Molecular Profiles, a contract development and manufacturing organization (CDMO) subsidiary of Columbia Laboratories, and CRO XenoGesis are collaborating to support pharmaceutical and biotech drug developers during the preclinical and formulation development stage. Molecular Profiles' pharmaceutical development services will be supported by XenoGesis' experience in preclinical drug metabolism and pharmacokinetics (DMPK) to give clients a smarter route into formulation development and a better understanding of a compound's bioavailability.
The alliance will allow the Nottingham, U.K.-based companies to help drug developers in the initial design and selection of compounds for key DMPK and ADME (absorption, distribution, metabolism and elimination) studies, as well as supporting lead candidates that have solubility issues during formulation development.
Frank Condella, president and CEO of Columbia Laboratories, said, "We have complementary service offerings, which allow us to apply a science-driven, collective approach to overcome the complexities of challenging molecules. It also adds a vital PK service to our enabling technologies package.”
XenoGesis was founded by its managing director, Richard Weaver, Ph.D., after a 15-year career at AstraZeneca. The company specializes in studying research compounds from a chemical and biological perspective to inform clients on how they will behave in the body.
Weaver said, "Combining our skills in DMPK with the chemical knowledge at Molecular Profiles will provide a solid platform to support clients. We will be able to give them a better understanding of their compounds during preclinical work, which in turn will reduce cost and provide a quicker route to market."
Molecular Profiles specializes in advanced characterization, pharmaceutical product development, clinical trials manufacturing and analytical support. The company recently created a new enabling technologies team and invested in GMP hot melt extrusion (HME) technology at its clinical manufacturing facility to further enhance its expertise in the processing of difficult-to-progress molecules.
Alongside its development capabilities, its MHRA-licensed site enables the company to manufacture a range of dosage forms for clinical trials spanning solids, liquids, semi-solids and inhaled products, including potent compounds and controlled drugs.