Formulation Development
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Formulation Development, Early Phase
Our oral solid formulation development teams, comprised of more than 1,000 scientists, have rich experience in pushing your candidates from preclinical studies to pivotal clinical, process optimization via DoE, process validation, and NDA registration, until commercialization.
We have tackled challenges ranging from solubility issues and excipient incompatibility to vehicle stability and controlled release, etc. And we successfully enabled 7 drug product approvals for the global market.
We established a comprehensive technology platform that covers a wide range of oral dosage forms, utilizing cutting-edge enabling technologies, including spray dried dispersion, hot melt exclusion, nano-suspension and lipid formulation. And high potency oral drug is also supported.
Speed
- 1-6 weeks for formulation development
- 4-6 weeks from GMP API received to phase I CTM released (F2CS)
- 6 months from technology transfer to release of PPQ completed (F4CL)
Experience
- 1,000+ preclinical-phase 3 molecules supported
- 48 PPQs completed, 8 commercial projects
- 2,400+ batches manufactured (2023)
Fast to Clinical Supply (F2CS) Service Package
F2CS, the abbreviation of “Fast to Clinical Supply”, features a drug product service package with delivery timeline as short as 4-6 weeks from the point of API receipt to clinical trial materials (CTM) arrival at the clinic. F2CS delivers CTM reliably and fast with flexible options provided by highly experienced and integrated teams equipped with state-of-the-art facilities and cutting-edge technologies. F2CS is your reliable partner to formulate and manufacture your therapy to meet the IND filing requirements for phase I studies, accelerating your programs along with our clinical packaging and distribution services.
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Formulation Development, Late Phase
Our dedicated late phase teams have rich experience in pushing your candidates from early stage to pivotal clinical, process optimization via DoE, process validation, and NDA registration, until commercialization.
We have supported validation of 20+ NCEs since 2019 with 100% PPQ success, and have successfully enabled 7 drug product approvals for the global market. Our GMP facilities in Shanghai, Wuxi city, China and Couvet, Switzerland have been inspected by the US FDA, EMA, China NMPA, Japan PMDA, SwissMedic and many other regulatory agencies, equipped with advanced commercial equipment for spray dried dispersion, hot melt extrusion, dry/wet/fluid bed granulation, continuous manufacturing, high potency drug product and many more.
Speed
- Technology transfer to release of PPQ completed in 6 months (F4CL)
Experience
- 500+ molecules in Phase II and beyond (2022)
- 2,800+ clinical and commercial batches manufactured (2022)
- 8 commercial projects
Fast for Commercial Launch (F4CL) Service Package
When your CMC projects approach to the final step of commercialization – NDA submission, you need to consider how to ensure your drugs successfully reach your intended markets. Our dedicated drug product service package – Fast for Commercial Launch (F4CL), can support your commercial launch in global markets in parallel with speed, reliability, and quality.
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Related Resources
Spray Dried Dispersion from Preclinical to Commercial
