This module identifies the key manufacturing issues and the concerns associated with mAb production. Setting of specifications is also discussed. Requirements on preclinical and clinical studies are set out. Special requirements for radio-labelled mAbs are described. Procedures for making regulatory submissions for mAbs are detailed: marketing authorisation application through the Centralised Procedure (CP) in Europe, and by a Biologics License Application (BLA) in the USA. Orphan drug status and its effect on clinical design are addressed. The module discusses the impact of recent developments in production techniques on the regulatory landscape and will serve as an effective reference source on future developments and their practical consequences.
Who will benefit from this module?
Individuals working on the research and development of monoclonal antibodies, on clinical trials, in regulatory affairs, or otherwise involved in the preparation of regulatory submissions. Those needing to improve their understanding of monoclonal antibodies for registration will find this module invaluable.
- Identify the regulatory requirements and pathways to licensure in the EU and USA.
- Recognise and apply the relevant studies and developmental aspects to be conducted, critical to establishing safe and effective mAb products
CPD Points: 3
Assessment: Multiple-choice mastery assessment
EU regulatory applications - This session considers the regulatory equirements and pathways in the EU.
US regulatory applications - This session considers the regulatory requirements and pathways in the USA.
Manufacturing issues - This session discusses key manufacturing issues in the development of mAb products.
Setting specifications - This session outlines the tests conducted and appropriate acceptance criteria or test results required to establish specifications to which a drug substance and drug product should conform to be considered acceptable for use in humans.
Preclinical issues - This session discusses key preclinical issues in the development of mAb products.
Clinical issues - This session emphasises developmental aspects crucial to the creation of safe and effective mAb products.
Radio-labelled mAbs - This session identifies the investigational studies on mAbs essential for successful marketing authorisation.
MAbs as orphan drugs - This session provides a basic understanding of the concepts which apply to the registration of mAbs in the European Union and USA.