Upstream Process Development (UPD) is essential to ensure robust, scalable processes that can efficiently bring biotherapeutics to market. However, challenges such as optimizing yield, ensuring ...

The optimization of processes for the development and manufacture of biopharmaceuticals is pivotal for producing quality products. The development and production of biologics can be a complex process.

Further to Decision 46 COM 9A, this document presents a report on the implementation of the Upstream Process requests since the 46th session of the World Heritage Committee (New Delhi, 2024). It also ...

Biopharmaceutical production faces the challenge of ensuring the quality of raw materials due to a lack of specific guidelines. By implementing effective risk assessment strategies and working with ...