EMA Approves Scale-Up Process for Janssen COVID-19 Vaccine

The European Medicines Agency (EMA) announced on July 2, 2021, that the agency’s committee for human medicines (CHMP) has approved scale-up of API manufacturing at the Janssen Biologics B.V. plant located in Leiden, the Netherlands. The plant produces all API for Janssen’s COVID-19 vaccine supply in the European Union and is expected to continue to supply the vaccine for the EU.

The scale up of the facility includes a new building, new equipment, and additional process optimizations. The approved modifications are anticipated to increase API manufacturing capacity. EMA states that the recommendation does not require a decision from the European Commission; therefore, the new building can immediately become operational.

Source: EMA