Bio Process >> Residuals Testing and Process related impurities >> Downstream derived impurities

Downstream derived impurities

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Buffer remaints, enzymes, separation media; what is removed and what stays in?

Transformation of reactor harvest to drug product is a windy road, in which many compounds are brought into contact with the partially processed API. Validated quantitative methods of detection are as important as means of removal for delivery of constantly formulated substance, product, or cellular therapeutic.

In order to supply manufacturers with a cost effective set of tools to address regulatory issues, we can build on generic methods where available, or flexibly adept customer methods into fully qualified or ICH compliant validated assays. It is of importance to consider that it must always be proven that a certain method delivers validated results in the context of the matrix it is sampled from. Our trained staff can pave the way into smooth routine testing.

Residuals

  • Buffers
  • Enzymes
  • Surfactants & Antifoams
  • Process-Enhancing and Purification Agents
  • Solvents
  • Metals

Techniques

  • HPLC/UPLC with a variety of detectors (UV, ELSD, Fluorescence)
  • Mass spectrometry
  • NMR
  • (Capillary) electrophoresis

Contact us to discuss your needs.