Cell culture media related impurities
Upstream: from essential additive to possible contaminant
Whereas some reagents or compounds are essential for optimal performance in bioreactors, they may pose a risk in the finalized dosage form. Validated quantitative methods of detection are as important as means of removal to ensure delivery of constantly formulated substance, product, or cellular therapeutic.
In order to supply manufacturers with a cost effective set of tools to address regulatory requirements, we can build on generic methods where available, or flexibly adept customer methods into fully qualified or ICH compliant validated assays. It is of importance to consider that it must always be proven that a certain method delivers validated results in the context of the matrix it is sampled from. Our trained staff can pave the way into smooth routine testing.
- Growth factors
- Media components
- Surfactants & Antifoams
- HPLC/UPLC with a variety of detectors (UV, ELSD, Fluorescence)
- Mass spectrometry
- (Capillary) electrophoresis
Contact us to discuss your needs.