Early Biotechnology Production of Human Cytokines and Hormones

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Over the past 20 years, the biotechnology industry has been extraordinarily successful in bringing a wide variety of new products to the market. It is often perceived that the biotechnology industry has been faster than the traditional pharma industry in bringing products to the market. However, the list (from insulin through growth hormones and gonadotrophins, to EPO) shows that the road in the early days was often long and difficult, and started from an 'in vivo' demonstration of activity using crude extracts (Fig. 17.2). Indeed, the majority of the early products of biotechnology were proteins from natural sources (insulin, growth hormone) purified based on biological activity; subsequent protein sequencing was obtained, thus allowing cloning from cDNA libraries only when the recombinant DNA technology became available in the late 1970s. The triumph of the biotech industry has been in finding ways to produce the molecules on a large scale, and at a quality that allows their safe administration to humans (Fig. 17.3a).

In the mid 1990s, large amounts of data from expressed sequence tag projects (Wells and Peitsch 1997; Yee and Conklin 1998) became publicly available, allowing us to rapidly identify homologous sequences or little brothers of the known cytokines. Now the scientific challenge had been turned on its head - in the early days finding the sequence was the difficult part. Now the challenge is to find the biological activities for orphan sequences that look like cytokines.

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Fig. 17.3. The market size for existing biotech products and projected markets over the next 3 years. a Most of the power of the biotechnology industry comes from classic products - molecules which were first identified by their biological activities, and then cloned and produced. b The second wave is the development of monoclonal antibodies, enabling us to block key responses, and leading to several blockbuster products. The commercialization of the genome era cytokines will follow on afterthis wave, with molecules such as TACIIG in the vanguard

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Fig. 17.2. Timelines for the development of new proteins as therapeutics. Prior to 1995, all therapeutic proteins had been identified based on their biological activities and cloned. TACI represents a new generation of proteins, identified based on sequence with the biological activity determined afterwards. This has been a much faster route, although arguably with a much higher rate of attrition (there are still relatively few success stories). TREM-1 triggering receptor expressed on myeloid cells, BCSP-1 bone and cartilage stimulating peptide-1

17.4 Assembling the Complete Protein Collection: The Serono Secretóme 177

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