Document removal of process-related residual proteins in all purification steps

Question:   My company develops and produces a biologic. Recently, regulatory authorities asked us to document how efficiently downstream purification reduces the...

Sep 25. 2019 | Ejvind Mørtz |
elisa-coverage

Can I use commercial HCP ELISA kits for my clinical trial application?

Question: My company uses a commercial HCP ELISA kit for host cell protein analysis of clinical phase 1 material. We hear...

Jul 10. 2019 | Ejvind Mørtz |

Host Cell Protein monitoring & control in process development

Mass spectrometry based Host Cell Protein identification and quantification   The Mass Spec Host Cell Protein (HCP) assay is applied for monitoring...

Oct 2. 2009 | Ejvind Mørtz |
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