LC-MS HCP assay validation and GMP release testing for complex samples

May 2023, by Thomas Kofoed

Analytics for advanced therapies

𝗗𝗼 𝘆𝗼𝘂 𝗵𝗮𝘃𝗲 𝗽𝗿𝗼𝗯𝗹𝗲𝗺𝘀 𝗱𝗲𝘃𝗲𝗹𝗼𝗽𝗶𝗻𝗴 𝗮 𝗽𝗿𝗼𝗰𝗲𝘀𝘀-𝘀𝗽𝗲𝗰𝗶𝗳𝗶𝗰 𝗘𝗟𝗜𝗦𝗔?

The complexity of some products, like advanced therapies and proteins expressed in E. coli inclusion bodies, makes it impossible to produce suitable antigens for raising ELISA antibodies.

Instead, you can utilize mass spectrometry (MS)-based protein analysis – now available under GMP conditions and as a release assay for phase 3 and commercial production. Get access to a method with several advantages:

✅ High coverage and sensitivity
✅ Suitable for Sf9, A549, HEK, E. coli, and Vero cell lines, e.g.
✅ Can demonstrate comparability between batches
✅ Costs a fraction of the development of a process-specific ELISA
✅ Customizable for your process – initial (non-GMP) data available in weeks
✅ Available for validation and release test under GMP conditions

Watch to learn how you can benefit from using MS data to characterize HCPs.

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