1. Quickly start your FIH trial with a fit-for-purpose pharmacy preparation
o Use a cost-effective dosage form for the FIH trial which provides maximum dose flexibility to achieve Phase I objectives
2. Bridge formulations within the same FIH protocol
o Evaluate formulation technologies and dosage forms in order to select a patient-ready formulation to move forward with
3. Seamlessly supply product to start POC patient trials
o Have immediate clinical trial material supply ready for packaging and shipment
Pharmacy compounding offers a simple and streamlined pathway to start FIH 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” and gives our clients the flexibility to make quick and informed changes to the dose or formulation based on human data in order to respond to changes in the first-in-human (FIH) protocol design.
The longer-term goal however is to advance the molecule into Phase II patient trials. At Quotient, our compounding pharmacy, GMP manufacturing and clinical pharmacology services are fully integrated and led by industry leading project managers, helping clients to successfully bridge to a patient-friendly GMP drug product for their Proof-of-Concept (POC) trials. All of this can be achieved in a compressed timeline and without the need for multiple vendors.
For those with challenging molecules, clients can leverage Quotient’s biopharmaceutics and formulation development expertise. Working across the entire development spectrum from preclinical to commercial supply, Quotient’s GMP manufacturing capabilities include immediate and modified release capsules and tablets, and 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.
Located at our clinical pharmacology site in Miami, FL, our compounding pharmacy has been purposefully built to support rapid and cost-effective dose preparations including oral solutions, suspensions, drug or powder in capsule and sterile preparations for parenteral delivery for both active pharmaceutical ingredient (API) and GMP intermediate. Built with the necessary ISO 5 & 7 standards in place, our pharmacy follows the USP 795, 797 and 800 compounding guidelines to ensure both operator and patient safety and has handling capabilities for highly-potent & high-risk molecules up to PBLEC 5.
*prepared in Quotient’s manufacturing facilities to GMP
And since Quotient is a full-service drug development, manufacturing, and clinical testing organization, we can seamlessly transition you from a simple First-In-Human (FIH) pharmacy preparation to a scalable dosage form for Proof-of-Concept (POC) patient trials and beyond.