Module 9 2021

Biologicals Old, new, high tech, low tech

• “Traditional” Biological Products – vaccines, serums – allergens, extracted hormones – blood products

• Biotech Products (1 st generation) – r-hormones, vaccines, thrombolytics – r-interferons, cytokines, haematopoietic factors – monoclonal antibodies

• Biotech Products (2 nd generation) – biosimilars

– gene therapy products – nucleic acid products – therapeutic vaccines

The Organisation for Professionals in Regulatory Affairs

3

Biological Medicinal Product Definition*

A product, the active substance of which is a biological substance

• Produced by or extracted from a biological source, such as – Micro-organisms, organs and tissues of either plant or animal origin – Cells or fluids (including blood or plasma) of human or animal origin – Biotechnological cell constructs (cell substrates, whether they are recombinant or not, including primary cells) • … and for which a combination of physico-chemical-biological testing and the production process and its control is needed for its characterisation and the determination of its quality.

* Part I of Annex I of Directive 2001/83/EC

The Organisation for Professionals in Regulatory Affairs

4

2