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Strategies for Accelerating the Development of Modified Release Oral Forms

Integrating Pharmacy Compounding and GMP Manufacturing

Accelerate through First-in-Human Testing and Seamlessly Supply Drug Product into Patient Trials

Start FIH with Fit-for-Purpose & Continue to POC with a Patient-Ready Product

Quotient 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.  

Quotient’s 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 which 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 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 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 & 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 facility in Miami, FL, our 2,500ft2 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 active pharmaceutical ingredient (API) and GMP intermediates. Built with the necessary ISO 5 & 7 standards in place, our pharmacy meets USP 795, 797 and 800 compounding requirements to ensure both operator and patient safety for highly-potent & high-risk molecules up to PBLEC 5. Our pharmacy is fully integrated with Quotient’s pharmaceutical development and GMP manufacturing facilities located in the US and UK.

Supported Dosage Forms:

  • Powder-in-Capsule
  • Liquid-in-Capsule
  • Over-Encapsulation
  • Tablets*
  • Solutions
  • Suspensions
  • Parenteral (IV, IM, SQ)

*prepared in Quotient’s manufacturing facilities to GMP

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 Rapidly Take You Into FIH Testing, and Seamlessly On Towards POC Trials:  The Pharmacy Compounding to GMP Manufacturing Transition.

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Quotient Sciences Miami Clinical Pharmacology Facility

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