Increased costs for drug development, weak product pipelines and greater competition, are forcing the pharmaceutical industry to explore the true potential of existing molecules in order to maintain or extend patent protection. The quest to stretch a molecule’s lifecycle has become at least as important as the discovery and development of new drug candidates.
At Ardena, we use our solid state research capabilities to provide new insights and techniques to assist with lifecycle management.
Our comprehensive screening programs are designed to obtain the whole range of solid forms of drug substances (polymorphs – including solvates and hydrates, salts, cocrystals and amorphous solid dispersions).
Through a sequence of experimental design, high- and medium-throughput screening and chemometric analysis, and by combining state-of-the-art analytical techniques with experimental work at different scales, the screens are designed with the highest level of experimental diversity and therefore provide the best chance of success.
Pharmaceutical Intellectual Property consulting
Intellectual Property (IP) of the relevant solid forms is vital to defend innovator patents. Our thorough screening techniques ensure identification and characterisation of the solid form landscape of a drug substance, as well as detection of potential patent infringement.
Additionally, with over a decade of experience in drafting patents of solid forms of drug substances and in collaboration with renowned patent agencies, we can assist customers in the drafting of patents and construction of claims in order to ensure protection in the most effective manner.
Counterfeit and substandard drug testing
In cases of substandard and counterfeit medicines, investigation of the solid form of the drug substance, or any of the ingredients of the formulation, is essential and may reveal differences in quality or even violation of IP.
We use our analytical equipment to characterise the solid state of the drug substance or excipients of both the genuine and suspicious products in order to pinpoint the differences.