Process-Related Impurity ELISA Kits
There are a variety of process-related impurities that can persist during drug manufacturing, including growth factors from media used to culture cell lines during production of recombinant therapeutic proteins, enzymes introduced to degrade host vectors during upstream or downstream processing, or residual ligands from chromatography resins used to purify drug substances.
Cygnus Technologies offers highly sensitive and specific ELISA kits for reliable detection of several process-related impurities:
- Cell culture media components: BSA, HSA, Insulin, Bovine Transferrin, Human Transferrin
- Bioprocessing enzymes: Benzonase Nuclease® or Denarase®
- Residual ligands utilized in affinity chromatography resins (including Protein A), or for AAV viral vector purification
- Residual goat IgG and bovine IgG
