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Facility Limitation Considerations for Filling Pandemic Vaccine

Specifications for Manufacturers to Prepare to Produce Billions of Doses of COVID-19 Vaccine

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.

You may be interested in the following article:

A Comparative Framework Between New Product and Legacy Product Process Validation

This paper is a comparative analysis between the application of the FDA Process Validation Guidance (2011) to new products and legacy products.