TGN BIOTECH: A START-UP WITH ETHICAL ROOTS

The chapter examines how TGN Biotech (TGN) will become a leader in biological therapeutic production. TGN Biotech's goal is to become a public company and in the process create numerous highly skilled employment opportunities, both in research and in business development, expanding into newly defined fields and markets. TGN has an important partnership with Laval University, because TGN's two founders are still full-time professors in the animal sciences department of the University. TGN has a contract with the University to sponsor research in their laboratories in return for rights to license the technology. Recombinant proteins are a growing share of the biotech sector, with more than 50 approved products currently in the market. There are also more than 500 products in the development pipeline but, under current production methods, worldwide manufacturing is close to capacity. TGN is currently working on three proteins that have an estimated market value of US$1 billion. Although the company has not yet released what these proteins are, all three will become the raw material for biogeneric products. TGN has a full-time Regulatory Assurance Director to communicate with regulators, and a full-time Quality Assurance Director to ensure that internal quality control is developed at the same time as the science.