Recently BioNTech has acquired Novartis plant in Marburg for large scale manufacturing of Corona vaccines. This current approach represents innovative but also risky procedure since vaccine candidate must be approved and production line must be inspected by authorities (US FDA, local authorities in Europe)

In order to receive authorial permission to produce this vaccine, several things must be performed to establish GMP compliance. These aspects are then subject of authorial inspection representing prerequisite for receiving manufacturing License.

In this seminar you will learn all relevant issues to qualify a production plant for pharmaceuticals based on this prominent case study for large scale mRNA vaccine manufacturing. This theoretical approach will illustrate authorial requirements for pharma production and general drug approval.

Teaching goals [printed on certificate]:

• approval of pharmaceuticals (vaccines) in clinical trials

• from pilot scale to large scale

• qualification of large scale production to GMP compliance (vaccines)