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Regulatory Aspects of Recombinant Protein Products by Baculovirus Expression Systems

by Daniel Galbraith, PhD
Volume 1, Issue 2 (Summer 2002)

The baculovirus expression system promises to revolutionize the production of recombinant proteins for use as clinical products. The technology is robust, efficient, and low-cost when compared to other cell based systems. The technique may also present an advantage in producing safer products versus the equivalent materials made with mammalian cells. Proteins can be produced in insect cells without animal supplements such as fetal calf serum. In the current climate of concerns over Bovine Spongiform Encephalopathies, and bovine viral risks, this method offers a significant safety, as well as cost advantage, over other production methods...

Galbraith D. Regulatory Aspects of Recombinant Protein Products by Baculovirus Expression Systems. BioProcess J, 2002; 1(2): 47-51.

Production of a p55gag Particle Vaccine Using the Baculovirus Expression Vector System Technology

by Penny L. Post, PhD and Manon M.J. Cox
Volume 1, Issue 2 (Summer 2002)

Globally, an estimated 36 million people are living with HIV, and some 20 million people have already died of AIDS. Today, there is still no HIV vaccine available. HIV virus-like particles are an attractive vaccine candidate due to their ability to induce both antibody and cytotoxic T-lymphocyte responses. In this article, we describe the development of a production process for an HIV particle vaccine, HIV-1 p55 (gag). The gag precursor protein (p55) is sufficient for assembly and cellular release of retrovirus-like particles. We expressed the p55 gag protein using the BEVS technology in Spodoptera frugiperda expresSF+ cells...

Post PL, Cox MMJ. Production of a p55gag Particle Vaccine Using the Baculovirus Expression Vector System Technology. BioProcess J, 2002; 1(2): 52-59.

Apoptosis in Biotechnology: Its Role in Mammalian Cell Culture and Methods of Inhibition

by Tina M. Sauerwald, PhD and Michael J. Betenbaugh, PhD
Volume 1, Issue 2 (Summer 2002)

Apoptosis is an essential biological process that has been conserved among eukaryotic organisms throughout evolution. Apoptosis, or programmed cell death, is necessary for embryological development, tissue homeostasis, immune system maintenance and development, and as a defense mechanism against the progression of cancer and viral infection. With the advent of biotechnology and the development of associated molecular biology techniques such as recombinant DNA technology and mammalian cell culture, tissues can be extracted from organisms and have their cells cultured as single cell suspensions or adherent monolayers. Therefore, these cultures can function as living production facilities for antibodies, recombinant glycoproteins, vaccines, hormones, growth factors, and more. However, the cell's ability to control its own death is not lost upon its manipulation from the organism to culture. Consequently, apoptosis, which is so fundamentally important in-vivo, becomes a detriment to biochemical manufacturers in-vitro...

Sauerwald TM, Betenbaugh MJ. Apoptosis in Biotechnology: Its Role in Mammalian Cell Culture and Methods of Inhibition. BioProcess J, 2002; 1(2): 61-68.

The Road Ahead for Biologics Manufacturing

by Peter L. Ginsberg, Sandeep Bhatia, PhD, and Rachel L. McMinn, PhD
Volume 1, Issue 1 (March 2002)

Protein-based therapeutics have led to the emergence of the biotechnology industry and should drive rapid growth in the industry over the next decade. In 2001 alone, six major biologics were approved by the FDA. According to our analysis, there are 39 biologic products (antibodies and non-antibody recombinant proteins) that are currently in Phase III clinical testing and about 60 in Phase II testing, which we estimate could lead to 34 new products on the market in the next four to six years. By our estimates, such a new product outpouring would lead to more than a doubling of the number of profitable biopharmaceutical product companies (currently 15) by mid-decade. The focus of this report is to evaluate the manufacturing aspects of biotechnology models and analyze the current and future capacity needs of the industry...

Ginsberg PL, Bhatia S, McMinn RL. The Road Ahead for Biologics Manufacturing. BioProcess J, 2002; 1(1): 19-21.

Industry Observations and Perspectives Part I

by Keith L. Carson
Volume 1, Issue 1 (March 2002)

Baculovirus expression technology, or BEVS, gained its first broad industry exposure in the early 1980s, primarily through the many papers published by students and post-doctoral fellows in Dr. Max Summers' laboratory at Texas A&M University (College Station, Texas). This technology fostered popular appeal because of its simplicity and high protein expression capabilities. As more work was done, it became even more evident that this was a very rapid, and relatively inexpensive method for producing proteins. It was also postulated that BEVS would offer a valuable means of producing recombinant proteins for use in human therapy, especially since baculovirus was considered non-infectious to human cells. It was thought that any problems with post-translational modifications of the manufactured proteins could be worked out, and fully functional glycoproteins could be manufactured...

Carson KL. Industry Observations and Perspectives Part I. BioProcess J, 2002; 1(1): 22-24.

Development of a Reference Material for Characterizing Adenovirus Vectors

by Beth Hutchins, PhD
Volume 1, Issue 1 (March 2002)

The development of reference testing reagents has been used successfully in the past to standardize measurements among laboratories, particularly for biological products such as recombinant cytokines. This approach was recommended by many parties with a stake in adenovirus vector delivery in order to address the fact that particle units and infectious units are not standardized in the field. This has made interpretation of preclinical and clinical data, as it relates to the amount of adenovirus vector administered, difficult to compare across the field. An Adenovirus Reference Material is being developed to define the particle unit and infectious unit for adenovirus gene vectors, and create a commonality for comparisons, especially for data related to vector safety...

Hutchins B. Development of a Reference Material for Characterizing Adenovirus Vectors. BioProcess J, 2002; 1(1): 25-29.

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