Scalable rubella production in scale-X™ bioreactor with MRC-5 cells

Deployment of scalable serum-free perfusion process within an automated solution

The traditional technologies such as static flasks or microcarriers in stirred tank bioreactors present several limitations in capacity, reliability and scalability used in vaccine production. New fixed-bed bioreactors were introduced to the market offering a scalable commercial solution. Today, technology innovation has enabled further improvements reaching automated and simplified bioprocessing with increased batch-to-batch reproducibility.

This study demonstrates the successful transfer, optimization and scale-up of rubella vaccine manufacturing process from static flask to the structured fixed-bed scale-X™ bioreactor range.

Direct transfer and process optimization in structured fixed-bed scale-X bioreactors - Univercells Technologies

First, a direct process transfer was performed in the scale-X hydro bioreactor to reach a similar cell growth profile compared to static flasks. Next, the aim was to improve the process to optimize media consumption, implement perfusion and obtain a serum-free process. Then, the successfully obtained serum-free perfusion process was scaled-up to the scale-X carbo 10 m² and 30 m² cell growth surface bioreactor.

Successful contribution to filling the antigen gap for rubella vaccination efforts

Global rubella immunization campaigns are pulled back due to insufficient availability of affordable vaccines. The worldwide production of Measles, Mumps and Rubella (MMR) vaccine presents an annual shortage of around 200 million doses to meet routine and campaign requirements. The reached rubella production in the scale-X carbo 30 bioreactor predicts the possibility to obtain 1 million doses per batch (check assumptions in application note).

Depending on the intended target, the process obtained could be further scaled-up to the scale-X nitro 600 – integrated into the NevoLine™ Upstream platform – resulting up to 20.6 million doses per batch.

Such results establish the structured fixed-bed scale-X technology as an unparalleled, cost-effective solution answering the global demand of rubella vaccine production.

Download the Application Note

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