Dosage: Multidose vs unit dose, preservative for multi-dose.
Container Type: Viral, syringe, nasal presentation.
Fill Volume: Overage, headspace considerations.
Fill Speed: Based upon vaccine attributes (viscosity, thermal stability, liquid consistency).
Existing Equipment Capability: Hold-up volume, capacity, change parts availability.
Final Product Form: Is the final form a liquid or powder requiring reconstitution with diluent?
In addition to clinical trials and test results that require FDA approval for efficacy of the vaccine, these tactical considerations must be addressed to bring the vaccine to market.
This paper is a comparative analysis between the application of the FDA Process Validation Guidance (2011) to new products and legacy products.