WuXi STA https://sta.wuxiapptec.com Tue, 01 Jul 2025 10:31:34 +0000 en-US hourly 1 https://wordpress.org/?v=6.8.3 https://sta.wuxiapptec.com/wp-content/uploads/2023/09/favicon-1-150x150.png WuXi STA https://sta.wuxiapptec.com 32 32 WuXi STA launched a new PSD-4 spray dryer at our Taixing API manufacturing facility in China https://sta.wuxiapptec.com/wuxi-sta-launched-a-new-psd-4-spray-dryer-at-our-taixing-api-manufacturing-facility-in-china/ Tue, 01 Jul 2025 10:30:45 +0000 https://sta.wuxiapptec.com/?p=29489 WuXi STA continues to expand spray-dried dispersion (SDD) capabilities with the launch of a new PSD-4 spray dryer at our Taixing API manufacturing facility in China, further increasing our commercial spray drying manufacturing capacity.

With a full suite of spray dryers, our SDD platform supports production from mg scale to metric tons, enabling faster scale-up across development stages to meet your specific needs, without compromising quality.

Whether you’re racing toward IND or preparing for commercial launch, we deliver the expertise, speed, flexibility, and flawless execution to move your program forward, faster with confidence.

PSD-4 spray dryer at our Taixing API manufacturing facility in China
PSD-4 Spray Dryer
]]>
WuXi AppTec’s Changzhou and Taixing API Sites Successfully Pass FDA Inspections https://sta.wuxiapptec.com/wuxi-apptecs-changzhou-and-taixing-api-sites-successfully-pass-fda-inspections/ Tue, 01 Apr 2025 02:29:06 +0000 https://sta.wuxiapptec.com/?p=28899 WuXi AppTec’s Changzhou and Taixing API Sites Successfully Pass FDA Inspections Read More »

]]>
Shanghai, ChinaApril 1, 2025 — WuXi AppTec, a global company that provides a broad portfolio of R&D and manufacturing services to enable companies in the pharmaceutical and life sciences industry, today announced that its Active Pharmaceutical Ingredient (API) manufacturing sites at Changzhou and Taixing in Jiangsu province of China, successfully passed U.S. Food and Drug Administration (FDA) inspections back-to-back in March — both without a single observation and with no Form 483 issued. These achievements further demonstrate WuXi AppTec’s unwavering commitment to upholding the highest quality standards and to supporting global healthcare innovators in reliably delivering needed therapies to patients worldwide.

The Company’s API site at Changzhou underwent a GMP surveillance inspection by the FDA that began on March 4. Covering 21 FDA-approved products, the inspection followed the FDA’s six-system inspection model. The FDA inspectors concluded the review one day ahead of schedule. No observation was raised.

On March 21, 2025, the API site at Taixing also completed a Pre-Approval Inspection (PAI) for the commercial manufacturing of a peptide-based therapeutic, with no observation. The site presented its state-of-the-art infrastructure, the team’s strong technical expertise, and the high level of compliance demonstrated through its systems, documentation, and records. Operational since September 2023, the 169-acre Taixing site is the company’s newest and largest API manufacturing facility. The successful inspection confirms the site’s readiness to support commercial API supply to the global market.

“Our team’s consistent focus on quality and compliance is key to enabling our global partners,” said Dr. Minzhang Chen, Co-CEO of WuXi AppTec. “We’re pleased that both the Changzhou and Taixing sites passed their FDA inspections with no observation. These successful results further reinforce WuXi AppTec’s dedication to providing high-quality R&D and manufacturing solutions that support our customers worldwide in accelerating new drug development and commercialization for the benefit of patients.”

The Changzhou and Taixing sites are critical manufacturing bases of WuXi STA, the company’s small molecule CDMO platform, and WuXi TIDES, which provides integrated CRDMO services for oligonucleotides, peptides, and synthetic conjugates. Both sites support the manufacturing of APIs and intermediates across a wide range of chemical modalities.

WuXi AppTec continues to invest in capacity expansion to meet growing global demand. The company’s investment in its Couvet, Switzerland, site resulted in doubling oral dose capacity over the course of 2024. Meanwhile, WuXi AppTec continued to build its U.S. (Middletown, DE) site, which is expected to commence operations by the end of 2026. In May 2024, the company announced the groundbreaking of Singapore R&D and manufacturing site; Phase I expects to commence operations in 2027.

