Seamlessly Transition from Pharmacy Compounding to GMP Drug Product
Quotient provides integrated solutions to help clients achieve their proof-of-concept milestone quickly, saving them precious development time and money. Begin your First-in-Human (FIH) Phase I testing with a fit-for-phase, simple pharmacy preparation, and then seamlessly transition to a scalable, solid oral GMP drug product for Phase II trials, without missing a beat.
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 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.
Benefits of Using an Integrated Pharmacy-Manufacturing Approach
- Quickly & cost-effectively start clinical testing with a fit-for-phase pharmacy preparation
- Manage CMC investment in dosage form development appropriately as a molecule progresses and key elements are de-risked
- Select an appropriate dosage form for the FIH trial which provides maximum dose flexibility to achieve Phase I objectives
- Evaluate different formulation options and select a lead system to move forward
- Develop and bridge to a solid oral drug product for patient trials within the same program of work
- Seamlessly start Phase II trials on-time with immediate supply of clinical trial material
- Minimize the number of vendors and simplify the supply chain
- Manage quantities of API and drug product costs
Quotient’s State-of-the-Art Compounding Pharmacy
Located at our clinical pharmacology site in Miami, FL, our compounding pharmacy has been purposely built to support rapid and cost-effective dose preparations including oral solutions, suspensions, drug or powder in capsule or bottle, and sterile preparations for parenteral delivery for both active pharmaceutical ingredient (API) and GMP intermediates. 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.
Supported Dosage Forms:
- Powder-in-Capsule
- Liquid-in-Capsule
- Over-Encapsulation
- Solutions
- Suspensions
- Parenteral (IV, IM, SC)
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.
Leverage A Partner Who Can Seamlessly Take You from Pharmacy Prep through to Commercial