Since intensified fed-batch could rival the cell-specifc productivity of a conventional fed-batch, we developed novel hybrid strategies to either allow for acceptable seeding densities without compromising productivity, or alternatively, to push the productivity the furthest in order to reduce timelines. Both strategies improved titer by 100% in 14 days relative to the standard fed-batch process with moderate and acceptable changes in product quality attributes. Overexpressing each glycosylation gene caused little change in cell growth as indicated by the integrated viable cell density (IVCD) compared to the control culture (Fig. Yet, as intensified fed-batch may not always be possible due to limited facility operational mode, we also separately increased the q p with the addition of specifc media additives. To do so, we worked separately on the increase of the IVCD as high seeding fed-batch capacity.
cell densities in culture and elevated IVCD, is essential to isolate. One of the original protein hydrolysates used in mammalian cell culture was A. (13) dP q xdt P p ttff 0 0 Assuming that q p is constant, the equation becomes: (14) PdPqxdt P pttff 0 0 where IVCD (15) xdtttf 0 Under the constant. 4.4.2 Fed-batch cultivation revealed that clonally-derived CHO-S cell lines. The intent of this article is to focus on QbD concepts, and provide guidance and understanding on how the various components combine. While titer is influenced by the biomass (expressed as IVCD), the culture time and the cell-specifc productivity (q p), we changed independently each of these parameters to tune our process strategy towards adapted solutions to individual manufacturing needs. Protein hydrolysates enhanced both IVCD & qMab the effect on qMab being. This study describes the application of quality by design (QbD) principles to the development and implementation of a major manufacturing process improvement for a commercially distributed therapeutic protein produced in Chinese hamster ovary cell culture. from a major biopharmaceutical company, changes to IVCD and cell-specific protein.
All manufacturing approaches tend to follow the generally accepted dogma of increasing titer since it directly increases manufacturing output. Following three days of static culture on the ChemStress plate. In the field of therapeutic antibody production, diversification of fed-batch strategies is flourishing in response to the market demand.