As an industry, we need to do far more to implement technologies and work with FDA, not only to keep them informed, but to make sure they are aware of industry trends and newer technologies. Remember that CBER and
CDER have their own labs, and in many cases, they will want to bring in the technologies you want to use and see how they work in their own experiments…
Tag: <span>process monitoring</span>
Viable cell density (VCD), the quantitative assessment of living cells, is commonly determined by laborious and inaccurate off-line cell counting methods. Single-function in situ probes have been developed using various technologies including optical density, radio frequency and dielectric permittivity. Optical density measurements predict total biomass but are sensitive to cell debris accumulation and inherent media turbidity. Near-infrared (NIR) has the advantage of being able to measure many key analytes in the cell culture simultaneously. NIR has been used to acquire real-time measurements of glucose, glutamine, glutamate, and media nutrients such as amino acids and metabolites (e.g., lactate and ammonia). NIR probes can be sterilized in place, and real-time measurements can be acquired throughout the mammalian cell culture processes…