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Scalability of a Disposable Bioreactor from 25 L-500 L Run in Perfusion Mode with a CHO-Based Cell Line: A Tech Review

by Leigh N. Pierce and Paul W. Shabram
Volume 3, Issue 4 (July/August 2004)

Single-use, disposable components offer many advantages in the manufacturing of biologics. They are clean and ready to use when supplied, which obviates the need for sterilization and decreases the requirement for services such as water for irrigation (WFI) systems and steam generators. Disposable components are not used for subsequent operations, eliminating the chance of cross contamination between process runs. Long lead times for equipment installation can be avoided because the need for stainless steel equipment is reduced or eliminated. Systems are less complex, therefore engineering requirements are also reduced. There is no need for clean-in-place (CIP) or steam-in-place (SIP) operations, along with the associated piping, valves, controls, or pressure rating of vessels. Moreover, the use of disposable components reduces the complexity of validation...

Citation:
Pierce LN, Shabram PW. Scalability of a Disposable Bioreactor from 25 L-500 L Run in Perfusion Mode with a CHO-Based Cell Line: A Tech Review.
BioProcess J, 2004; 3(4): 51-56.

 
Cell Transfection Using Calcium Phosphate Ceramic

by Patrick Frayssinet, MD, PhD and André Guilhem
Volume 3, Issue 4 (July/August 2004)

The non-viral introduction of genes into mammalian cells (transfection) is of growing interest for tissue engineering and as an alternative to the use of viral transfer of recombinant genes. The introduction of a foreign gene into cells in vivo is often limited to the use of viral vectors such as adeno or retroviruses. Viral vector may present several disadvantages or side effects that can be disastrous, and the selection of cells that are transduced by the virus is very poor. A number of non-viral vectors have been explored and used to date: lipid-based carriers, hydrogel polymers, polycationic lipids, polylysine, polyornithine, histones, and other chromosomal proteins, such as hydrogen polymers and precipitated calcium phosphate. Most of these vectors are usable in vitro but are difficult to apply in vivo, especially when local transfection to a specific cell line must be obtained...

Citation:
Frayssinet P, Guilhem A. Cell Transfection Using Calcium Phosphate Ceramic.
BioProcess J, 2004; 3(4): 57-59.

 
The ACE System: A Versatile Chromosome Engineering Technology with Applications for Gene-Based Cell Therapy

by Carl F. Perez, PhD, Sandra L. Vanderbyl, Kathleen A. Mills, PhD, Harry C. Ledebur, Jr., PhD
Volume 3, Issue 4 (July/August 2004)

Current in vivo gene therapy (GT) approaches are beginning to demonstrate significant clinical and safety limitations that may ultimately reduce their therapeutic utility. In particular, the potential for systemic toxicity due to the antigenicity of the gene transfer vector, the prospect of insertional mutagenesis/oncogenesis during gene transfer, and the possibility of germ line transfer of the transgene are issues raising concern. One promising alternative to gene therapy that mitigates these clinical and safety issues is gene-based cell therapy (GBCT), in which autologous cells are removed from a patient and modified ex vivo for a desired characteristic prior to reimplantation. By transferring the transgene ex vivo, many of the issues surrounding the in vivo use of the transfer vectors are reduced and issues surrounding germ line transfer can be practically eliminated...

Citation:
Perez CF, Vanderbyl SL, Mills KA, Ledebur HC. The ACE System: A Versatile Chromosome Engineering Technology with Applications for Gene-Based Cell Therapy.
BioProcess J, 2004; 3(4): 61-68.

 
Singapore’s Biomedical Sciences Strategy

by Beh Swan
Volume 3, Issue 3 (May/June 2004)

Singapore’s vision is to become a global hub for the biomedical sciences (BMS) with world-class capabilities ranging from basic and clinical research to manufacturing and healthcare delivery. This vision encompasses pharmaceuticals, biotechnology, medical technology, and healthcare services. Singapore’s BMS initiative was launched in June 2000 with the goal of developing the industry into a key pillar of Singapore’s economy. It is overseen by a Ministerial Committee chaired by Deputy Prime Minister Dr. Tony Tan and implemented by an executive committee led by Mr. Philip Yeo, who is chairman of the Agency for Science, Technology, and Research (A*STAR) and co-chairman of Singapore’s Economic Development Board (EDB)...

Citation:
Swan B. Singapore’s Biomedical Sciences Strategy.
BioProcess J, 2004; 3(3): 20-21.

 
Zoonoses: A Stimulus for Wider Research and Consideration in Product Development

by Mark Plavsic, DVM, PhD
Volume 3, Issue 3 (May/June 2004)

The last decade witnessed remarkable scientific and technological advances in a number of scientific disciplines, including cell biology, microbiology, molecular biology, oncology, virology, infectious diseases, diagnostic technologies, analytical chemistry, instrumentation, and informatics. These advances have had a major impact on medicine, which has experienced fantastic progress in improving disease diagnosis, treatment, and overall patient care. Despite the advances in developing ever more sophisticated technologies and increasing the understanding of disease, new maladies continue to emerge. This is especially true for infectious ailments. Despite great developments in epidemiology, diagnostics, and agent detection technologies, as well as a comprehensive understanding of the biology of many known infectious agents and their virulence factors, we also are witnessing a dramatic increase in the number of new agents and diseases....

Citation:
Plavsic M. Zoonoses: A Stimulus for Wider Research and Consideration in Product Development.
BioProcess J, 2004; 3(3): 23-29.

 
Single Protocol for the Selective Isotopic and Chemical Labeling of Protein Kinases in Insect Cells for NMR and Crystallographic Studies

by Cinzia Cristiani, Sandrine Thieffine, Silvia Messali, Luisa Rusconi, Arndt Schnuchel, PhD, and Henryk M. Kalisz, PhD
Volume 3, Issue 3 (May/June 2004)

The human protein kinase superfamily is one of the largest and most important families of enzymes. More than 500 distinct kinases, classified in about 20 families on the basis of their primary structure similarity, have been identified to date. Protein kinases regulate a variety of biochemical pathways in cells through phosphotransfer reactions, playing pivotal roles in most signaling and regulatory processes, such as gene expression, proliferation, cell motility, and angiogenesis. Deregulation and/or mutational modification of protein kinase activity, leading to aberrant protein phosphorylation, is implicated in a variety of diseases, particularly cancer, making protein kinases important drug targets. A number of specific protein kinase inhibitors has been developed recently and more than 30 compounds are currently in clinical development or on the market. Many of these inhibitors are small-molecule compounds that compete with ATP for the highly conserved ATP binding site of the kinases. The development of highly selective and potent ATP-competitive inhibitors is driven by structure-activity relationship (SAR) studies, with X-ray crystallography and nuclear magnetic resonance (NMR) spectroscopy playing an important role in the understanding of the mechanism of inhibitor binding to the active or inactive forms of protein kinases...

Citation:
Cristiani C, Thieffine S, Messali S, Rusconi L, Schnuchel A, Kalisz HM. Single Protocol for the Selective Isotopic and Chemical Labeling of Protein Kinases in Insect Cells for NMR and Crystallographic Studies.
BioProcess J, 2004; 3(3): 31-37.

 
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