SHANGHAI—The end of July saw STA Pharmaceutical Co. Ltd. (STA)—a WuXi AppTec group company offering an open-access capability and technology platform for small-molecule pharmaceutical development and manufacturing—announce that it has merged with WuXi AppTec’s Pharmaceutical Development Services (PDS) division.
The PDS division offers preformulation and formulation development, as well as clinical trial material (CTM) manufacturing, packaging and labeling of oral solid-dosage forms including tablets, capsules, sachets and oral solutions/suspensions. PDS also established various enabling technology platforms for low-soluble drugs including spray-dried dispersion, hot-melt extrusion, micro- or nano-suspension and liquid-filled hard gelatin capsules. Two commercial-scale drug product manufacturing facilities currently under construction are expected to become operational later this year and early next year, respectively.
STA Pharmaceutical, after this merger, will provide fully integrated small-molecule active pharmaceutical ingredient (API) and drug product solutions to global clients, resulting in a what the company calls a “seamless chemistry, manufacturing and control working process.” The merger reportedly will enable STA to advance new chemical entities from preclinical stage to New Drug Application and to market faster and more efficiently for pharma and biotech customers.
According to WuXi, “This development enhanced STA’s end-to-end capabilities as a full-service contract development and manufacturing organization (CDMO), and it anticipates rapid growth in clinical trial supply, especially amongst early-stage targets, where there are practical benefits in working with one CDMO.”
“STA has been growing rapidly over the last few years. It was a natural progression for the company to add drug product to our API platform in which we are globally renowned,” said Dr. Minzhang Chen, CEO of STA Pharmaceutical.
“The merging of the PDS division into STA is an important step for WuXi,” added Dr. Ge Li, chairman and CEO of WuXi AppTec. “Providing API and drug product services under one STA entity further strengthens WuXi’s comprehensive CDMO offering. Ultimately, our platforms advance vital new medicines through the development cycle faster, allowing our global partners to discover and develop better medicines for patients.”
In other recent STA news from a bit earlier in July, the company had announced it signed a supply agreement with the oncology-focused biopharmaceutical company TESARO Inc. for certain starting and intermediate materials for Zejula (niraparib).
Under the five-year agreement, STA will supply certain starting and intermediate materials for the recently launched drug, an orally active PARP inhibitor for the treatment of ovarian cancer.
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