Analytical Development

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The Analytical Research and Development team plays a key role in the process of developing a new medicine, analysing and characterising prototypes to assess their quality, stability and performance. Using a wide range of analytical techniques, the team gathers essential information to identify the strengths and weaknesses of each formulation, guiding decision-making around the selection of the most promising candidates.

These activities cover both protein-based medicines and topical and transdermal products, to which specific analytical approaches are applied.

For protein-based medicines, the team uses established techniques such as high-performance liquid chromatography (HPLC) and gas chromatography (GC) to determine the content of active ingredient and impurities. When these methods are combined with mass spectrometry, the result is in-depth structural characterisation of the proteins, providing essential information used to assess their identity, integrity and quality. The analysis procedures carried out also include the dissolution test, used to study the behaviour of oral pharmaceutical forms and verify the performance of tablets in terms of the release of the active ingredient.

For topical and transdermal products, the focus instead is on the formulation’s ability to release the active ingredient and promote its absorption through the skin. The permeation test is used for this purpose, to assess penetration of the active ingredient through the skin barrier. An automated system is used to measure the release of the active ingredient from topical pharmaceutical forms – such as medicated plasters – in order to obtain essential data used to optimise their efficacy and performance.

Find out about the other stages in the product development process: