XenoGesis has partnered with pharmaceutical outsourcing specialist Quay Pharma to strengthen its preclinical services, specifically in the area of formulation.
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 preclinical studies, while XenoGesis can ensure a molecule’s DMPK profile is suitable to underpin not only preclinical 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 products.
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 preclinical formulation optimisation to progress development as quickly as possible.
Dr Rachel Hemsley, Global Head of Business Development at XenoGesis said, “XenoGesis works with clients to develop basic formulations in-house. Through our trusted CDMO partner network, we are also able to offer state-of-the-art dosage technology and formulation.
“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 preclinical 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 – Preclinical. “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.”
XenoGesis works with a number of trusted and carefully selected partners and consultants to provide a range of formulations and evaluation. To find out more about formulation services from XenoGesis and our network of CDMO partners, click here.