Enhancement of field stability and utility of future biologicals through prior accelerated degradation testing

Abstract

The scepticism about the future utility of newer biologicals towards reducing disease morbidity or mortality at the public health or application level can be regarded as appropriate. The financial or research inputs into producing anti-idiotypic, subunit, cloned or genetically engineered products may not be transcribed to the field level due to political or economic impediments and the putative breakdown of any specific activity at the application level, as with the conventional immunobiologicals, may also negate the utility of the newer products. Such an eventuality should be overcome by planning, during the pre-licensure phase, appropriate accelerated degradation tests on newer biologicals.