About this document
Adventitious Agents Safety in Denosumab by marisanchezch21 is a document available to read on EtoBox.
The document evaluates the safety of adventitious agents in the biotechnological medicinal products RGB-14-P and RGB-14-X, focusing on the raw materials of biological origin used in the manufacture of denosumab. It includes assessments of TSE agents, viral safety, and the effectiveness of downstream processing in clearing infectious viruses. The document also details the identification and characterization of materials used during cell line development and the manufacturing of master and working cell banks.
- Author
- marisanchezch21
- Language
- EN