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Quality Control, Preparation, and Protein Stability Issues for Blood Serum and Plasma Used In Biomarker Discovery and Proteomic Profiling Assays

by Richard R. Drake, PhD, Lisa H. Cazares, Alberto Corsica, MD, Gunjan Malik, PhD, E. Ellen Schwegler, Alisa E. Libby, George L. Wright, Jr., PhD, Bao-Ling Adam, PhD, and O. John Semmes, PhD
Volume 3, Issue 4 (July/August 2004)

There is an increasing emphasis in clinical and translational research on the discovery and development of biomarkers that are indicative of a disease state. While biomarkers are not exclusively proteins, the emergence of new mass spectrometry platforms combined with the human genome databases has rejuvenated the search for biomarker proteins, especially in readily available body fluids such as blood. There is currently a tremendous need for an improved ability to "mine" the full depth of the proteome in a high throughput manner. To advance clinical proteomics, methodologies are needed that can accommodate higher throughput while facilitating the ability to observe large numbers of protein events...

Citation:
Drake RR, Cazares LH, Corsica A, Malik G, Schwegler EE, Libby AE, Wright GL, Adam B, Semmes OJ. Quality Control, Preparation, and Protein Stability Issues for Blood Serum and Plasma Used In Biomarker Discovery and Proteomic Profiling Assays.
BioProcess J, 2004; 3(4): 45-50.

 
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.

 
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