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Biological Packaging for the Global Cell and Tissue Therapy Markets

by Kristi K. Snyder, Robert G. Van Buskirk, PhD, Aby J. Mathew, PhD, John G. Baust, PhD, and John M. Baust, PhD
Volume 3, Issue 3 (May/June 2004)

The globalization and sustained growth of the biotechnology market has brought the issue of biological packaging to the fore, particularly for those companies invested in cell and tissue bioproducts, such as engineered tissues and cells used for cell therapy. Biological packaging can be defined as the sum total of the physical device, temperature regulating and monitoring systems, type of preservation solution, and storage protocol(s) necessary to maintain cells or tissues in a “state of suspended animation” during transport or storage. The ideal biological package provides for the transport of cells and tissues throughout the global marketplace while maintaining both the viability and the function of the biological system at levels equivalent to those measured prior to shipment. Cells and tissues are currently shipped and stored under hypothermic (4–8ºC) or cryopreserved (–80 to –196ºC) conditions. These two processes have remained relatively unchanged over the past several decades, limiting their utility in the storage of modern bioproducts. However, recent evolutions in biological packaging have begun to provide scientific and financial benefits to researchers, clinicians, and corporate entities...

Snyder KK, Van Buskirk RG, Mathew AJ, Baust JG, Baust JM. Biological Packaging for the Global Cell and Tissue Therapy Markets.
BioProcess J, 2004; 3(3): 39-45.

A Flow Cytometric Assay for Rapid, Accurate Determination of Baculovirus Titers

by Thera Mulvania, PhD, Brooks Hayes, and David Hedin
Volume 3, Issue 3 (May/June 2004)

Recombinant protein expression using the Baculovirus Expression Vector System (BEVS) is a powerful tool for the production of therapeutics, diagnostics, and reagents. To maximize efficiency of protein production, and thereby reduce costs, it is important to optimize the production parameters. A crucial step in optimization is determining the best multiplicity of infection (MOI) for the system in use. Factors that can affect the MOI include the recombinant baculovirus itself as well as cell line type and media composition. Typically the titer of a viral stock is determined in a standard manner, and then that titer is applied to each and every parameter tested; for instance, titering the virus on a Spodoptera cell line in a serum-containing media, and then using those data to determine the MOI used to infect Trichoplusia cells in a serum-free media formulation. The results may suggest that either the Trichoplusia cell line or the media formulation is inadequate for protein expression when, in fact, the MOI was incorrect for that particular combination...

Mulvania T, Hayes B, Hedin D. A Flow Cytometric Assay for Rapid, Accurate Determination of Baculovirus Titers.
BioProcess J, 2004; 3(3): 47-53.

Integration of Centrifuges with Depth Filtration for Optimized Cell Culture Fluid Clarification Processes

by Michel Pailhes, Charles Lambalot, and Robert Barloga
Volume 3, Issue 3 (May/June 2004)

One of the biggest challenges in the production of recombinant therapeutic proteins, monoclonal antibodies, and vaccines is the clarification and separation of the product (typically a protein) from the cell culture or fermentation broth. The desired product is present in low concentrations and must be efficiently separated from the other components present in the bioreactor fluid. An overall objective in developing a clarification process is to achieve the highest level of product recovery (yield) and contaminant removal with the fewest number of unit processes. Understanding how each operational step affects the performance of the next step downstream is the challenge at hand. Centrifugation, in combination with depth filtration, is gaining acceptance as the preferred method for the removal of cells, cell debris, colloids, insoluble precipitants, aggregates, and other materials found in mammalian cell culture and bacterial fermentation fluids...

Pailhes M, Lambalot C, Barloga R. Integration of Centrifuges with Depth Filtration for Optimized Cell Culture Fluid Clarification Processes.
BioProcess J, 2004; 3(3): 55-58.

Cell Engineering Blocks Cell Stress and Improves Biotherapeutic Production

by M.J. Betenbaugh, PhD, N. Arden, and T. Nivitchanyong
Volume 3, Issue 2 (March/April 2004)

Within the biopharmaceutical industry, mammalian cell culture is extensively used to manufacture a various biopharmaceutics uncluding antibodies, interferons, hormones, crythropoietin, clotting factors, immunoadhesins, and vaccines. The market for monoclonal antibodies (MAbs) alone is expected to grow 30% a year and reach sales of nearly $6.5 billion in 2004. The vast majority of these biotherapheutics are secreted glycoproteins obtained from mammalian cell lines such as: Chinese hamster ovary (CHO), human embryonic kidney 293 (HEK-293 or 293). NS0, and baby hamster kidney (BHK). As is the goal with most commercial products, biotechnologists strive to generate thesee valuable proteins in the highest yields possible in order to utilize mammalian bioreactor facilities efficiently...

Betenbaugh MJ, Arden N, Nivitchanyong T. Cell Engineering Blocks Cell Stress and Improves Biotherapeutic Production. BioProcess J, 2004; 3(2): 23-28.

Investing in Process Development

by Geoffrey Hodge
Volume 3, Issue 2 (March/April 2004)

Process development is an investment. As with a personal retirement plan, the importance of making the investment is not in question, yet strategies for when, how much, and where to invest in process development vary significantly from company to company. For a personal retirement plan, the answers to these questions are straightforward: invest as early as you can and as much as you can, and take less risk the closer you get to retirement. This would also be sound advice for investing in process development (substituting “BLA filing” for “retirement”) were it not for two complicating factors. First, the majority of biotherapeutics that enter the clinic fail to make it to the market. This makes a large, early investment in process development less attractive. Second, there is extreme pressure to get into the clinic, and subsequently onto the market, as quickly as possible, minimizing the time available for process development...

Hodge G. Investing in Process Development. BioProcess J, 2004; 3(2): 31-35.

Biotherapeutics from Transgenic Porcine Sources: Bioprocessing Approaches and Challenges

by Darcy Birse, PhD, Dan Lacroix, PhD, Michael Dyck, PhD, François Pothier, PhD, and Marc-André Sirard, PhD, DMV
Volume 3, Issue 2 (March/April 2004)

The biopharmaceutical manufacturing sector is rapidly gearing up production capacity to satisfy the steadily escalating global demand for complex biologics to combat a number of treatable illnesses. Frequently, the biotherapeutics in demand are too complicated to be chemically synthesized and thus are beyond the reach of traditional pharmaceutical approaches. To effectively address this issue, these products must be developed and produced using viable and robust biological systems...

Birse D, Lacroix D, Dyck M, Pothier F, Sirard M. Biotherapeutics from Transgenic Porcine Sources: Bioprocessing Approaches and Challenges. BioProcess J, 2004; 3(2): 37-44.

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