Services in drug development

RISE offers dissolution analyses for formulations such as tablets and capsules under development or for GMP quality control of finished product. We perform method development, method validation and tech transfer of existing methods, we focus on robust arrangements adapted to the product, the dosage form and regulatory requirements.

RISE offers determination of organic solvent residues with Headspace GC in solid and liquid samples. The analysis can be performed to GMP quality level according to ICH Guidelines for drug substance and drug product, according to Ph Eur 2.4.24, or exploratory.

RISE offers determination of water content by Karl Fischer titration (KF) in solids and liquids. Analyses can be performed to GMP quality level according to Ph Eur for drug substance and drug product, or exploratory.

RISE offers analyses according to GMP or exploratory of Specific surface area using the Brunauer-Emmett-Teller (BET) method to gain information about a material's reactivity. Also measurements of Pore size and Pore size distribution. Analysis on solid samples such as powders, tablets, porous materials and catalysts.

RISE offers stability studies for quality evaluation of a product or substance during storage. Samples are held at 25°C/60%RH, 40°C/75%RH, 5°C or -18°C in validated climate cabinets/fridge-freezers with continuous monitoring, temperature and humidity log. Studies performed GMP according to ICH Guidelines on drug substance/product, or exploratory.

RISE offer an in vitro model to study pro, anti and inflammatory attributes of subtances in the signal path of NF-kB.

RISE offers an in vitro method to study the uptake of substances that are to be oraly administred.

RISE offers in vitro analysis to study interactions between the small intestine and substances or microbiota.