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Formulation Development , Miami , Pharmacy Compounding , Clinical Pharmacology

The benefits of an integrated compounding & GMP manufacturing strategy

Integrated Pharmacy Compounding at Quotient Sciences

Quotient Sciences focuses on supporting our customers with the ability to move quickly and cost-effectively from candidate selection to commercial launch. 

Our compounding pharmacy in Miami, FL was upgraded in 2020 to help our customers accelerate to first-in-human (FIH) testing and seamlessly supply drug products for downstream proof-of-concept (POC) patient trials.

Our compounding pharmacy in Miami, FL was built to meet USP 795, 797, and 800 compounding standards. We can handle a variety of dosage forms including active pharmaceutical ingredients (APIs) or processed intermediates in oral solutions, suspensions, powder-in-capsule (PIC) or powder-in-bottle (PIB), and sterile preparations for parenteral delivery. Our clean rooms are built to ISO Class 7 air quality standards with ISO Class 5 Primary Engineering Controls (PEC) which include laminar airflow workbenches (LAFWs) and biological safety cabinets (BSCs), allowing us to handle potent APIs. 

The laboratory space was expanded in order to support our new pharmacy offering and provide efficient processing of higher volumes of biological samples. It incorporates refrigerated centrifugation capability and storage at -20, -40, and -80C, and biological safety cabinets for microbiological work, allowing us to perform complex sample processing. 

Our integration of flexible compounding and GMP manufacturing within the FIH-to-POC program delivers major benefits. By simplifying the supply chain with a single development partner and integrated project team, we are able to help customers:

  • Quickly start an FIH trial with a fit-for-purpose pharmacy preparation: Use a cost-effective dosage form (PIC, PIB, Solution, Suspension) for the FIH trial which provides maximum dose flexibility to achieve Phase I objectives of obtaining PK and safety data
  • Develop a solid oral drug product (tablet) for patient trials within the same program: emerging clinical data can be used to evaluate formulation technologies (ie. Solubility Enhancement) within the FIH study to select a drug product to move forward with
  • Seamlessly start POC patient trials with immediate clinical trial material supply: the new solid oral dosage form can be manufactured, ready for packaging and shipment

The ability to manufacture and dose multiple formulation types in real-time, coupled with the ability to use smaller batch sizes and abbreviated data packages, ensures CMC time and cost investments can be carefully managed. For molecules that have solubility and bioavailability challenges, we help clients select the right formulation technology for their poorly soluble molecules. We apply a data-driven process based on the physicochemical and biopharmaceutic properties of the API with a full range of solubility enhancement technologies including lipidic systems, micronization, spray drying, and hot melt extrusion.

For more information about our compounding capabilities, click here or contact us.