 

About WuXi AppTec

As a global company with operations across Asia, Europe, and North America, WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable the global pharmaceutical and life sciences industry to advance discoveries and deliver groundbreaking treatments to patients. Through its unique business models, WuXi AppTec’s integrated, end-to-end services include chemistry drug CRDMO (Contract Research, Development and Manufacturing Organization), biology discovery, preclinical testing and clinical research services, helping customers improve the productivity of advancing healthcare products through cost-effective and efficient solutions. WuXi AppTec received an AA ESG rating from MSCI for the fourth consecutive year in 2024 and its open-access platform is enabling around 6,000 customers from over 30 countries to improve the health of those in need – and to realize the vision that “every drug can be made and every disease can be treated.” Please visit: http://www.wuxiapptec.com

 

]]>
WuXi AppTec’s Couvet Site Receives EcoVadis 2024 Silver Medal Rating https://sta.wuxiapptec.com/wuxi-apptecs-couvet-site-receives-ecovadis-2024-silver-medal-rating/ Mon, 18 Nov 2024 08:55:13 +0000 https://sta.wuxiapptec.com/?p=27266 WuXi AppTec’s Couvet Site Receives EcoVadis 2024 Silver Medal Rating Read More »

]]>
Couvet, Switzerland – November 14, 2024 – WuXi AppTec, a global company that provides a broad portfolio of R&D and manufacturing services to enable companies in the pharmaceutical and life science industries, is proud to announce that its facility in Couvet, Switzerland, has received a silver medal in the 2024 business sustainability ratings by EcoVadis, a leading business sustainability rating provider. This recognition highlights WuXi AppTec’s steadfast commitment to integrating Environmental, Social, and Governance (ESG) priorities into its strategy and operations.

EcoVadis provides benchmarks for rated companies in their industry to drive global supply chain sustainability and encourage industry-wide competence to achieve better global practice and continuous improvement. The ratings assess corporate performance across four core areas: Environment, Labor & Human Rights, Ethics, and Sustainable Procurement. With an impressive score, WuXi AppTec’s Couvet site ranks in the top 9% of all rated companies, showcasing its commitment to sustainable business practices.

As a state-of-the-art pharmaceutical manufacturing facility, the Couvet site plays a vital role in WuXi AppTec’s CRDMO business model by providing both clinical and commercial scale manufacturing capabilities for oral solid dosage forms. The facility was designed with industry-leading energy efficiency and environmental standards and was built to accommodate future sustainable growth.

In addition to receiving the EcoVadis silver medal, the site was also recertified for ISO 14001 & ISO 45001 accreditations to the advanced environmental, health and safety management systems that enhance its sustainability performance.

As an enabler of innovation, a trusted partner, and a contributor to the global pharmaceutical and life sciences industry, WuXi AppTec integrates ESG priorities in all aspects of its global business operations. In 2024, WuXi AppTec ranked #1 in Global Life Sciences Tools & Services Industry in S&P Global Corporate Sustainability Assessment and received an AA ESG rating from MSCI for the fourth consecutive year. The company was also named to the S&P Global Sustainability Yearbook and the FTSE4Good Index Series for the second consecutive year in both 2023 and 2024, and was recognized as an Industry and Regional “Top-Rated” company by Sustainalytics. WuXi AppTec’s outstanding ESG performance has been widely acknowledged by major global ESG rating agencies, including CDP.

Additionally, WuXi AppTec joined the United Nations Global Compact (UNGC) in 2024 in support of its ten sustainability principles, and joined the Science Based Targets initiative (SBTi) to reduce carbon emissions in 2023.

 

About WuXi AppTec

As a global company with operations across Asia, Europe, and North America, WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable the global pharmaceutical and life sciences industry to advance discoveries and deliver groundbreaking treatments to patients. Through its unique business models, WuXi AppTec’s integrated, end-to-end services include chemistry drug CRDMO (Contract Research, Development, and Manufacturing Organization), biology discovery, preclinical testing and clinical research services, advanced therapies CTDMO (Contract Testing, Development and Manufacturing Organization), helping customers improve the productivity of advancing healthcare products through cost-effective and efficient solutions. WuXi AppTec received an AA ESG rating from MSCI for the fourth consecutive year in 2024, and its open-access platform is enabling more than 6,000 customers from over 30 countries to improve the health of those in need – and to realize the vision that “every drug can be made and every disease can be treated.”

]]>
WuXi AppTec Opens New R&D Center in Changzhou, China https://sta.wuxiapptec.com/wuxi-apptec-opens-new-rd-center-in-changzhou-china/ Thu, 14 Nov 2024 03:37:06 +0000 https://sta.wuxiapptec.com/?p=27246 WuXi AppTec Opens New R&D Center in Changzhou, China Read More »

]]>
First operational building dedicated to API development for oligonucleotides, peptides, and complex synthetic conjugates.

