The age of biopharmaceuticals

The first stages of development of the modern pharmaceutical industry can be traced back to the turn of the twentieth century. At that time (apart from folk cures), the medical community had at their disposal only four drugs that were effective in treating specific diseases  

This lack of appropriate, safe and effective medicines contributed in no small way to the low life expectancy characteristic of those times. 

The medical success of these drugs gave new emphasis to the pharmaceutical industry, which was boosted further by the commencement of industrial-scale penicillin manufacture in the early 1940s. Around this time, many of the current leading pharmaceutical companies (or their forerunners) were founded. Examples include Ciba Geigy, Eli Lilly, Wellcome, Glaxo and Roche. Over the next two to three decades, these companies developed drugs such as tetracyclines, corticosteroids, oral contraceptives, antidepressants and many more. Most of these pharmaceutical substances are manufactured by direct chemical synthesis. 

Biomedical research continues to broaden our understanding of the molecular mechanisms underlining both health and disease. Research undertaken since the 1950s has pinpointed a host of proteins produced naturally in the body that have obvious therapeutic applications. Examples include the interferons and interleukins (which regulate the immune response), growth factors, such as erythropoietin (EPO which stimulates red blood cell production), and neurotrophic factors (which regulate the development and maintenance of neural tissue). 

Recombinant DNA technology has had a fourfold positive impact upon the production of pharmaceutically important proteins  

It overcomes the problem of source availability. Many proteins of therapeutic potential are produced naturally in the body in minute quantities. Examples include interferons (Chapter 4), interleukins (Chapter 5) and colony stimulating factors (Chapter 6). This rendered impractical their direct extraction from native source material in quantities sufficient to meet likely clinical demand. Recombinant production (Chapter 3) allows the manufacture of any protein in whatever quantity it is required. 

It overcomes problems of product safety. Direct extraction of product from some native biological sources has, in the past, led to the unwitting transmission of disease. Examples include the transmission of blood-borne pathogens such as hepatitis B, C and HIV via infected blood products and the transmission of Creutzfeldt-Jakob disease to persons receiving human growth hormone preparations derived from human pituitaries. 

Faster-acting insulins (Chapter 8) Slow-acting insulins (Chapter 8) Modified tissue plasminogen activator (tPA Chapter 9) 

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Figure 18.1 Study design for the pre- and postnatal development evaluation in the cynomolgus monkey. Maternal treatment is either discontinued at term or is continued into the lactation period in order to investigate transfer of test item to the infant. Transfer of biopharmaceuticals via milk has been observed in this species. The duration of the postnatal observation period is variable and not yet standardized. In our laboratory the longest postnatal observation period covered 720 days. A variety of parameters is available for testing infant development (see also Table 18.4 for details). For biopharmaceuticals, a minimum period of 6 months appears appropriate. If the behavioral test battery comprises learning tests that are recommended from the age of 6 months onward, infants should be observed for at least 9 months.

As the biotechnology industry comes of age, and protein-based therapeutics become a practical reahty, the importance of protein-stabilizing technologies comes increasingly to the fore. The therapeutic efficacy of many of these biopharmaceuticals is impeded by the hosts natural immune defense system [23]. When a host encounters a foreign protein in its circulation, the hosts immune system initiates an immune response, which results in the production of protein-inactivating antibodies that dear the protein from the circulation. When the immune system develops an abihty to inactivate the protein, the therapy becomes ineffective. Hence, to counteract... 

I ) Healthcare Trends and their impact on the Biopharmaceutical Industry Biopharmaceuticals Come of Age the vanguard of pharmaceutical innova- 1.4.1... 

We all know that since the remarkable debut of modern biopharmaceuticals , the field of pharmaceutical biotechnology has evolved tremendously. By comparison, when I follow how quickly (life) sciences advance, it would make Newton s apple appear to fall in slow motion. I am very happy that people who contributed most to this fast and exciting development of biopharmaceuticals, who helped to usher in a golden age of molecular biology, also contributed to Modern Biopharmaceuticals -Design, Development and Optimization. 1 would like to take the opportunity to thank all of the authors for their excellent contributions and hope that the reader will enjoy this fantastic collection of scientific art. 

I 7 Healthcare Trends and their Impact on the Biopharmaceutical Industiy Biopharmaceuticals Come of Age... 

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