Case Study - Integrated CMC to IND in 10 Months

Biotech and pharma innovators are facing considerable challenges to find CDMO partners with capacity and capability to quickly develop and deliver high-quality CTM with flexible options+

The journey for new therapies is long; wondering if a proven therapy will be produced and distributed efficiently to reach the intended markets as soon as possible should not be another burden

WuXi will use its new modality platform to provide an end-to-end solution for oligonucleotide peptide

WuXi STA's IND Enabling Preformulation Package (IEPP) is an integrated developability assessment service for new chemical entities (NCEs) to efficiently identify challenges and solutions earlier for higher success rates and lower overall costs. This video explains the package and process.

The purchase of BMS's Couvet, Switzerland facility adds commercial-scale production capacity for capsule and tablet dosage forms

F2CS - fast to clinical supply service package delivers reliable clinical trial materials (CTM) fast with flexible options custom developed by highly experienced integrated teams equipped with advanced technologies, working in parallel to save time.

WuXi STA has been deeply involved in the CDMO industry for more than ten years. In the year of 2020 alone, WuXi STA served more than 470 customers worldwide, supporting 13 NDA approvals globally including 5 from US FDA, 4 from EU EMA, 2 from China NMPA and 2 from Japan PMDA.  Dr. Minzhang Chen, CEO of WuXi STA, commented: “Thanks to our partners for their recognition of WuXi STA, and we will continue to leverage our end-to-end CMC platform, along with the global standard quality systems to empower more partners to accelerate their pathway to market for the benefit of global patients.”

WuXi STA's pre-formulation package IEPP (IND Enabling Pre-formulation Package) helps you select the best drug candidates at late discovery phase and develop the most suitable formulation for phase I in 8-12 weeks, 

STA Pharmaceutical, a WuXi AppTec company (WuXi STA), a leading contract development and manufacturing organization (CDMO) announces that three of its sites in China have successfully passed pre-approval inspections (PAI) by the China National Medical Products Administration (NMPA) concurrently for an innovative drug from its partner. 

The achievement validates the company's CMC capabilities and quality

STA Pharmaceutical Co., Ltd., (WuXi STA) – a subsidiary of WuXi AppTec – today announced the opening of its large-scale oligonucleotide oligonucleotide active pharmaceutical ingredient (API) manufacturing facility in Changzhou, China. This significant milestone marks WuXi STA's establishment of a comprehensive one-stop platform to support the process R&D and manufacture of oligonucleotide APIs from preclinical to commercial. It enables customers around.

Bristol Myers Squibb (NYSE: BMY) and WuXi STA – a subsidiary of WuXi AppTec – today announced that WuXi STA has agreed to purchase Bristol Myers Squibb’s manufacturing facility in Couvet, Switzerland. The Couvet site will be the first facility in Europe for WuXi STA, a leading Contract Development and Manufacturing Organization. The acquisition will enhance WuXi STA’s existing capabilities while growing capacity to support its partners’ life-saving work.

The acquisition will expand the CDMO's capabilities and capacity to serve European markets

The Wuxi companies will provide process development, scale-up, and GMP to advance Antengene's ADC program to clinical stage