Module 9
Registration of Biological, Biotechnology and Advanced Therapy Products
Aim
The purpose of this Module is to enable students to study and understand the scientific principles underpinning development of biological/ biotechnology products and how the inherent complexities impact on regulation.
Aim
The aim of this module is to enable students to understand the regulations applicable to Biological, Biotechnology and Advanced Therapy products and how the inherent complexities impact on their regulation.
Learning outcomes
- Students will discriminate the differences between a biological and a chemical entity and will recognise and interpret the complex nature of biological/biotechnology products.
- Students will appraise the quality issues specific to biologicals, for example potential virus contamination, assay by bioassay.
- Students will analyse the implications of change in production process on product and the concept of comparability.
- Students will differentiate different classes of biological products such as vaccines, monoclonal antibodies and gene therapy and the data requirements specific to these products.
Outline of Module topics
- What is a biological? How are they regulated?
- Characterisation and quality control
- Implications for change in process on product development
- Preclinical requirements
- Clinical development of biotech products
- New technologies, for example gene therapy, and how they are regulated
- Biosimilar products
Outline of Module topics
- Module 1 covers global regulatory strategy.
- Modules 2-5 cover quality, safety and efficacy aspects of the regulatory strategy for a new active substance.
