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The analysis of biopharmaceuticals such as recombinant proteins and peptides, and monoclonal antibodies or nucleic acid based drugs, requires a different skill set than those of small chemical entities. Many of the analytical techniques such as LS/MS/MS, and capillary electrophoresis or Real-time RT-PCR have just emerged from an R&D type setting into routine quality control operation. Nevertheless, the same demanding quality standards apply for the quality control of biological as for small molecule drugs. |
