If HPLC is the gold standard what are the advantages of the Cedex?

Answer

For some of the relevant analytes in bioprocess control (Eg: IgG or amino acids), HPLC enables a very accurate analysis, but requires:

· Highly trained and experienced operators

· Suitable standard materials from another source

· A specialized lab environment (HPLC is not executed at-line near the bioreactors)

· Manual sample preparation (filtration, protein precipitation, etc), which takes time and can be error-prone

· Delayed time to result (up to several days!) due to the need to send samples to a separate analytics lab

The Cedex Bio and Bio HT analyzers provide results of high accuracy, comparable to the more laborious “gold standard” methods like HPLC with added advantages including:

· Availability in the direct environment of the bioreactors

· Providing results within minutes

· Don’t need any sample preparation, cell culture samples can be placed directly on the analyzer

· Can be operated by any lab technician, after a short training of the basic functions

· Offer a comprehensive and expandable test menu, and all required materials are provided by Roche