Integrating Pharmacy Compounding & GMP Manufacturing
Accelerating your molecule from first in human (FIH) to proof of concept (POC)
Quotient Sciences provides integrated pharmacy compounding, formulation, Good Manufacturing Practice (GMP) manufacturing, and clinical testing solutions to help clients achieve their POC milestones quickly, shortening development time while reducing costs. Begin your FIH Phase I testing with a simple, fit-for-purpose pharmacy preparation and then seamlessly scale up your solid oral GMP drug product for Phase II trials, all within one organization.
Quotient Sciences’ 3-step approach
1. Quickly start your FIH trial with a fit-for-purpose pharmacy preparation
o Use a cost-effective dosage form for the FIH trial that 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 chemistry, manufacturing, and controls (CMC) investment or active pharmaceutical ingredient (API) consumption at this early stage of development. Dose preparations can be made in real time, which 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 FIH protocol design.
The longer-term goal, however, is to advance the molecule into Phase II patient trials. At Quotient Sciences, 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 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 Sciences’ biopharmaceutics and formulation development expertise. Working across the entire development spectrum, from pre-clinical to commercial supply, Quotient Sciences’ 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.
Benefits of using an integrated pharmacy-manufacturing approach
- Quickly and 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 that 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 Sciences’ state-of-the-art compounding pharmacy
Located at our clinical pharmacology facility in Miami, Florida, our 2,500 ft2 compounding pharmacy has been 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 API and GMP intermediates. Built with the necessary International Organization for Standardization (ISO) 5 and 7 standards in place, our pharmacy meets United States Pharmacopeia (USP) 795, 797, and 800 compounding requirements to ensure both operator and patient safety for high-potency and high-risk molecules up to Performance-Based Level of Exposure Classification (PBLEC) 5. Our pharmacy is fully integrated with Quotient Sciences' pharmaceutical development and GMP manufacturing facilities located in the US and UK.
Dosage forms we support
- Powder-in-capsule
- Liquid-in-capsule
- Over-encapsulation
- Tablets*
- Solutions
- Suspensions
- Parenteral (intravenous [IV], intramuscular [IM], subcutaneous [SC])
*prepared in Quotient Sciences’ manufacturing facilities to GMP standards
And since Quotient Sciences is a full-service drug development, manufacturing, and clinical testing organization, we can seamlessly transition you from a simple FIH pharmacy preparation to a scalable dosage form for POC patient trials and beyond.
Get started today.
Quotient Sciences can help you rapidly go from FIH testing to POC trials. Contact us today to discuss your project.
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Info SheetIntegrated Pharmacy Compounding and GMP Manufacturing Fact SheetQuotient Sciences provides integrated pharmacy compounding, formulation, GMP manufacturing and clinical testing solutions to help clients achieve their proof-of-concept (POC) milestone quickly, saving them precious development time and money. Begin your First-in-Human (FIH) Phase I testing with a fit-for-purpose, simple pharmacy preparation, and then seamlessly transition to a scalable, solid oral GMP drug product for Phase II trials, all within one organization.
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