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

Tags: Drug Substance Formulation Development Drug Product

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

Tags: Drug Product

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

Tags: Drug Product

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

Tags: Formulation Development Drug Product

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

Tags: Drug Product

Analytical & Microbiological Support to Clinical Research Unit

Challenge: Development and validation of analytical and microbiological methods for Intravenous (IV) products manufactured extemporaneously (EP) at Clinical Research Unit. Testing

Tags: Drug Product