Quotient Sciences, a global pharmaceutical development, clinical and commercial manufacturing organization, announced today the completion of a $1 million dollar pharmacy and laboratory expansion at their Miami, FL clinical pharmacology facility. The expanded pharmacy capabilities offer customers a quick and cost-effective way to start clinical testing, without the need for extensive CMC investment or API consumption at this early stage of development. Dose preparations can be made in “real-time” enabling clients to make seamless adjustments to the dose or formulation and respond to changes in the first-in-human (FIH) protocol design.
The pharmacy’s compounding capabilities are differentiated in the marketplace as they are uniquely integrated with Quotient’s broader formulation development and GMP clinical trial manufacturing capabilities at sites in the US and UK. This combined offering helps clients efficiently bridge from a fit-for-purpose Phase I formulation to a patient-friendly GMP drug product for subsequent Proof-of-Concept (POC) trials. All of this can delive r an accelerated timeline without the need for the customer to have to work with multiple vendors.
“Quotient is focused on providing our clients with solutions to get new medicines to patients faster.” said Mark Egerton, CEO Quotient Sciences. “When starting clinical development, our customers have a choice between pharmacy preparations or GMP drug product manufacturing. At Quotient, all options and program configurations are available for our clients, to help them reach their development milestones in the timeliest and most cost-effective way.”
The new state-of-the-art pharmacy was built with ISO class 5 & 7 standards in place, and follows USP 795, 797 and 800 compounding guidelines in order to support both sterile and non-sterile drug programs. The facility is equipped with the necessary handling capabilities for highly-potent and high-risk molecules, supporting a variety of oral and parenteral dosage forms. The pharmacy is located within Quotient’s clinical pharmacology facility, which features 144 clinical beds for performing first-in-human and other Phase I healthy volunteer trials.
For those with challenging molecules, clients can also leverage Quotient’s biopharmaceutics and formulation development expertise including a full range of solubility enhancement technologies including lipidic systems, micronization, spray drying and hot melt extrusion, to produce solubilized intermediates and final dosage forms.
This article was written by Medilink EM Patron, Quotient Sciences.
