The production and use of monoclonal antibodies (mAbs) in the in-vivo diagnosis and treatment of human diseases has evolved exponentially in recent years. This course, a Zenosis® eLearning module, identifies the key manufacturing issues and concerns associated with mAb production. Participants will learn about the setting of specifications; requirements on preclinical and clinical studies; special requirements for radio-labeled mAbs; and orphan drug status and its effect on clinical design. Also covered are procedures for making regulatory submissions for mAbs in both Europe and the United States. In addition, the module reviews the impact of recent developments in production techniques on the regulatory landscape.
The module takes an average of 3 hours to complete. (Note that this is an average time. People learn at different rates, and they explore resources and examples at different paces.)
- Manufacturing considerations in mAb production
- EU legislative framework
- US legislative framework
Who should attend?
- Those working the research and development of monoclonal antibodies
- Clinical trials or regulatory affairs personnel or those preparing regulatory submissions
- Personnel involved in the registration of monoclonal antibodies
Participants who complete this course should be able to:
- Identify the regulatory requirements and pathways to licensure in Europe and the United States
- Recognize and apply the relevant studies to develop safe and effective mAb products