New facility enhances the Company’s drug substance process R&D capacity to drive innovation across all synthetic modalities and meet growing global demand.

WuXi AppTec announces the recent opening of its new R&D center in Changzhou, China, significantly expanding its capabilities in developing advanced therapies covering small molecules, oligonucleotides, and peptides as well as complex synthetic conjugates. This 33-acre center of excellence offers a flexible design, strengthening the Company’s drug substance process research and development service offerings with increased capacity and accelerated timelines, while reducing costs and environmental impact.

Strategically located just 15 minutes from our existing Changzhou API manufacturing site, the new R&D Center is a critical R&D hub for both WuXi STA, the Company’s small molecule CRDMO platform, and WuXi TIDES, which delivers oligonucleotide and peptide CRDMO services. The proximity facilitates seamless collaboration between R&D and manufacturing; the Center’s state-of-the-art capabilities integrate process R&D and analytical services to support projects from preclinical through commercialization.

Designed with six R&D buildings, upon full operation, the Center will accommodate approximately 3,000+ scientists with 170+ specialized laboratories.

The first operational building, dedicated to API development for oligonucleotides, peptides, and complex synthetic conjugates, spans over 160,000 square feet. Its innovative design specifically supports development for “TIDES” Drugs with features such as specialized solvent pipelines, reclaimed process water systems, and infrared-activated fume hoods to enhance efficiency, sustainability, and safety. Currently, the first operational building houses 500 scientists. It offers a comprehensive suite of services with most advanced process and analytical technologies all designed to meet the complex demands of oligonucleotide and peptide drug development. The modular lab integrates essential workflows with latest digitalization and automation controls to achieve faster data turnaround and higher efficiency.

“This new facility reinforces our ongoing commitment to supporting customers as they advance global health,” said Dr. Minzhang Chen, Co-CEO of WuXi AppTec. “By strengthening our end-to-end CRDMO capabilities for all synthetic modalities, we further empower our partners with comprehensive solutions from discovery through commercialization, and a faster, more streamlined pathway to market. Together, we’re dedicated to accelerating more innovative therapies to patients worldwide.”

常州四期鸟瞰图 WuXi AppTec Opens New R&D Center in Changzhou, China

Rendering of the 33-Acre R&D Center Campus in Changzhou, China

]]>
WuXi AppTec Named Global CRDMO Company of the Year by Frost & Sullivan for the Eighth Consecutive Year https://sta.wuxiapptec.com/wuxi-apptec-named-global-crdmo-company-of-the-year-by-frost-sullivan-for-the-eighth-consecutive-year/ Wed, 30 Oct 2024 03:40:37 +0000 https://sta.wuxiapptec.com/?p=27437 WuXi AppTec Named Global CRDMO Company of the Year by Frost & Sullivan for the Eighth Consecutive Year Read More »

]]>
SHANGHAI, October 29, 2024 – WuXi AppTec, a global company that provides a broad portfolio of R&D and manufacturing services to enable companies in the pharmaceutical and life science industries, has been awarded the 2024 Global CRDMO Company of the Year Award by Frost & Sullivan, a growth advisory firm. This marks the eighth consecutive year that WuXi AppTec has achieved this distinction.

This recognition underscores WuXi AppTec’s enduring commitment to addressing customers’ needs with its unique contract research, development, and manufacturing organization (CRDMO) model. From discovery to commercialization, WuXi AppTec’s CRDMO model provides our customers with the highest quality standards and seamless support throughout the drug development process. Additionally, Frost & Sullivan commends the company for driving innovation, adhering to the highest quality standards, and helping customers accelerate development, improve productivity, and manage costs effectively.

“We are delighted to receive the 2024 Global CRDMO Company of the Year Award from Frost & Sullivan,” said Dr. Ge Li, Chairman and CEO of WuXi AppTec. “WuXi AppTec is committed to enhancing our unique integrated CRDMO business model to foster collaboration and drive innovation. Our customers deliver groundbreaking treatments to patients around the world, and we are honored to continue supporting these efforts with the highest quality standards and service.”

“Frost & Sullivan is impressed by WuXi AppTec’s proactive approach to addressing evolving pharma and biotech needs through its unique CRDMO business model, which enables the company to foster scientific innovation, develop distinct industry insights, and leverage opportunities in new molecules,” said Ojaswi Rana, a research analyst at Frost & Sullivan. “By continuously enhancing its capabilities and capacity, the company supports the industry and customers to bring groundbreaking therapies to patients around the world.”

