Spring Intro 2023

06/03/2023

Overview

• What is a biotechnology product

• Key regulatory aspects to consider

• Filing Biotechnology Products

• Advanced Therapy Medicinal Products

• Hot Topics and Conclusions

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What is a biotechnology product?

• In 1919, Hungarian agricultural engineer Karl Ereky coined the term biotechnology to describe that merging of biology and technology.

• Biotechnology products means those products that are applicable to the prevention, treatment, or cure of a disease and that are produced using living organisms, materials derived from living organisms, or cellular, subcellular, or molecular components of living organisms.

1. Amgen Biotechnology and Human Therapeutics Fact Sheet. 2006 2. BIO 2005 – 2006. Guide to Biotechnology

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