Design space for biotech products

The concept of "design space" requires that a biotechproduct Is designedsothat It Willmeet its desiredclinicalperformance,and the process Is designed to consistenlly deliver a product that meets the quality attributes necessary for this clinical performance.The primarybenefit 0f an approved design space is regulatory flexibility,most notobly the patential to make process improvements within the -design space without regulatory oversight. To achieve the required level 0f process knowledge, however,processcharacterizationwill need to be extensive and encompass a wide range of pracess parameters.