Recent contaminations of biologics processes highlight the omnipresent threat of contamination of biological manufacturing processes. Formal assessments of raw materials and process intermediates provides assurance of freedom from extraneous agents at a level suitable for manufacture, however, the presence of viruses at low levels in raw materials and human viral vaccine intermediates provides an avenue for contamination. The quality control of viral vaccines involves developing comprehensive contamination control and risk mitigation strategies across the manufacturing process.
The extent and stage of development to perform QC testing of vaccine starting materials and intermediates are based on a microbial/viral risk assessment covering the whole manufacturing process. Both traditional and novel technologies, which are fully validated, are available. These methods are also supported by orthogonal methods of mitigating risk of contamination including testing, viral validation where appropriate, and final release testing. Selection of advanced technologies for human viral vaccines already submitted to regulatory agencies, case studies and comparative data, enabling the use of a rapid and focussed panel of assays, with exemplary timeframes for performance, will be presented.