Solvias AG services

Long-term stability studies according to ICH guidelines. On-going and follow-up stability studies. Comparability studies. Stress tests, forced degradation. Photostability testing according to ICH guidelines. In-use tests, freeze-thaw cycles. Excipient/API compatibility. Interaction studies with primary packaging. Stability protocols, reports and interim reports. Stability indicated method development. Identification of unknown/new impurities.

We understand that early assessment of a protein biopharmaceutical’s stability can be invaluable, even during pre-development. For drug substances and drug products all stability aspects can be monitored including long term and accelerated stability studies, in use studies, short term temperature excursion studies, and forced degradation studies according to ICH guidelines Q5C and Q1B.

We provide rapid and comprehensive support for your early-phase drug development process, enabling you to establish `critical mass` – in terms of personnel and know-how – in the chemical and analytical development of complex small-molecule drugs.

The analytical aspects of pharmaceutical development are demanding, as in contrast to pure drug substances, matrix effects need to be taken into account. As one of the most skilled and experienced companies in the field of pharmaceutical development analytics, we can meet your challenges!

The majority of drugs are administered as solids. This means that apart from the molecular structure of the active ingredient, solid-state properties significantly influence the performance of the final product. New substances with pharmaceutical activity are often weak acids or bases or may have unsuitable solid-state properties. In such cases, it may be preferable to develop the drug as a salt or co-crystal form.