Ark Biosciences taps WuXI STA for CMC development

By Maggie Lynch contact

- Last updated on GMT

(Image: Getty/otawa)
(Image: Getty/otawa)

Related tags: CMC, RSV, Wuxi apptec, WuXi STA, marketing authorization

WuXi AppTec subsidiary, STA Pharmaceutical partners with Ark Biosciences for CMC development of RSV therapy.

Ark Biosciences will use China’s Marketing Authorization Holder (MAH) system to accelerate its drug development.

Through the partnership with WuXi STA, Ark Biosciences will be able to optimize manufacturing processes, reduce commercial production costs, mitigate business risk, and improve operational efficiency.

The contract development and manufacturing organization (CDMO), WuXi STA, will provide its integrated process R&D manufacturing solution for the chemistry, manufacturing and controls (CMC) development for Ark’s drug candidate and current pipeline.

Ark Bioscience has a pipeline of active discovery programs and in-licensed drug assets for clinical development, including its drug candidate, Ziresovir (AK0529), an F-protein inhibitor for the treatment of respiratory syncytial virus (RSV). The therapy has completed three Phase I clinical trials and is currently in a global phase II clinical trial.

WuXi STA has been in collaboration with companies to enable domestic innovative drug development.

Related news

Related products

show more

Manufacturing Cyto and Non-Cyto Drugs in One Facility

Manufacturing Cyto and Non-Cyto Drugs in One Facility

Baxter BioPharma Solutions | 05-Nov-2018 | Technical / White Paper

Recent market reports suggest increasing product niches, which may lead to decreasing numbers of units per product, making dedicated facilities less practical....

Baxter’s Oncology Contract Manufacturing

Baxter’s Oncology Contract Manufacturing

Baxter BioPharma Solutions | 29-Aug-2018 | Product Brochure

Baxter BioPharma Solutions’ FOYA award-winning facility in Halle/Westfalen, Germany, offers state-of-the-art parenteral cGMP manufacturing at one location,...

Discover Fermion’s new API unit 4 in Hanko

Discover Fermion’s new API unit 4 in Hanko

Recorded the 04-Sep-2018 | Webinar

Join this webinar to learn more about Fermion’s new manufacturing unit 4 at the Hanko site. This webinar will provide virtual tour to our new state of...

Related suppliers

Follow us

Featured Events

View more

Products

View more

Webinars