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Bioprocesses of Biopharmaceuticals - The Obligatory Role of Post Translational Modifications to Create Functional Bioactive Molecules
Drug and Market Development Publishing, Dec 2005
During the past two decades, biopharmaceuticals have advanced the prevention and treatment of many serious diseases, and also contributed to the continued success of the pharmaceutical industry. Biopharmaceuticals have shorter development times than chemically synthesized drugs NCEs and the ability to clone, manipulate and express proteins in high concentrations has facilitated the development of biotechnology based drugs.
Nearly all products introduced during the 1980s underwent major improvements in production, purification and formulation after reaching the market. Somatostatin was the first (1970s) protein expressed via genetic engineering using E. coli. In 2003, somatostatin garnered approximately $1.4 billion in global sales.
Meeting future needs will be more complicated than merely expanding existing capacity. Although biologics manufacturing now is focused chiefly on a small number of blockbuster products, the future challenges will involve the ability to gear up for the production of a larger variety of products with lower sales volumes.
This study looks at all protein drug manufacture, starting with choice of methods and scale-up processes, especially by highlighting important post translational modifications such as glycosylation.
Overview
Taking a bioactive molecule from its functional domain and injecting it into a human being for therapeutic benefits involves a merger of intricate cutting edge technology, basic molecular science and an 'art'(cell culture being a notorious bottle neck particularly in up scaling processes).
This publication explains the complicated biological processes that must be harnessed to achieve the required functionality of the bioproducts by explaining the molecular biology involved - starting at a basic level and reaching the state of art known today.
Recently, the productivity of mammalian cells cultivated in bioreactors has reached the gram per litre range in a number of cases, a more than 100-fold yield improvement over titers seen for similar processes in the mid-1980s. Opportunities still exist for improving mammalian cell systems through further advancements in production systems as well as through vector and host cell engineering and appropriate post translational modifications.
- Detailed explanations highlighting the science and the steps involved in selecting the appropriate cell culture systems, scaling up the processes as required whilst monitoring the post translational modifications and the monitoring of the eventual final products by several new technologies are provided with emphasis on illustrating the commercial use of industrial processes.
- Extensive descriptions of FDA approved products - their history and their clinical efficacies are used to illustrate numerous bottlenecks and the attempts made to modify them appropriately.
- The potential rise of biogenerics, the demise of several important patents and the overall regulatory environment that has just begun to emerge are described at length in this publication.
Market Opportunities
The growing demands for existing biologics production are reflected in biopharmaceutical sales figures: the top 15 products in 2004 posted revenues of $38 billion.
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