Drug Product Case Studies
API Manufacture, Formulation Development, Capsule Product Manufacture Case Study
Challenge: Accelerate first-in-human and Phase II trials for an oral dosage form intended for treatment of CNS disorders. A fully integrated approach was required, to incl
Accelerated Development to Clinical Studies Rapid Manufacture - Precision Filling Case Study
Challenge: To rapidly manufacture a GMP-compliant API-in-capsule product for use in Phase I and Phase II clinical trials. The product was being investigated for trea
Intravenous Formulation Phase 1 Study Challenge Case Study
Challenge: To develop stable sterile formulations of a drug substance for intravenous administration in phase I clinical trials. The drug substance, intended for the
Chromatographic Development & Application Case Study
Challenge: Development of a modern, single, chromatographic procedure for a marketed tablet product that would allow the resolution and quantification of four active species and e
Accelerated Manufacturing Case Study
Challenge: A strategy of rapid clinical progression – dose determination to manufacture and to patient administration within 4 days, necessitating a timeline of dose determinati
