07 29 21 -- FDA s New Guidance On CMC Changes To An Approved Application pharmaceuticalonline.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from pharmaceuticalonline.com Daily Mail and Mail on Sunday newspapers.
Monitoring O2 and CO2 Using Benchtop Bioreactors
Thought LeadersDr. Patrick Floris Characterisation and Comparability LabNIBRT
In this interview, Dr Patrick Floris talks to AZoM about experiments in cell culture and the role of off-gas analysis in his research which he performed as part of the collaboration between Thermo Fisher and the Characterization and Comparability Lab at NIBRT
Can You Give an Overview of Your Research Experiments in Cell Culture, in Particular the Experiments Featured in Your Published Material?
The publication of interest discussed typical mammalian cell culture processes using a CHO-K1 host.
Our goal was to use these processes as a template to evaluate the integration of multiple PATs and relatively new technologies, such as the magnetic sector MS from Thermo Fisher, to do online process and product characterization within the same platform.
Real-time Characterization Of Mammalian Cell Culture Bioprocesses By Magnetic Sector MS
By Patrick Floris, a Noemí Dorival-García, Graham Lewis, Graham Josland, Daniel Merrimanb and Jonathan Bones
The complexity of mammalian cell culture processes for biopharmaceutical manufacturing has resulted in the rapid development of Process Analytical Technology (PAT) tools aimed at improving batch-to-batch reproducibility through the implementation of real-time process monitoring techniques. In particular, on-line platforms can provide rapid access to key performance indicators (KPIs) and critical process parameters (CPPs) which can assist the operator s decision-making process and facilitate the timely implementation of required corrective actions.
In this paper mammalian cell culture processes were characterized upon the analysis of the exhaust-gas composition achieved through the on-line integration of a magnetic sector MS analyser with benchtop bioreactors. The non-invasive configura