The contract development and manufacturing organisation (CDMO) launched its Quick-to-Clinic service at a facility in Whitby, Ontario in 2008 , providing pharma companies with a rapid-response means of making solid dosage forms for early phase clinical trial.
Patheon has since expanded the service in order to offer it from sites in Cincinnati, Ohio, Milton Park, UK, and Tilburg, the Netherlands, and last week announced a further update which the firm says accelerates the production of Phase I material across six dosage forms.
“In the previous Quick to Clinic we marketed a four month timeline which has been reduced to 12 weeks,” a spokesman from the CDMO told Outsourcing-Pharma.com.
“All pharma and biotech companies recognise the need to accelerate drug development, either to progress to next milestone/clinical phase or indeed to kill the compound altogether,” he continued, adding all firms - whether emerging or large pharma - are looking to make drug development more efficient and improve their return on investment.
“Availability of cGMP API is typically on the critical path so anything that can be done in getting drug product to First in Humans more quickly is always of interest to the industry.”
The 12 week timeline focuses on BCS Class I molecules – drugs with high permeability and high solubility - in 6 of available dosage forms, with softgels the latest addition to API in Capsule, Blend in Capsule, API in bottle, Blend in bottle, and Oral Liquid. “Each project will be evaluated and custom programme developed as needed to fit the project goals and the molecules characteristics,” we were told.
Patheon merged with the pharmaceutical product segment of Royal DSM to form DPx Holdings earlier this year, though we were told this updated service was not related to the $2.65bn (€1.9bn) deal .