Late Development
Accelerating products through to commercial manufacture
Speed up the journey from proof-of-concept to commercial launch
The journey from proof-of-concept to commercial launch can be complex. Speed is critical, but it shouldn’t come at the expense of product quality.
Creating patient-centric formulations and scaling up from pilot scale to commercial manufacturing, we help clients turn promising molecules into successful drug products.
Resources
Read our related case studies
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Scientific PostersAAPS 2020 Poster - Improving the Stability of a Spray-Dried Peroxide-Susceptible Drug in TabletsCompound X (Cmp-X) belongs to the class of PDE-5 inhibitors and is a BCS Class II candidate with equilibrium solubility <3 μg/mL, thus exhibiting a dissolution rate limited bioavailability. The purpose of this work is to develop an amorphous solid dispersion (ASD) by spray drying and monitor and improve the physical and chemical stability upon storage for developing a successful solid dosage formulation.
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Case StudiesDruggability TechnologiesDruggability Technologies (DRGT) is developing DRGT-46 as a novel therapy for pain. Gabor Heltovics, CEO of DRGT, explains how Quotient Sciences enabled the rapid development, clinical assessment and commercial readiness of its DRGT- 46 product using integrated services across Quotient’s network of harmonized development and manufacturing sites in the UK and US.
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Scientific PostersDevelopment of a Modified Release Tablet Containing an API Prone to Form Changes and Gelling in Aqueous MediaDevelopment of an MR formulation of Cmp-1 was planned using RapidFACT®: an integrated approach that allows formulation optimization based on human PK data with an adaptive clinical design. Selection of a discriminatory in vitro dissolution test was an important early development activity.
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Scientific PostersReal-time drug product manufacturing to enable accelerated early clinical development of spray dried dispersion based formulations - AAPS 2017This poster describes how adopting a real-time drug product manufacturing approach allowed initiation of the FIH study within 12 weeks of initiating SDD process transfer.
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