EMA Approves Scale-Up Process for Janssen COVID-19 Vaccine
The approved changes to the API manufacturing plant in Leiden, the Netherlands will enable an increase in API capacity.
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
EMA Recommends Imfinzi-Based Perioperative Regimen for Treating Resectable NSCLC
March 10th 2025The committee’s recommendation is based on results from a Phase III trial in which Imfinzi demonstrated a reduced risk of recurrence, progression, or death by 32% compared to neoadjuvant chemotherapy alone.
International Women’s Day 2025: A Promising Future for Gender Diversity in Pharma
March 8th 2025In an interview with BioPharm International®, Sheryl Johnson from Orbia Fluor & Energy Materials chats about gender diversity, how women are helping to advance innovation, sustainability challenges, and progress in the field of inhaled drugs.
