Quotient Sciences completes integration of drug substance into Translational Pharmaceutics platform

Quotient Sciences has integrated drug substance into its Translational Pharmaceutics platform. The newly integrated service unites drug substance, drug product and clinical testing activities all within a unified organisation and under a single project manager, the company notified via a statement.

The full integration of drug substance R&D and manufacturing follows a year after the company’s acquisition of its Alnwick, the UK site, and provides a more streamlined approach from candidate selection through to commercialisation. Quotient Sciences Translational Pharmaceutics approach – combining manufacturing and clinical dosing at a single organisation – enables innovators to adjust formulations and dosing in real-time, the statement added.

“Our Translational Pharmaceutics platform is now in its 15th year and has accelerated development timelines for more than 500 drug programmes. We remain the only outsourcing partner able to offer innovators the ability to manufacture, release and dose under one organisation. This approach is proven to shave 12-months of timelines and, by adding drug substance synthesis, the timeline from candidate selection to the clinic can be further accelerated by two-to-four months,” said Mark Egerton, CEO, Quotient Sciences, in the statement.

The statement further said that Translational Pharmaceutics was developed in consultation with the MHRA and FDA and employs a rapid “make-test” cycle, where drug products are manufactured, released and dosed in a clinical study in days rather than months. This means biotechs and pharma companies can fast-track molecules from First in Human (FIH) through Proof of Concept (POC).