Frost & Sullivan reserves this recognition for companies at the forefront of innovation and growth in their respective industries, innovating and creating new products, solutions, and services that meet ever-evolving customer needs.

 

About WuXi AppTec

As a global company with operations across Asia, Europe, and North America, WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable the global pharmaceutical and life sciences industry to advance discoveries and deliver groundbreaking treatments to patients. Through its unique business models, WuXi AppTec’s integrated, end-to-end services include chemistry drug CRDMO (Contract Research, Development, and Manufacturing Organization), biology discovery, preclinical testing and clinical research services, advanced therapies CTDMO (Contract Testing, Development and Manufacturing Organization), helping customers improve the productivity of advancing healthcare products through cost-effective and efficient solutions. WuXi AppTec received an AA ESG rating from MSCI for the fourth consecutive year in 2024, and its open-access platform is enabling more than 6,000 customers from over 30 countries to improve the health of those in need – and to realize the vision that “every drug can be made and every disease can be treated.”

]]>
New Enzyme Fermentation Plant in Changshu, China https://sta.wuxiapptec.com/new-enzyme-fermentation-plant-in-changshu-china/ Tue, 15 Oct 2024 02:45:55 +0000 https://sta.wuxiapptec.com/?p=27122 New Enzyme Fermentation Plant in Changshu, China Read More »

]]>
We’re excited to announce the latest enhancement to our Early Intermediates manufacturing facility in Changshu, China: a new enzyme fermentation plant that strengthens our biocatalysis capabilities. This expansion increases our total enzyme fermentation capacity to 22,850 L, allowing us to better meet your project’s unique needs by offering greater scalability, speed, and efficiency.

WuXi STA’s Biocatalysis Technology Platform provides comprehensive solutions, from enzyme screening, enzyme evolution and enzyme production to biocatalytic process development and production. With over 2,500 library enzymes and expertise in 25+ reaction types, we’re here to ensure your projects move forward with confidence and success. In 2023, we applied biocatalysis across 60 synthetic steps, producing over 90 metric tons of APIs and intermediates, helping our partners bring treatments to market faster and more sustainably.

]]>
WuXi AppTec Breaks Ground on New Site in Singapore to Better Support Global Customers https://sta.wuxiapptec.com/wuxi-apptec-breaks-ground-on-new-site-in-singapore-to-better-support-global-customers/ Thu, 23 May 2024 09:56:35 +0000 https://sta.wuxiapptec.com/?p=26016 WuXi AppTec Breaks Ground on New Site in Singapore to Better Support Global Customers Read More »

]]>
Photo caption (from left to right):
Ms. Cindy Koh, Executive Vice President, Singapore Economic Development Board; Dr. Minzhang Chen, Co-CEO, WuXi AppTec; Mr. Heng Swee Keat, Deputy Prime Minister; Dr. Ge Li, Chairman and CEO, WuXi AppTec; Dr. Beh Swan Gin, Permanent Secretary (Development), Ministry of Trade and Industry; Mr. Alvin Tan, Assistant Chief Executive Officer for Industry Cluster Group, JTC Corporation

SINGAPORE, May 23, 2024 – WuXi AppTec, a global company that provides a broad portfolio of R&D and manufacturing services to enable companies in the pharmaceutical and life science industries, today announced the groundbreaking of its new R&D and manufacturing site in Singapore. This milestone, following the announcement of the new site in 2022, marks another step forward in WuXi AppTec’s mission to continuously enhance its CRDMO enabling platform to better support customers worldwide in advancing healthcare treatments and innovations.

The new 50-acre Singapore site is located in the thriving Tuas Biomedical Park with the master planning and development by JTC to encompass a total of seven plants at its full capacity, providing active pharmaceutical ingredient (API) R&D and manufacturing services for small molecules, oligonucleotides, peptides, and complex synthetic conjugates. Embracing industry-leading green chemistry technology initiatives, this new site is dedicated to improving industrial practices and promoting sustainable development of the local community. As a key part of the company’s global network, the Singapore site will integrate closely with WuXi AppTec’s existing sites across Asia, Europe, and North America, offering effective CRDMO solutions for new drug R&D from discovery to commercialization with expanded flexibility and scalability.

Mr. Png Cheong Boon, Chairman of the Singapore Economic Development Board (EDB), said, “WuXi AppTec’s comprehensive CRDMO facility marks the company’s first foray into Singapore, and is a timely addition to Singapore’s thriving and growing pharmaceutical and biotechnology sector. With R&D and manufacturing activities housed under one roof, WuXi AppTec will be building a sizeable local team to drive the development of innovative therapeutics in Singapore to serve patients globally. Singapore remains committed to working with global healthcare partners to bring novel healthcare solutions to the rest of the world.”

