The presence of host cell proteins (HCPs) in biologics must be strictly monitored and manufacturing processes need to be optimized to reduce impurities and their risks to a minimum. Profound sample characterization, in-depth analysis using orthogonal methods and facultative protein identification are key for successful drug manufacturing and approval by authorities such as the FDA and EMA.
For this purpose, BioGenes has specialized on the use of two-dimensional sample characterization methods with state-of-the-art equipment and highly qualified staff. Complementing these HCP analytics services with orthogonal mass spectrometry, we can provide reliable HCP surveillance strategies.
2D Electrophoresis (lysine-dependent fluorescent minimal labeling, fluorescent total protein staining, Coomassie or silver staining)
2D Western Blot for determination of HCP coverage (fluorescence based)
2D Difference Gel Electrophoresis (2D-DIGE) for comparative analysis of spot patterns
Immunoaffinity Chromatography (IAC) with 2D DIGE as orthogonal method for HCP coverage determination
Mass Spectrometry for protein identification and HCP reagent characterization
If you would like to learn more about how HCP Analytics supports your Host Cell protein monitoring during DSP processing in various stages of drug development, please have a look at our webinar (see below).