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Biopharmaceutical Expression Systems and Genetic Engineering Technology
Bioplan Associates Inc., Nov 2008, Pages: 415
New expression systems and recent improvements available for current systems have the potential to revolutionize the biopharmaceutical industry!Lower costs and efficiencies of newer expression systems are driving these changes.
This book provides you with the information you need to make the shift to increased productivity. As reflected by currently marketed products, since the advent of genetic engineering in the 1970s, there has been little basic change in the technologies used for commercial-scale manufacture of biopharmaceutical products.
Nearly all current products are manufactured using much the same old, familiar technologies – primarily using Esherichia coli (E. coli bacterium), Chinese hamster ovary (CHO) cells and the yeast Saccharomyces cerevisiae (S. cerevisiae) as hosts – technologies invented in the 1970s and commercialized in the 1980s.
Who Should Read this Book?:
Whether you are a large or small innovator, CMO or biogenerics company and seek to develop new licensing/income streams, dream of starting a new company or simply are looking for a good investment, there are ample opportunities to get involved now, particularly before the advantages of getting involved in earlier stages of technology development and licensing are lost.
Currently, there are just a few major players promoting new technologies, and as shown in this directory, there are an incredible number of technological advances ready for adoption, adaptation and further development, providing ample opportunities for process improvements and profit.
Benefits:
Already, most major large (bio)pharmaceutical companies have made some moves in this area, with some paying millions dollars to acquire companies whose only or primary assets are new manufacturing platforms, while others are quietly but actively investigating, optioning, licensing-in and implementing new technologies.
For example, for about $400 million Merck & Co. acquired GlyoFi, a developer of methods for manufacture of antibodies with human-like and modifiable glycosylation using the yeast Pichia pastoris; and for $56.5 million, Hoffmann-La Roche acquired Therapeutic Human Polyclonals Inc., a developer of methods for manufacture of polyclonal humanized antibodies in transgenic rabbits.
The opportunities for profit are also illustrated by past technology licensing, e.g., Columbia University took in nearly $370 million over 17 years (average over $20 million/year) from licensing of co-transformation technology (see related entry) at less than a 1% royalty; Stanford University and the University of California each took in over $200 million from licensing of the Cohen-Boyer patents covering basic aspects of recombinant protein manufacture.
Coverage:
Simply stated, coverage concentrates on host cells/organisms, basic genetic engineering methods, recombinant constructs and the many technologies available to enable or improve expression of desired proteins, including glycoproteins and antibodies. This directory concentrates on the core genetic materials (e.g., host cell lines and organisms) and related methods and materials, e.g., vectors, promoters, selection and amplification methods, chaperones, etc., used or claimed useful for commercial-scale manufacture of biopharmaceutical products, primarily recombinant proteins and monoclonal antibodies. Thus, this directory concentrates only on what is used or needed for upstream manufacture.
This directory includes broad platform technologies, generally defined by the living host cells/organisms being used, which may be natural or genetically modified to begin with; and the basic genetic engineering technologies needed to get the desired gene sequence(s) into these hosts and get these genes efficiently expressed (transcribed and translated) for commercial-scale manufacture. Thus, this directory includes a number of specific genetic engineering technologies, e.g., vectors, promoters, chaperones, affinity fusion protein purification schemes, etc., useful with all, some or specific platform technologies/host systems.
Technologies involve or can be defined or viewed in many ways or on many different levels. In nearly all cases, technologies have been described in or exemplified by patents. Technologies involve know-how or enabling knowledge and related information. With biopharmaceutical manufacturing and genetic engineering technologies, this invariably involves information, e.g., methods and gene/protein sequences, often embodied in genetic constructs and culture collection deposits. In the biopharmaceutical area, just about every technology of interest has been or is in the process of being patented; and most technology acquisition or other technology transfer involves patent licensing. In many cases, all one needs to effectively acquire rights and implement a desired technology is to license related patents. In many other cases technology acquisition/licensing should involve or requires initial or even continuing technical assistance from the inventors or the organization handling licensing.
Coverage includes both technologies currently in predominant use for biopharmaceutical product manufacture, with these primarily based on use of E. coli, Chinese hamster ovary (CHO) cells and yeasts, primarily Saccharomyces cerevisiae, and new and upcoming alternative platforms/hosts, most of which have not yet been adopted/adapted for commercial-scale manufacture. Much of the older technologies, particularly those in use since the 1980s (including most E. coli, CHO and yeast technologies), have in recent years either lost or will soon lose patent protection. Many users of this directory will likely be interested in these proven, regulatory agency-familiar, cheap (now or soon no licensing expenses involved) but, in many respects, inefficient technologies. Most, if not most, directory users are presumed to be interested in new alternatives and/or significantly improving current in-house platform technologies, e.g., by adopting newer technologies offering higher yields.
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