QbD (Quality by Design) is the recent systematic, scientific, risk-based, holistic, proactive approach & regulatory requirement for designing and developing the product and the manufacturing process to achieve the predefined product quality objectives and to reduce rejection or reprocessing of the batch, with increased cost and regulatory burden.
New Castle Disease is one of the most common causing factors which can affect the high demand of the poultry eggs and meats. Although vaccines are commercially available to have protection against the New Castle Disease infection in poultry, there is need for the sero monitoring and quick detection of the developed antibody in the poultry.
QbD concept is to be adopted for the development and manufacturing of the New Castle Disease (NDV) antibody detection test kit to have the detection kit with identified and required target profile. The results of the adaptation is to be evaluated on the products manufactured after the QbD concept is built into process of development and manufacturing of the NDV antibody detection.