IP support
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Comprehensive screening

Increased costs for drug development, weak product pipelines and, particularly, increased 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. Lifecycle management is a strategic exercise for the pharmaceutical industry for which solid state research provides new insights and techniques.

Crystallics' 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.

IP consulting

Innovative pharmaceutical companies identify and patent new chemical entities. At the same time, generic drug manufacturers are constantly challenging the positions of innovator patents. Intellectual Property (IP) of the relevant solid forms is vital to defend innovator patents.
Crystallics’ thorough screening and advanced characterization techniques ensure identification and characterization 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, Crystallics 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

A counterfeit medicine is a product which is deliberately and fraudulently mislabeled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient (inadequate quantities of) active ingredient(s) or with fake packaging.

Substandard medicines are genuine medicines produced by legitimate manufacturers that do not meet the quality specifications that the producer says they meet. This may not be an intention to cheat, but may be due to problems with the manufacturing process. They arise mostly due to the application of poor manufacturing practices by the producer or when a good quality medicine is stored and distributed under improper conditions leading to deterioration of the quality of the product.

In both of the aforementioned cases, 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 intellectual property.

Crystallics utilizes its analytical equipment to characterize the solid state of the drug substance or excipients of both the genuine and suspicious products in order to pinpoint the differences.