| Qualitative analysis of biosimilars | |
|---|---|
| Laboratory | D15 |
| Equipment | 400, 600, 800 MHz Bruker NMR spectrometers |
| Filed | Chemical analysis |
| Platform | NMR |
| Technics | Qualitative analysis of biosimilars |
| Contact | Janez Plavec janez.plavec(at)ki.si +386 1 4760 353 |
| Description | Biosimilars and biological products are drugs made from living organisms through highly complex manufacturing processes and must be handled and administered under carefully monitored conditions. A biosimilar is exactly what its name implies — it is a biologic that is “similar” to another biologically made drug substance (known as a reference product) which is already licensed by the U.S. Food and Drug Administration (FDA). With the use of NMR we were pioneers to develop methods that selectively saturate excipients signals enabling us to perform analysis on final products. |
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