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An Alternative Method for the Rapid Generation of Stable, High-Expressing Mammalian Cell Lines

by Gregory T. Bleck, PhD
Volume 5, Issue 4 (Winter 2006)

Biopharmaceutical companies are constantly evaluating new methods for mammalian cell line development that provide benefits such as shorter timelines, improved consistency, higher production, better genetic stability, and increased flexibility. Each of these advantages extends a large cost benefit to companies as their recombinant protein products are moved from development into the clinic and finally to commercial launch. A versatile system has been developed that is capable of transferring genes of interest into a wide variety of mammalian host cells and offers a number of the above advantages over other methods. The system, which is referred to as GPEx™ (an acronym for “gene product expression”), utilizes replication-defective retroviral vectors, derived from Moloney murine leukemia virus (MLV) and pseudotyped with vesicular stomatitis virus G protein (VSV-G), to stably insert single copies of genes into dividing cells…

Bleck GT. An Alternative Method for the Rapid Generation of Stable, High-Expressing Mammalian Cell Lines.
BioProcess J, 2006; 5(4): 36-42.

Approach to the Pre-Clinical Evaluation of Agents for Anti-Psoriatic Activity

by James Varani, PhD
Volume 5, Issue 4 (Winter 2006)

Psoriasis is a chronic, inflammatory disease of the skin that is estimated to affect 2-3% of the U.S. population. The estimated annual outlay for treating the disease has ranged from $1.6 billion to $3.2 billion, and the cost to individuals with the disease is far higher than the monetary costs. Psoriasis is characterized by excessive keratinocyte proliferation, leading to a significant thickening of the epidermis, expansion of epidermal rete pegs into papillary dermal space and abnormalities in the differentiation process. Clinically, one sees red, raised, scaly lesions that can occur over any part of the body. The etiology of the disease is complex and not well understood. T-cells are almost certainly involved in the initiation and maintenance of psoriatic lesions. Although the triggering event is immunological, alterations in keratinocyte function also appear to be important to the overall pathophysiology…

Varani J. Approach to the Pre-Clinical Evaluation of Agents for Anti-Psoriatic Activity.
BioProcess J, 2006; 5(4): 44-49.

The Scaling of Process Filters By Flow Decay Studies

by Maik W. Jornitz and Theodore H. Meltzer
Volume 5, Issue 4 (Winter 2006)

The aim in process filtrations is to purify the liquid preparation by removing particulate impurities while obtaining as large a throughput as possible under practical conditions. The rate of flow should be expeditious enough to meet time constraints when necessary. This places a focus on the applied differential pressure level that motivates the liquid flow. A balance must be sought. Higher differential pressures increase the flow rates but may decrease throughputs by compaction of the filter cake. Also, higher applied pressures may minimize the adsorptive retention of particles. Deciding which is the proper filter involves small-scale filtration trials. The choice of the filter having been made, its size, in terms of the area necessary for the processing of the production batch, is arrived at by extrapolations from the small-scale tests that were performed…

Jornitz MW, Meltzer TH. The Scaling of Process Filters By Flow Decay Studies.
BioProcess J, 2006; 5(4): 53-56.

Planning for Your Cold Chain Shipment: The Forgotten Science of Clinical Research and Development

by Dan Catizone
Volume 5, Issue 4 (Winter 2006)

Many precautions are taken in a typical research lab to ensure the integrity of biological specimens. Temperature, storage, and personnel access, among others, are all tightly controlled, and codified into standard operating procedures (SOPs), if not almost biblical law. And no wonder — companies have millions invested in biotech solutions whose progress is often measured in years and decades. Scientists have their life’s work on the line. So, it is with some surprise that the diligence most companies exercise during the research and development process is not always maintained during specimen transport. Every time a specimen leaves the lab, be it for further analytical testing or investigational purposes, it runs a heightened risk of contamination, especially from fluctuating temperatures. Ensuring that this does not happen should be the responsibility and concern of everyone with a stake in a biological product’s success…

Catizone D. Planning for Your Cold Chain Shipment: The Forgotten Science of Clinical Research and Development.
BioProcess J, 2006; 5(4): 50-52.

Development and Manufacture of Alphavaccines

by Todd Talarico, PhD, Maureen Maughan, PhD, Bruno Pancorbo, Jennifer Ruiz, PhD, and Andrew Graham
Volume 5, Issue 3 (Fall 2006)

Vaccines represent the most effective means of disease prevention. A variety of vaccines including live-attenuated strains, inactivated organisms, and subunit forms are currently in use. However, advances in molecular biology, virology and immunology have made new classes of potential vaccines possible. One such class currently being developed by AlphaVax is based on an alphavirus-derived expression system. Alphaviruses are members of the Togaviridae family and have positive-sense RNA genomes. The RNA genome is surrounded by a capsid composed of 240 copies of a single capsid protein. Alphaviruses are enveloped viruses that mature at the plasma membrane of the host cell and are 50-70 nm in diameter. The viral envelope contains 80 trimers composed of two viral glycoproteins, E1 and E2. These trimers contain three E1-E2 heterodimers and are arranged in the viral envelope as spikes which protrude from the surface of the virus particle…

Talarico T, Maughan M, Pancorbo B, Ruiz J, Graham A. Development and Manufacture of Alphavaccines.
BioProcess J, 2006; 5(3): 8-14.

Conquering Design Challenges in the Construction of Immunomedics’ Multiproduct Cell Culture Bioreactor Facility

by Jeng-Dar Yang, PhD, Carl Sharo, Grant Merrill, and Cynthia Sullivan
Volume 5, Issue 3 (Fall 2006)

In the last few years, we have seen many biotech products approved by FDA. These products have gained public awareness because of their ability to treat several debilitating diseases with very minimal side effects, and thereby impact the quality of life for many people. As a result, the biotech industry is constantly in the news for its successes and programs to develop new therapeutics for many unmet medical needs. Immunomedics, Inc., a New Jersey biotechnology company, recently completed an expansion project that included new bioreactor manufacturing suites and support laboratories. Building on the company’s existing headquarters site and fully integrating the new capacity into the existing operational facility, the project spanned two years and was completed in 2003…

Yang J, Sharo C, Merrill G, Sullivan C. Conquering Design Challenges in the Construction of Immunomedics’ Multiproduct Cell Culture Bioreactor Facility. B
ioProcess J, 2006; 5(3): 15-23.

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