Modern drug manufacturing of biologics and biosimilars require modern, quick, and approved solutions for in-process control and QC release. Check out Roche CustomBiotech's offerings for this field of application.
Fermentation In-Process Control
Processes for producing therapeutic proteins have to be checked at regular intervals and can last for several days or even weeks. At least once per day, substrates such as glucose, glutamine, or glutamate, and also the formed metabolic products such as lactate and ammonium, are determined. The Cedex Bio and Cedex Bio HT Analyzers offer outstanding performance for this application. In addition, the parameter (LDH) serves as indicator for cell death.
Find out how the Cedex Analyzer portfolio supports your fermentation process
Mycoplasma testing at various stages in the production process is a regulatory requirement for certain drugs, biologics, and medical devices. Time-consuming culture-based methods can be replaced by the MycoTOOL Test after thorough validation. Release testing with the MycoTOOL test is approved by the EMA (European Medicines Agency), the FDA and several other authorities for release testing.
The removal of host cell impurities is a critical step in the production of biopharmaceutical products. The Roche Residual DNA CHO Kit and the Residual DNA E. coli Kit, based on proven realtime qPCR technology, make testing of residual DNA fast and reliable.