Initially the draft PAT guidance document originally issued by the FDA’s CDER office was only applicable for well defined small molecule drugs. Within 5 years this perspective evolved to include biological products such as monoclonal antibodies. This resulted in the A-mAb case study report last year in which a mock application of a fully PAT/QbD compliant process for the production of a monoclonal antibody was described. The findings and implications of this report reach further to even less defined products such as vaccines. Vaccines are perhaps the most heterogeneous group of pharmaceutical products, including well defined polysaccharides but also whole inactivated bacterial cells. This means that an off-the-shelf PAT solution for vaccines is impossible. However, basic principles and tools such as acquiring a sufficient level of process understanding or applying DoE to explore the process design space are generic for any (bio)pharmaceutical manufacturing process. In this presentation the general approach as followed in the A-Mab case study and its implication for PAT/QbD application on vaccines will be discussed.

Adoption of the Q10 model for a pharmaceutical quality system should facilitate innovation, continual improvement and strengthen the link between pharmaceutical development and manufacturing activities. Industry surveys indicate a potentially $20-$30 billion more in profit gain, when applying QbD initiatives. Significant reduction of Cost of Goods Sold (COGS) and capital expense, increased technical development productivity are key factors to drive the costs down and increase continuous process knowledge to significantly decrease cost of non-compliance. This presentation will highlight how integrated informatics tools are enablers to create start-to-finish knowledge management repository to support successful QbD adoption across all levels of the organization from senior management, through scientists and engineers responsible for products in development and manufacturing, processes, equipment and facilities.