物學和化學能力，圣地亞哥基地能幫助合作伙伴以更快的速度推進項目。

一體化的生物學平臺：提供關鍵早期決策

對于新藥研發項目來說，早期的科學判斷，往往會直接影響一個分子后續能走得多快、走得多穩。靶點生物學是否清晰，實驗方法是否可靠，能否找到有潛力的苗頭化合物，體內模型是否合適，以及是否提前考慮了后續的轉化策略，共同決定了一個臨床前項目的推進效率。

在圣地亞哥基地，藥明康德正是通過一體化的生物學平臺，助力合作伙伴將項目高效地從靶點發現逐步推進到候選分子篩選。該基地的100多名科學家覆蓋靶點發現、苗頭化合物發現、從苗頭到先導、先導化合物優化、臨床前研究以及IND申報準備等關鍵環節，為合作伙伴提供支持。

藥明康德生物學平臺的重要優勢之一，是能夠圍繞不同疾病領域提供端到端的支持。以免疫學平臺為例，團隊在先天免疫和適應性免疫反應方面積累了豐富經驗。這種對疾病生物學機制的深度理解能更好地為合作伙伴的項目保駕護航。

與此同時，圣地亞哥基地的體內藥理學能力也能進一步在臨床前療效評估階段提供支持。在腫瘤、中樞神經系統疾病、纖維化疾病、代謝疾病、炎癥和自身免疫疾病等領域，該團隊提供的疾病模型已經在大量的研發項目中得到了驗證，從而可以幫助合作伙伴在更具生物相關性的系統中進行評估，做出關鍵開發決策，為項目后續推進提供更扎實的依據。

從生物學到化學：連接新藥發現和早期臨床開發

如果說生物學平臺為從靶點發現到候選分子篩選的早期階段提供了賦能，那么同樣位于藥明康德圣地亞哥基地的化學平臺則能進一步將這種賦能延伸至早期臨床開發階段。

具體來看，藥明康德一體化的化學能力平臺涵蓋API、制劑、分析和臨床供應支持等服務。該基地可以靈活地支持早期cGMP生產，通過與生物學平臺在同一基地內協同布局，團隊能將早期分子設計與優化，與API生產和制劑開發等實際需求更緊密地連接起來，助力客戶項目更高效地跨越關鍵轉化節點，縮短IND時間線，并降低運營風險。制劑能力進一步增強了該基地對早期臨床開發的支持。圣地亞哥基地具備粉末灌裝膠囊生產技術，其設備能滿足多種實際需求。

跑贏時間：5個月進入IND階段

對于早期研發項目，時間線越緊迫，一體化研發平臺的價值就越清晰。在圣地亞哥基地的開放日活動中，我們也看到了一個具體案例：一家位于美國的生物技術公司急需準備1期臨床開發的物料，但時間相當緊急。他們找到藥明康德，尋求加速生產支持。

藥明康德的解決方案，是平行啟動API的生產與分析。項目首先啟動GMP API生產與放行，并在10周內完成。在此期間，API和制劑的分析方法開發與驗證同步推進，而不是作為后續環節處理。這種并行推進方式幫助加快了后續放行步驟，并降低了時間線延誤的風險。

API準備就緒后，團隊隨即進入臨床試驗物料生產與放行階段。在六周內，藥明康德完成了兩種劑量規格、共7000粒膠囊的生產。這能讓制劑工作在API放行后直接推進，而無需在多個外部基地之間轉移物料或方法。

在臨床物料生產完成后，項目繼續進行為期一個月的穩定性研究，最終在五個月內支持項目達到IND準備狀態。

為新藥研發提供確定性

在圣地亞哥基地的開放日活動中，藥明康德向來賓們展示了一體化平臺能如何改變早期項目的推進方式。在傳統模型中，早期的靶點驗證、分子篩選、從苗頭化合物到先導化合物的優化、臨床前研究、IND申報，再到API生產，制劑策略、分析方法、以及質量控制，往往分散在不同的供應商，不同的基地之間。項目因此可能面臨更多交接，因此周期可能更長，運營風險也可能更高。

在藥明康德，當生物學平臺的藥物發現能力與化學平臺的早期臨床開發能力無縫結合，就能幫助全球創新合作伙伴降低研發的復雜性，從而更快做出決策，高效邁向IND和早期臨床開發，最終造福全球病患。

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.

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。