Disulfide bond reduction occurred now and then during a recombinant
protein manufacturing. Their reduction often led in the loss of batches.
Various prevention measures were developed. Their implementation in a
manufacturing inevitably increases its operation complexity and even
might impact its product qualities and process performances. It is
highly desirable to apply a reduction measure only if necessary and to
apply no strong measure if a moderate one works. The reduction
occurrence is determined both by the reduction sensitivity of a
recombinant molecule and by the reduction power of harvested cell
culture fluids. The reduction power of harvested cell culture fluids
varies largely and depends on cells, lysis level, growth stage, and
culture conditions. The method of the quantitative risk assessment of
disulfide bond reduction was reported here. The quantitative assessment
is realized by comparing the reduction sensitivity of a recombinant
molecule with the reduction power of its harvested cell culture fluid.
Quantitative Risk assessment of product disulfide bond reduction in a recombinant protein manufacturing