“We are thrilled to break ground on our long-planned site in Singapore. The progress we’ve made with many of our local partners is remarkable,” said Dr. Minzhang Chen, Co-CEO of WuXi AppTec. “As we continue to enhance our capabilities and capacities to deliver high-quality solutions that meet the evolving needs of our customers, the new Singapore site will help us better serve our customers both locally and around the world.”

“At WuXi AppTec, our vision is that one day every drug can be made and every disease can be treated,” said Dr. Ge Li, Chairman and CEO of WuXi AppTec. “We are proud to work with like-minded partners in Singapore to carry out this vision for the global pharmaceutical and life sciences industry. With the enhanced capacity and capabilities we are building at this new Singapore site, we look forward to continuing to help our customers accelerate the development and commercialization of life-saving treatments and medicines for patients around the world.”

The new Singapore site is projected to start operation in 2027 and will be built in different phases. The site is expected to bring approximately 1,600 employment opportunities once fully built.

 

About WuXi AppTec

As a global company with operations across Asia, Europe, and North America, WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable the global pharmaceutical and life sciences industry to advance discoveries and deliver groundbreaking treatments to patients. Through its unique business models, WuXi AppTec’s integrated, end-to-end services include chemistry drug CRDMO (Contract Research, Development and Manufacturing Organization), biology discovery, preclinical testing and clinical research services, advanced therapies CTDMO (Contract Testing, Development and Manufacturing Organization), helping customers improve the productivity of advancing healthcare products through cost-effective and efficient solutions. WuXi AppTec received an AA ESG rating from MSCI for the third consecutive year in 2023 and its open-access platform is enabling more than 6,000 customers from over 30 countries to improve the health of those in need – and to realize the vision that “every drug can be made and every disease can be treated.”

 

Media Contact:

Davy Wu

mediainquiries@wuxiapptec.com

]]>
2024 CDMO Leadership Awards https://sta.wuxiapptec.com/2024-cdmo-leadership-awards/ Wed, 20 Mar 2024 16:51:54 +0000 https://sta.wuxiapptec.com/?p=25921 2024 CDMO Leadership Awards Read More »

]]>
Exciting moment! We’ve been honored with the 2024 CDMO Leadership Awards in all six core categories: Capabilities, Compatibility, Expertise, Quality, Reliability, and Service, again! Dr. Jinling Chen, our Senior Vice President and Head of Pharmaceutical Development and Manufacturing at STA, accepted the trophy last night at the CDMO Leadership Awards ceremony in NYC. This is the 10th time we received the CDMO Leadership Awards. We sincerely thank our global partners for their ongoing trust and confidence in our capabilities, which fuels our commitment to innovation and excellence.

]]>
New Blow-Fill-Seal Aseptic Filling Line https://sta.wuxiapptec.com/new-blow-fill-seal-aseptic-filling-line/ Tue, 30 Jan 2024 16:56:25 +0000 https://sta.wuxiapptec.com/?p=25925 New Blow-Fill-Seal Aseptic Filling Line Read More »

]]>
New Capability Spotlight: We just launched a new Blow-Fill-Seal (BFS) aseptic filling line at our drug product site in Wuxi City. Designed for eye drops and inhalants, this BFS line handles volumes ranging from 0.1 – 10 mL, fills up to 200 units per minute, and has an annual capacity of 9 million units.

To date, we have three sterile manufacturing lines, including a high potency (HP) sterile injectable line with an Occupational Exposure Limit of 10ng/m³. Our total sterile formulation capacity now stands at 33 million units annually, accommodating a wide range of dosage forms, including vials, pre-filled syringes, and cartridges.

Learn more about our parenteral platform.

]]>
New Continuous Hydrogenation Manufacturing Line https://sta.wuxiapptec.com/new-continuous-hydrogenation-manufacturing-line/ Sun, 21 Jan 2024 17:00:26 +0000 https://sta.wuxiapptec.com/?p=25928 New Continuous Hydrogenation Manufacturing Line Read More »

]]>
Site Spotlight: We’ve just added two new continuous hydrogenation lines at our Changshu site, with a throughput of 200 kg/day. Our continuous hydrogenation process supports a wide range of reactions, including nitro group reduction, debenzylation, decarbonylation, double bond reduction, and cyanide reduction, scalable from kilograms to metric tons.

Our Changshu site, specializing in producing early intermediates, is conveniently located within a 2-hour drive from our two API manufacturing sites in Changzhou and Shanghai.

]]>