A powerful PAT tool
Quality by Design (QbD), promoted by reglementary agencies, requires to define a design space where production parameters could vary without product quality degradation during the development of bioprocesses. This is achieved through increased process understanding with robust measurements of Critical Process Parameters (CPP) and Critical Quality Attributes (CQA). QbD implementation in biopharmaceutical manufacturing is complex and requires specific and adapted Process Analytical Technology (PAT) tools. Raman spectroscopy technology is a non-destructive, swift and robust method to simultaneously measure multiple analytes. This is why Raman Spectroscopy has become a preferred PAT solution in the development and manufacturing of biopharmaceutical products to simultaneously monitor in-line and in real-time multiple CPPs and CQAs with a single probe.
In production, Raman spectropscopy can offer a robust mean of automation to provide a process under control.
Widely used in USP, Raman enables to monitor in-line and in real-time many parameters such as cell density (total and viable cell densities), glucose, ammonium, lactate, glutamic acid and protein titer. All parameters are simultaneously monitored with a single probe inside the bioreactor. Raman also enables contamination early detection.
During mAb manufacturing process, Raman enables to monitor in-line and in real-time antibody concentration, aggregation and glycosylation.
For vaccine manufacturing, Raman enables to monitor in-line and in real-time viral particle concentration and virus inactivation without any sampling.
Raman PAT tools can be easily used with single-use technologies. A sterile connector, such as Kleenpak™, enables to safely connect 
