As an integrated services provider, 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 built to meet USP 795, 797, and 800 compounding standards. The compounding pharmacy is part of our contract research organization (CRO) facility in Miami, FL where we conduct Phase I trials with healthy volunteers.
In 2020, an upgrade was done to help our customers accelerate to first-in-human (FIH) testing and seamlessly supply drug products for downstream proof-of-concept (POC) patient trials. The laboratory space was expanded to support our new pharmacy 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. Additionally, clean rooms in the facility 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.
Within the pharmacy and clinic, 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.
Flexible compounding and GMP manufacturing delivers significant benefits when transitioning from FIH to POC
By simplifying the supply chain with a single development partner and integrated project team, we are able to help customers through their stages of development, to:
- Quickly start a first-in-human (FIH) trial with healthy volunteers, using a fit-for-purpose pharmacy preparation
- Develop a solid oral drug product (such as a tablet) for patient trials within the same program
- Seamlessly start proof of concept (POC) patient trials with immediate clinical trial material supply
In this approach, a more cost-effective dosage form, such as PIC or PIB, can be used to start the FIH trial. This also has the benefit of improving timelines to the clinic, while still providing maximum dose flexibility to achieve Phase I objectives of obtaining PK and safety data.
Later, emerging clinical data can be used to evaluate formulation technologies, such as solubility enhancement, within the FIH study to select a drug product to move forward with. 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. Finally, once the optimal formulation and formulation technology is selected, the new solid oral dosage form can be manufactured, ready for packaging and shipment for patient trials.
Learn more about our pharmacy compounding capabilities, or contact us to get started talking about your next program.