Protein Impurities
Process- and Product-Related Impurities
It’s not possible to create proteins artificially. All proteins are made in biological cells which are themselves made of proteins. If you need to separate the proteins you’ve produced from the others, ask us to carry out protein purification.
We excel at detecting the residual proteins of the host cell - it’s all about sensitivity.
With other protein service providers, you’ll find that they don’t always completely remove impurities from the fermentation process, leading to low level contamination. But we have two ingredients at our fingertips that allow us to detect impurities with high sensitivity: the right mass spectrometer for the job and a dedicated bioinformatics team.
We identify and quantify all the proteins in your mixture using mass spectrometry. By carrying out a bioassay, we can also see if the impurities are influencing the efficacy. Finally, we eliminate the unwanted proteins one step at a time by focusing on the differences in their characteristics.
The process is tailored to your needs because every client’s requirements are different.
We can search for:
- Product-related impurities, which are basically types of protein modification. Examples are deamidation or oxidation. We analyze these with a combination of 2D gel electrophoresis, high performance liquid chromatography (HPLC) and peptide mapping.
- Process-related impurities, such as host cell proteins, which we can detect using ELISA, 2D gel electrophoresis, western blotting or mass spectrometry.
Characterizing protein impurities is a key requirement of ICH Q6B.
Your contact for Process- and Product-Related Impurities at Protagen AG
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Dr Katja AschermannHead of Business Development Protein Services. Phone: +49 (0) 231 9742-6300 |