媒體聲音 | 藥明康德一體化CRDMO如何助力歐洲創新發展

金秋十月，被譽為全球制藥行業“風向標”的CPHI（世界制藥原料展覽會）在德國法蘭克福拉開帷幕。在分子復雜性增加與監管趨嚴的雙重挑戰下，如何加速藥物開發進程、推動創新轉化，成為各方關注的核心議題。

面對行業共性挑戰，藥明康德的戰略明確：通過一體化的CRDMO平臺，實現從藥物研究（R）、開發（D）到生產（M）的全流程無縫賦能，助力客戶推動更多創新療法早日問世，造福全球病患。

近日，藥明康德高級副總裁，小分子原料藥后期和商業化項目業務部負責人陳珂博士接受了德國行業媒體CHEManager的專訪。陳珂博士在有機合成化學、原料藥工藝研發與生產以及新藥CMC等領域擁有十多年的行業經驗。她分享了自己對于行業發展和區域創新的洞見，并介紹了像藥明康德這樣的全球合作伙伴如何賦能歐洲乃至全球客戶，推動創新生態圈的發展。

以下是報道全文，點擊“閱讀原文/Read More”即可訪問原文頁面。

從德國、瑞士，到全球聯動

藥明康德在歐洲設有兩個運營基地。其中，慕尼黑基地是藥明康德全球CRDMO網絡中專注于研究（R）的關鍵節點，在早期藥物發現領域深耕近20年，為客戶提供結構解析、蛋白質科學、生物物理分析等服務。“慕尼黑團隊科研實力雄厚，能夠快速、有效地表征靶標蛋白，并基于結構優化藥物，賦能全球客戶加速早期研發。”陳珂博士解釋道。

▲圖片來源：藥明康德慕尼黑基地

同時，藥明康德持續加大對瑞士庫威基地的投資。該基地專注于制劑生產和包裝，致力于為后期臨床和商業化規模生產（M）提供靈活高效的服務。陳珂博士指出，慕尼黑基地的早期發現專長與庫威基地的生產能力形成互補，是藥明康德各業務板塊相互協同的生動體現。“通過資源整合和一體化服務網絡，藥明康德能夠為歐洲生物技術企業提供全面的研發和生產服務，共同加強區域生態圈的創新活力。”

▲藥明康德瑞士庫威基地

一體化平臺賦能區域創新

目前，藥明康德的活躍客戶數約6000家，涵蓋初創企業及包括全球排名前20的大型醫藥公司。

藥明康德獨特的一體化CRDMO平臺能夠賦能新藥從早期發現、開發到生產的全流程，為藥物開發的各個階段提供解決方案。以CMC（化學、生產與控制）為例，CMC在藥物研發中扮演著至關重要的角色，尤其當創新藥開發到了臨床后期階段，CMC工作通常聚焦于可放大的工藝、好的質量研究、清晰的質量目標，以及一體化解決方案等方面，但無論是原料藥、制劑、分析，乃至資料撰寫，各個環節都頗具挑戰。“CMC不應成為新藥研發進程的瓶頸。”陳珂博士強調，“我們的目標是保障各個研發環節順利推進，幫助客戶加速項目進程，并滿足監管要求。”

對于新興生物科技公司而言，與CRDMO合作的價值尤為顯著。“這些公司通常規模小、資源有限。我們的CRDMO平臺能夠提供豐富的項目管理經驗和CMC專業知識，幫助其高效、快速地推進研發，更好地吸引投資。”陳珂博士解釋道，“我們可以根據客戶的不同需求，組建專屬服務團隊，提供從臨床前到商業化生產的一體化解決方案，確保高效、靈活和高質量的服務。”

展望未來

談及行業未來挑戰，陳珂博士表示：“隨著靶向蛋白降解劑（TPD）、多肽、寡核苷酸等新分子涌現，藥物分子日益復雜。為此，我們持續在制劑開發生產、原料藥工藝開發等領域夯實能力建設，熟知并恪守歐洲法律法規，更好地為當地及全球客戶賦能。”

歐洲是藥明康德重要的戰略發展區域。“歐洲憑借卓越的基礎研究、眾多活躍的生物技術公司以及不斷增長的投資規模，展現出強大的創新活力。”陳珂博士說，“我們的使命是幫助歐洲乃至全球客戶加速新藥臨床開發和獲批進程，為有需要的患者帶來更多突破性療法。”

WuXi AppTec: A Partner for Innovation

When the pharmaceutical and biotech industry gathers in Frankfurt for CPHI in October, discussions focus on key topics: increasing molecular complexity, rising regulatory demands, and the pressure to shorten development timelines. For WuXi AppTec, one thing is clear: integrated development and manufacturing approaches accelerate the path to patients. WuXi AppTec offers clients a seamless connection between research, development, and production.

In a recent interview with CHEManager, Dr. Ke Chen, Senior Vice President and Head of API Late Phase Development and Commercialization at WuXi AppTec, shares how WuXi AppTec is strengthening its presence in Europe and enabling global innovation through local excellence.

From Munich to Couvet and Beyond

A key part of this strategy is WuXi AppTec’s subsidiary Crelux in Munich, which has specialized in early drug discovery for nearly 20 years, focusing on structural biology, protein biochemistry, and biophysics. “In Munich, we provide the scientific depth needed to characterize target proteins and directly use structures for drug optimization,” explains Chen.

At the Swiss site in Couvet, WuXi AppTec works on late-stage development and commercial production. “The combination of Munich’s research and Switzerland’s manufacturing strength is a good example of our global network, which offers European clients access to comprehensive resources,” says Chen.

A Global Model – Locally Anchored

With around 6,000 active clients worldwide — from top 20 pharmaceutical companies to startups, biotechs, and research institutions — WuXi AppTec operates as a Contract Research, Development, and Manufacturing Organization (CRDMO), integrating research, development, and production.

“CMC must not become a bottleneck in development,” says Chen. “Our goal is to ensure development steps run smoothly and projects advance efficiently and in compliance with regulatory requirements.”

This is especially crucial for young biotech companies. “Many biotech firms operate with small teams and limited budgets. We support them with project management experience and CMC expertise so they can advance their development goals faster and attract investors,” explains Chen. “WuXi AppTec provides tailored teams and flexible service packages precisely aligned with each project phase — from early development to clinical manufacturing and commercial production.”

Future Outlook

Chen sees the challenges of the coming years clearly: “We’re witnessing increasing molecular complexity — from chimeric molecules for targeted protein degradation (Proteolysis Targeting Chimeras, PROTACs) to peptides and oligonucleotides.”

WuXi AppTec is aligning its strategy accordingly. “We’re consistently expanding our expertise with advanced formulation and process solutions, and with teams that are well-versed in European regulatory requirements,” says Chen.

Europe remains a growth market for WuXi AppTec. “Here, excellent basic research, dynamic biotech companies, and investor interest come together. Our goal is to bring these innovations to the clinic and market approval faster — giving patients earlier access to new therapies.

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