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Fast market-entry: “We shortened the purification process with at least 1 year”

Detailed host cell protein overview enables targeted elimination of impurities

This client worked on the purification process of an E. coli expressed protein. When discovering too high level of Host Cell Proteins (HCPs), they did not know how to optimize the process.

With the Alphalyse SWATH LC-MS-based HCP analysis they got a list of specific HCPs along with amount and physiochemical properties of each individual HCP. This enabled them to pinpoint the problem with HCPs and to intelligently optimize the purification process within a week.

The client is a clinical-stage biotech company with European headquarters and offices in USA. They develop next generation biopharmaceuticals in the form of antibody mimetics.

The Alphalyse HCP analysis by SWATH LC-MS was performed on several process samples. The analysis quantified the total HCP amount (ng HCP/mg drug substance), as well as measured the amount of each HCP in every sample. The results included physio-chemical parameters such as molecular weight, pI and amino acid sequence. In addition, they received the database names and accession numbers of all the identified E. coli proteins.

This detailed HCP outline of the entire purification process allowed the client to actively modify the process steps. Consequently, they were able to remove all HCPs to a level below acceptance criteria and skip tiresome purification matrices.


Clinical-stage biotech company_logo
"Previously, we spent tremendous time and money on HCP purification processes, because we had no idea which clearance methods would be most efficient. With Alphalyse results, we intelligently removed the HCPs and have shortened the processes with at least one year compared to previous projects."

Clinical-stage biotech company- Senior Manager, Process Development

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