Nottingham, UK – Molecular Profiles Ltd., a subsidiary of Columbia Laboratories, Inc., (Nasdaq: CBRX) is set to unveil the ROADMAP to Clinical Trials platform at the annual CPhI/ICSE Worldwide event in Paris and at AAPS 2014, which aims to support companies with the rapid development of both standard and complex drug products.
The new enabling technologies screening platform, which incorporates the company’s existing formulation and analytical development modules, streamlines the development of effective and bioavailable drug products.
Supported by a dedicated in-house technical group that specialises in complex research science, enabling technologies rapid screen brings together several advanced processing capabilities including hot melt extrusion (HME), nano milling, SEDDS/SMEDDS and spray drying, which allows Molecular Profiles to investigate, evaluate and recommend a development pathway to clients that is the best option based on science.
Claire Madden-Smith, commercial director at Molecular Profiles, explains: “There are critical decisions that clients can now make at an early stage in the drug development process, which can have major, longer term consequences for their compounds.
So the idea behind our ROADMAP to Clinical Trials platform is to provide a robust streamlined pathway to clinic. Even for challenging product development we have introduced a screening process, which can provide strong scientific evidence based on in-vitro and in-vivo data to help progress to formulation optimisation in less than eight weeks.
“Ultimately, it’s about rapidly assisting clients to choose a development pathway that will be the most time, cost and volume efficient route for their valuable product,” added Claire.
Over the last two decades, Molecular Profiles has built a strong reputation in advanced characterisation, IP consultancy and sophisticated analytical services. Differing from many larger CROs, the company provides firms with outsourced research and development activities that enable pharmaceutical companies to accelerate formulation development and clinical trial timelines.
The announcement comes after the UK-based pharmaceutical development and manufacturing services provider made a major investment into additional equipment, as part of a wider project focusing on enabling technologies earlier this year, that facilitate processing of difficult-to-progress molecules.
As part of the creation of its enabling technologies package, Molecular Profiles recently announced a collaboration with fellow Nottingham-based company XenoGesis that adds additional expertise in preclinical drug metabolism and pharmacokinetics (DMPK) to its enabling technologies platform.
The strategic alliance will 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, which have solubility issues during formulation development.
Dovetailing its development capabilities, Molecular Profiles manufactures a range of finished dosage forms for clinical trials spanning solids, liquids, semi-solids and inhaled products, including potent compounds and controlled drugs, from its MHRA-licensed facility.