药明康德在瑞士库威基地启用商业化规模喷雾干燥车间 | Bilingual|apptec|制剂|恒瑞医药|新药研发|药明康德

近日，药明康德瑞士纳沙泰尔州库威制剂生产基地正式启用全新喷雾干燥车间。药明康德高级副总裁、制剂负责人陈金玲博士，药明康德美欧区总裁Rick Connell博士，药明康德库威基地负责人Jamie Andrews与瑞士纳沙泰尔州瓦尔-德-特拉韦尔市市长Sarah Fuchs-Rota、纳沙泰尔州国务委员兼经济与社会融合部部长Florence Nater共同为车间揭幕。

该车间配备PSD-4喷雾干燥设备，可用于无定形固体分散体生产——该制剂技术能够提升难溶性化合物的口服生物利用度，是破解此类化合物成药难题的重要工艺路径。

▲纳沙泰尔州国务委员兼经济与社会融合部部长Florence Nater，药明康德库威基地负责人Jamie Andrews，瑞士纳沙泰尔州瓦尔-德-特拉韦尔市市长Sarah Fuchs-Rota共同剪彩，Rick Connell博士、Taylor Rauch、陈金玲博士及库威项目团队成员一同出席

进一步完善一体化制剂生产服务布局

库威基地的喷雾干燥能力与基地现有的下游生产环节在同一质量体系下运行，可为客户提供从无定形固体分散体制备到制剂生产的全流程服务。依托药明康德德国慕尼黑基地的欧盟QP（Qualified Person，质量受权人）认证以及批次放行服务，库威基地生产的药品可直接面向欧盟及欧洲经济区市场放行，加速惠及病患。

库威基地PSD-4设备与药明康德泰兴基地现有的喷雾干燥能力共同构成了依托中国及欧洲双地生产的布局及供应链，可为全球客户提供更稳定、灵活的工艺开发与生产解决方案。

陈金玲博士表示：“新药研发管线中近80%的化合物存在水溶性差的问题，制约了其口服成药潜力。通过喷雾干燥分散技术，我们可帮助客户将结晶性化合物转化为稳定的无定形固体分散体，从而提升口服生物利用度。对于患者而言，这一技术可带来更便捷的用药选择。片剂、胶囊等口服剂型可减轻患者频繁往返医院接受注射治疗的负担，让关键药物更快、更便捷地惠及患者。”

持续深耕Val-de-Travers地区，响应客户需求

该喷雾干燥车间是药明康德2021年收购库威基地后持续投入的重点项目之一，截至目前，基地产能已较收购初期实现翻倍。

Rick Connell博士表示：“此次喷雾干燥车间的启用远不止是产能扩容。库威基地是我们欧洲增长战略的核心支柱，这项投入体现了我们对Val-de-Travers地区的长期承诺，也彰显了我们作为瑞士乃至欧洲医药生态系统重要参与者的定位。”

▲药明康德位于瑞士纳沙泰尔州的库威制剂生产基地

关于药明康德库威基地

库威基地自2018年起投入口服固体制剂生产，2021年由药明康德从百时美施贵宝收购。基地已通过美国FDA、瑞士Swissmedic、日本PMDA等全球主要药监机构的质量检查，产品供应覆盖美国、欧洲、日本等全球主要市场。基地采用地热能回收及现场光伏发电系统，其设计曾于2019年获国际制药工程学会（ISPE）年度设施奖（可持续性类别），同时持有ISO 14001环境管理体系及ISO 45001职业健康安全管理体系认证。

WuXi AppTec Opens Commercial-Scale Spray Drying Manufacturing Platform at its Couvet Site in Switzerland

The investment provides WuXi AppTec’s clients with large-scale spray drying manufacturing capability, alongside the site's oral solid dose and packaging operations.

WuXi AppTec, a leading global pharmaceutical CRDMO (Contract Research, Development, and Manufacturing Organization), announces the opening of a new spray drying facility at its drug product manufacturing site in Couvet, Neuchâtel, Switzerland. Dr. Jinling Chen, Senior Vice President, Head of Drug Product at WuXi AppTec, Dr. Rick Connell, President US & Europe, WuXi AppTec, Jamie Andrews, Site Head and General Manager, inaugurated the building with Sarah Fuchs-Rota, Présidente of the Commune de Val-de-Travers, and Florence Nater, State Councillor and Head of the Department of Economy and Social Cohesion for the Canton of Neuchâtel.

The facility houses a PSD-4 spray dryer for manufacturing amorphous solid dispersions, a formulation approach that increases the oral bioavailability of poorly water-soluble compounds.

▲From left: Florence Nater, State Councillor for the Canton of Neuchâtel, Jamie Andrews, Site Head and General Manager of the Couvet site, and Sarah Fuchs-Rota, Présidente of the Commune de Val-de-Travers, cut the ribbon, joined by Dr. Rick Connell, Taylor Rauch, Dr. Jinling Chen and members of the Couvet project team

What the platform gives

Spray drying at Couvet sites alongside the downstream operations the site already runs, providing WuXi AppTec’s clients with access to amorphous solid dispersion technology and the finished dosage form under one quality system in one location. Drug products manufactured there can be released for the EU and EEA through WuXi AppTec's Qualified Person and batch release services in Munich, Germany, helping accelerate patient access to critical therapies.

Couvet's PSD-4 also complements the existing spray drying capability at WuXi AppTec’s China facilities, allowing spray drying processes to be run both in Europe and in China.

Dr. Jinling Chen said the capability addresses a constraint that affects a large share of molecules in development. “Nearly 80% of compounds in the drug discovery pipeline suffer from poor water solubility, limiting their potential as oral medicines. By providing spray-dried dispersion technology, our clients can unlock these compounds by transforming the crystalline drug into a stable amorphous solid dispersion, improving oral bioavailability. For patients, this can mean a dosage form that is easier to take. Oral medicines, such as tablets and capsules, can reduce the burden on patients facing lengthy trips to hospitals for injections, getting vital medicines to patients faster and easier”

Continuing investment in the Val-de-Travers region and customer needs

The spray drying facility continues a program of investment that began when WuXi AppTec acquired the Couvet site in 2021. Manufacturing capacity at the site has since doubled.

“This is far more than a ribbon-cutting. Couvet is a central pillar in our broader European growth strategy, and this investment reflects our deep commitment to the Val-de-Travers region and our role as a dedicated anchor of the pharmaceutical ecosystem here in Switzerland and across Europe,” said Dr. Rick Connell.

About the WuXi AppTec Couvet site

The site has manufactured oral solid dosage forms since 2018 and has been part of WuXi AppTec since it was acquired from Bristol Myers Squibb in 2021. It has been inspected by the U.S. FDA, Swissmedic, and Japan's PMDA, and supplies products worldwide, including to the U.S., Europe, and Japan. The facility incorporates geothermal energy recovery and on-site photovoltaic generation. It is part of a design that received the ISPE Facility of the Year Award for Sustainability in 2019. The site also holds ISO 14001 and ISO 45001 certifications.