WuXi STA

Our bioavailability toolbox offers a customizable solution to your drug delivery challenges. 

- Spray-Dried Dispersion (SDD)
- Hot Melt Extrusion (HME)
- Nano-suspensions & Lipid Nanoparticles 
- Softgel & Liquid Filled Capsules
- Injectable Formulations\

WuXi TIDES's Peptide platform includes a complete offering of services to bring your protein therapeutic to market faster while supporting a wide variety of conjugates including PPMO, Peptide-Antibody, Peptide-Linkers.

Services include but are not limited to: - Comprehensive Discovery Service...

WuXi TIDES has a robust and integrated Oligo API Platform, offering R&D and manufacturing services from preclinical to commercial scale and operating out of our US FDA inspected facility based in Changzhou, China. We support the development and manufacture of a variety of oligonucleotide modalities inc...

Our Jinshan and Changzhou sites are equipped with multiple R&D labs as well as a dedicated cGMP HP Kilo lab and plant for producing and manufacturing highly potent APIs (HPAPI's), antibody drug conjugates (ADC's), payloads, and payload-linkers. We currently offer drug product manufacturing at STA’...

Our comprehensive suite of analytical services help to supplement the development and manufacture of your product, ensuring high quality and consistency throughout the process.

Services include: 
- Analytical method development and validation  
- API and drug product release tes...

Our drug product pre-formulation and formulation development services can also includes in vivo PK studies, conducted with multiple animal species and a rapid turnaround time. This additional service further extends our full suite offering to our clients while eliminating the need for additional vendor sou...

WuXi STA offers a wide range of tailored  services and solutions for clients developing injectable formulations. Form types include solution, emulsion, sterile powder (lyophilized) and liposome. Our offering includes formulation development, performance analysis and characterization testing, and fill/...

WuXi STA's dedicated Global Regulatory Affairs CMC teams offers comprehensive CMC documentation support for IND, CTA, MAA, and NDA applications in western countries and China. Our highly experienced team works with your NCE programs to prepare Module 2 and Module 3 of your regulatory dossier through foreca...

At WuXi STA, we understand the need for flexibility at the early stages of clinical testing and how aspects such as effective dose, stability and compliance requirements can change your needs abruptly. Our packaging team will work with you to collect the relevant data and test various packaging options as ...

WuXI STA's comprehensive drug product development platform for oral dosage forms offers our clients a complete line of solutions from pre-formulation development through to final product manufacture at commercial scale. Our capabilities include; 

• Solid oral tablet/capsule (including liquid...

WuXi STA's Clinical Supply Services provide you with full life cycle management from global comparator sourcing, labelling and packaging, storage and distribution, as well as return and destruction. Our industry-leading CMC project management is carried out in an integrated “teamwork” mode, which ensures a...

Your innovative therapy is ready to reach a key milestone with the IND date quickly approaching. You need a reliable partner to formulate and manufacture your therapy to meet the IND filing requirements and the dose needs for phase I studies fast.

Every innovation is unique so your partner needs...

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

A Case Study of WuXi Speed and Service for a client. The project, which encompassed an integrated CMC approach to bring a molecule to IND phase was completed in 10 months

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'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,