Establishment of the bioassay laboratory
Monoclonal antibodies (mABs) are used in the diagnosis and therapy of a wide variety of diseases. In the area of new drug approvals, mABs represent an important group, so that the need for analytical investigations of mABs will increase in the future. For this purpose, the bioassay laboratory was established at InphA in 2020 to be able to determine the potency of mABs.
The TNF-alpha neutralisation assay is established, which is based on a cell-based determination of the inhibitory effect of the monoclonal antibody on the biological activity of TNF-alpha. The TNF-alpha neutralisation assay can be used to determine the biological activity of monoclonal antibodies such as certolizumab, adalimumab, infliximab or golimumab.
Identity and purity testing by
- Peptide mapping
- Size exclusion chromatography (HPSEC)
- Ion exchange chromatography (IEX-HPLC)
- Capillary electrophoresis (CE/DAD)
- Gel electrophoresis (SDS-PAGE)
- isoelectric focusing (IEF)
- Reversed phase HPLC