COVID-19 Vaccine Critical Process Operations and Key Quality Attributes


Cell Bank Development & Validation

All vaccine candidates require cell bank development and validation for production of protein, mRNA, or viral vectors.

Upstream Production

Cell Culture

Growth of the cell line at commercial scale for production of the vaccine or vaccine components. Cells may be continuously producing the biologic component or be induced to produce it.

Purification Bulk

Vaccine components are purified from the cell culture. The purification process usually consists of two or more steps.

Vaccine Preparation

Post purification, the bulk vaccine may be concentrated and buffers or stabilizers may be added.

Downstream Production

Final Compounding

Dilution of the vaccine to the final strength that will be administered. Stabilizers, buffers, or adjuvants may also be added during final compounding.

Aseptic Filtration

The compounded formulation is filtered to remove any bacterial contaminants.


Final step in the production of the product. The vaccine is aseptically filled into the final container.

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.