Fast to Clinical Supply
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F2CS - Fast to Clinical Supply
Drug Product Service Package Designed to Deliver CTM for Phase I Clinical Trial Fast
Your innovative therapy is ready to reach a key milestone – the IND submission. When the date quickly approaches, you need a reliable partner to formulate and manufacture your therapy to meet the filing requirements and the dosage needs for phase I studies fast.
Every innovation is unique, and so your partner needs to offer the right mix of formulation and dosage form options and rapidly use data-driven models to determine the best option – not a one-size-fits-all mindset.
WuXi STA’s F2CS package applies our capability, expertise, and advanced technologies to deliver your clinical trial material fast. F2CS is our promise of formulation development and CTM supply both within 8 weeks.
Why have confidence in the F2CS promise?
WuXi STA teams are highly experienced with 1,500+ scientists, supporting 3,000+ preclinical-phase II molecules in 2023 across a wide variety of molecules in different dosage forms. Our integrated teams develop appropriate formulations utilizing a variety of dosage forms including a complete bioavailability enhancement toolbox for fast delivery of CTM with the best chance of success.
Fast – Our integrated drug substance, drug product, analytical, and CMC writing teams work in parallel to save time and complete your project fast. Our large team and facility capacity are able to accommodate unexpected changes fast to ensure on time and on budget delivery.
Flexible – Our facilities and teams are equipped and experienced with a wide variety of dosage forms and processing tools. They have access to the most advanced bioavailability enhancing technologies enabling the selection and design of a dosage form that best achieves optimal exposure.
Integrated – Drug product and analytical teams are located at the sites within 2 hour drive from drug substance teams, making collaboration, problem-solving, scheduling, and material transfer fast and simple.
Bioavailability Enhancement Technologies
- Spray Dried Dispersion
- Hot Melt Extrusion
- Nano Suspension
- Lipid Formulation
Flexible Formulation & Process Options
- API in bottle or capsule
- Powder in capsule
- Tablets
- Lipid Formulation
- Roller Compaction
- Direct Compression
- Wet Granulation
Integrated CMC Services
- API Process R&D and Manufacture
- Analytical Development & Validation
- Stability Testing
- Packaging and Labeling
- CMC Writing
- Proven Quality and EHS System
Fast to Clinical Supply
