The First Bone-Seeding Treatment for Osteoporotic Hips to Minimize the Fracture Risk

Purpose and goal:

The STRONG HIPS biomaterial platform is developed to strengthen osteoporotic bone locally. The chemical characterization of the product HA2, had to be performed for the biological safety evaluation according to the ISO-10993 series. Adjustments of available protocols and validations of the analytical methods were needed due to the complex nature of the HA2.

Methods for the confirmation of component composition, detection of potential leachables and impurities and investigations of nanoparticles were part of the analytical aspects targeted. Expected results and effects:

The methods for the quantification of the three main components were successfully developed and two of them are now fully validated. The quantification of the ancillary drug was just as challenging as expected and several methods were tested with non-conclusive results.

One of the components, added in nanoparticle form, was further investigated by TEM. The size and the organisation of the particles were studied.

The potential leachables and impurities were investigated using standardised methods allowing risk assessment to be performed. Approach and implementation:

A series of different products were prepared to aid the development and validation for each analytical method for the quantification of components. One of the potential impurities were specifically targeted in developing a limit test.

The potential leachables were identified using an extraction of the container in both water and IPA and consecutive analyses by ICP/MS, GC/MS and LC/MS.

The potential impurities were analysed by selective monitoring by the identified risk compounds using different analytical techniques.