presented by Natalie Perraudeau, Team Leader Biotherapeutical Analytics, on the occasion of the 22nd International Conference and Exhibition on Pharmaceutical Formulations, July 04-06, 2019 Valencia, Spain (Publications)
The integrity of an API is essential for its required efficacy and safety. This integrity depends on the stability, secondary and tertiary structure, aggregation behavior and concentration of the developed molecule, factors which are highly influenced by the formulation of the API. We address such critical quality attributes by applying state of the art analysis techniques:
During formulation studies orthogonal methods are used: To address aspects of higher order structure we apply orthogonal methods like FT-IR analysis in aqueous solution, CD analysis and fluorescence scan. Stability is elucidated by DSC equipped with autosampler, enabling high throughput screening. To assess aggregation behavior, we use highly sensitive DLS and AUC methods as well as SEC-methods equipped with MALLS detection and AF4-MALLS providing a broad range of orthogonal methods for detailed characterization. To precisely determine concentration, we offer AAA or HPLC and photometric techniques. As an expert in all these methods PPS is constantly extending its method portfolio and expertise to steadily improve our support in the formulation field for our sponsors.
The poster presentation will illustrate the broad portfolio of methods available at PPS for formulation studies. If you are searching a partner in this field, please contact us. We are delighted to find the right answers to your questions in biopharmaceutical formulation analysis.