Biopharmaceutical products must be free of host cell proteins (HCPs) for approval by authorities such as the FDA and EMA. Thus a profound sample characterization, in-depth analysis using orthogonal methods and facultative protein identification is key for successful drug manufacturing.
For this purpose, BioGenes has specialized on the use of two-dimensional sample characterization methods with state-of-the-art equipment and a highly qualified staff.
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
If you would like to learn more about how 2D Analytics supports your HCP monitoring during DSP processing in various stages of drug development, please have a look at our webinar (see below).