QRM Tools for Contract Biomanufacturing

Contract development and manufacturing organizations (CDMOs) are more critical than ever as the demand for advanced therapies continues to grow.

Hanns-Christian Mahler and Andrea Allmendinger from ten23 health will discuss some key aspects of biologic drug development and manufacturing.

EMA's committee gave recommendations for marketing authorization of 17 drugs in December, which include therapies for rare heart conditions, anemia, and liver disease.

The European Commission’s approval of the Catalent acquisition by Novo Holdings includes the related acquisition of three manufacturing sites by Novo Nordisk, which is also acquiring the Czech Republic manufacturing site of Novavax for $200 million.

With so many personnel involved in the development and manufacture of pharmaceuticals, proper training of all staff is key to ensuring a quality product.

Many factors must be considered to overcome the challenges associated with viral clearance.