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The Benefits of an Integrated Compounding & GMP Manufacturing Strategy

  • Antonio Regueira, Nutan Gangrade
  • June 24, 2020

Quotient focuses on supporting our customers with the ability to move quickly and cost-effectively all the way from candidate selection to commercial launch.  This latest pharmacy upgrade with our integrated development and GMP manufacturing capabilities will help our customers to accelerate first-in-human (FIH) testing and then seamlessly supply drug product for downstream proof-of-concept (POC) patient trials.

What does Quotient Sciences new state-of-art pharmacy offer?

Our new compounding pharmacy was built to the highest of standards, meeting 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) that include laminar airflow workbenches (LAFWs) and biological safety cabinets (BSCs), allowing us to handle potent APIs. 

The laboratory space has also been expanded in order to support our new pharmacy offering. The expansion provides efficient processing of higher volumes of biological samples and incorporates refrigerated centrifugation capability and storage at -20, -40 and -80C. The laboratory is also equipped with biological safety cabinets for microbiological work, allowing us to perform complex sample processing. 

How does the pharmacy fit in with Quotient’s broader service offerings?  

Quotient is the only global, full-service drug development partner that provides pharmacy compounding, formulation development, GMP manufacturing and clinical testing all under one organization. By simplifying the supply chain with a single development partner and integrated project team, we are able to accelerate early development in three key steps:

Step 1. Quickly start the 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

Step 2. Develop a solid oral drug product (tablet) for patient trials within the same program

- Use the emerging clinical data to evaluate formulation technologies (ie. Solubility Enhancement) within the FIH study to select a drug product to move forward with

Step 3. Seamlessly start POC patient trials with immediate clinical trial material supply

- Manufacture the new solid oral dosage form, ready for packaging and shipment

If a compound has challenging properties, what options exist?

The majority of NCEs entering development have sub-optimal solubility presenting challenges to development teams as they try to control CMC investments whilst shortening their development time to reach POC. For molecules that have solubility and bioavailability challenges, clients can leverage our biopharmaceutics and formulation development expertise.  Each drug candidate is unique and at Quotient, 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, we help clients select the right formulation technology for their poorly-soluble molecules.

How does this integration of services help?

Our integration of flexible compounding and GMP manufacturing within the FIH-to-POC program delivers major benefits to customers. The ability to manufacture and dose multiple formulations types “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. Drug development programs using this integrated approach have been shown to get our clients to proof-of-concept up to 15 months faster than traditional multi-vendor development models.

For more information about Quotient’s new compounding capabilities visit: https://www.quotientsciences.com/services/clinical-pharmacology/Integrating-Pharmacy-Compounding/

 

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