Quotient Sciences’ focus is on delivering the most appropriate formulations to expedite your clinical program, through dosing within our own Phase I clinical facilities or at an external site. We work with you to support rapid progression to your first-in-human evaluation where required, ensuring that your ultimate drug product presentation goals can be seamlessly transitioned following confirmation of molecule safety and tolerability. Our formulators’ experience is built on years of work integrating formulation development and clinical evaluation. As a result, our development is based on an understanding of the intended indication including drug products designed for chronic dosing or for pediatric populations.
Our breadth of formulations developed for first-in-human studies includes:
- APIs in a bottle or capsule
- Solubility-enhanced dosage forms
First-in-Human to Proof-of-Concept
Our Translational Pharmaceutics approach enables First-in-Human studies by re-engineering the transition of your drug molecule into clinical development and shortening the timeline to Proof-of-Concept.
Development and optimization of MR formulations in the absence of predictive laboratory or preclinical models
The integration of formulation design space, real-time GMP manufacturing, and an iterative sequential pharmacokinetic (PK) study in healthy volunteers was successfully applied to develop an HPMC matrix tablet that achieved the desired PK characteristics for SLx-2101.The key formulation variables influencing performance were the range of dose and release rate, hence a two-dimensional (2D) design space was mapped by manufacturing and characterizing four “regulatory batches” bracketing the corners of the compositional ranges.
Integrated Early-Stage Drug Development and Manufacturing: Accelerating Molecules to Proof-of-Concept
This webinar highlights how by breaking down the barriers between traditional outsourcing channels and workflows, drug development activities and key functional groups including formulation development, manufacturing and clinical research can be much more closely integrated to accelerate early-stage drug development, reduce overall expenditure and shorten time to proof of concept.
Global Formulation Development and Manufacturing Capabilities
We provide full service support for small molecule non-sterile programs, from dosage formulation development through to GMP clinical trial manufacturing and commercial drug product supply.