Pharmaceutical outsourcing specialist Quay Pharma is strengthening its range of pre-clinical services with the establishment of a partnership with XenoGesis, the UK’s largest independent laboratory-based CRO, which specialises in pre-clinical DMPK, quantitative bioanalysis, in vitro pharmacology and expert interpretation.
The partnership will help to accelerate the drug development process for both companies’ clients, with Quay able to optimise dosing formulations ahead of efficacy, pharmacokinetic and toxicological pre-clinical studies, while XenoGesis can ensure a molecule’s DMPK profile is suitable to underpin not only pre-clinical studies but also for moving into first in human (FIH) studies.
Quay is recognised as one of the world’s leading CDMOs, offering a complete service through all stages of drug development and clinical supply as well as pre-qualification batches to support Marketing Authorisation applications and initial manufacture of commercial product.
The Quay and XenoGesis partnership will comprise an initial pre-formulation DMPK health check by XenoGesis to determine the suitability of the API for formulation. Quay will then provide a range of formulations for evaluation. Any data gap filling DMPK studies that may be required can be undertaken in parallel with Quay’s pre-clinical formulation optimisation to progress development as quickly as possible.
Dr Rachel Hemsley, Global Head of Business Development at XenoGesis said: “We have a strong synergy with the team at Quay. Their expertise in oral dosage form design and semi solids formulation and development, especially for drugs that exhibit poor solubility and bioavailability, is of particular importance. In the pre-clinical space, Quay can assess solubility and short-term stability using minimal API, utilising a rapid turnaround and cost-effective screening platform to select solvents and excipients that are tailored to the characteristics of each individual API.”
This ability to optimise formulation at an early stage means that bioavailability profiles can be improved, and the exposure levels achieved during toxicology studies enhanced. These data also allow for a seamless progression into clinical formulation development.
“We are delighted to be working with XenoGesis,” commented Dr Audrey Vardy, Quay’s Head of Business Development – Pre-clinical. “Our complementary skills and expertise will give new projects the best chance of success, identifying appropriate formulation solutions and progressing molecules quickly and cost-effectively towards clinical evaluation.”