Biopharmaceutical inspections and analysis in a laboratory
Your needs: to analyze your biological substances in accordance with relevant standards
The biopharmaceutical industry covers the preparatory phase of biological products such as serums or vaccines. They study the galenic from of medications (pills, injectables, sachets…) looking into the way they are absorbed into the body and how they are metabolized.
Medications and other biological products are subject to numerous regulations imposed by health authorities to ensure that these products are efficient, of high quality and do not pose a risk to the health of the consumer. Cooperation with a laboratory makes it possible to ensure that your biopharmaceutical products comply with everchanging standards.
Our solution: to provide you with our expertise and to analyze your biological products in accordance with standards
Biological products are made up, for the most part, of large and complex molecules or mixtures of molecules. FILAB’s expertise will help you better understand the composition of your products by using cutting-edge analytical techniques.
We support the pharmaceutical and biopharmaceutical industries by providing various analytical services:
- Chemical composition analysis of biological products using GC-MS, HPLC, ICP or IC
- Development, validation and transfer of analytical methods in accordance with the ICO Q2 guideline on biopharmaceutical products
- E&L testing
- Accelerated aging tests and analysis of degradation products
- Detection of elemental impurities in pharmaceutical products in accordance with the ICH Q3D guideline
- Powder analysis: PSD, specific surface area, morphology…
