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Evaluation of In Vitro Methods for Monoclonal Antibody Production

by Jun T. Park, PhD, Cheng J. Cao, PhD, Sarah J. Cork, Kevin P. O'Connell, PhD, Darrel E. Menking, Tracy Coliano, and James J. Valdes, PhD
Volume 2, Issue 4 (July/August 2003)

Foreign substances, such as disease-causing viruses and other infectious agents are recognized by the body's immune system as invaders. Parts of the spectrum of our defenses are antibodies that bind these antigens and direct their destruction by other elements of the immune system. Antibodies have two very useful characteristics. First, they are extremely specific; that is, each antibody binds to one particular antigen. Second, the body retains the memory of encounters with antigens, enabling it to reproduce an antibody response to a later attack by that that same agent or disease. These properties make it possible to develop vaccines. It is the first trait of antibodies, their specificity, which makes monoclonal antibody (MAb) technology so valuable. Not only can antibodies be used therapeutically, to protect against disease, they also can help diagnose a wide variety of illnesses and can detect the presence of infectious agents (including biological threat agent). The use of MAbs specific for biological warfare agents in fielded assays requires maintaining a high-quality and economical supply of these reagents...

Park JT, Cao CJ, Cork SJ, O'Connell KP, Menking DE, Coliano T, Valdes JJ. Evaluation of In Vitro Methods for Monoclonal Antibody Production.
BioProcess J, 2003; 2(4): 49-56.

Mammalian Cell Culture: A Quality Approach

by Scott T. Waniger and Mark D. Hirschel, PhD
Volume 2, Issue 4 (July/August 2003)

Cell culture was first devised at the beginning of the 20th century as a method for studying the behavior of animal cells free of systemic variations that might arise in the animal both during normal homeostasis and under the stress of an experiment. During the past thirty, thousands of academic and for-profit organizations have come to rely on cultivation of animal cells as the basic foundation to perform biomedical research and large-scale biomanufacturing. Their success is directly dependent upon the reproducible production of high quality cell culture products. The complexity of the mammalian cell, its growth and storage requirements, and the need to maintain pure and uncontaminated cultures is a constant challenge to those involved with in vitro cell culture...

Waniger ST, Hirschel MD. Mammalian Cell Culture: A Quality Approach.
BioProcess J, 2003; 2(4): 61-67.

Biopharmaceutical Contract Manufacturing at the Crossroads

by Roger Lias, PhD
Volume 2, Issue 3 (May/June 2003)

Contract manufacturing of recombinant protein drugs and vaccines, as well as other biopharmaceuticals, has been the focus of considerable interest during the past decade. Fueled by a strong clinical development pipeline, primary manufacturing of biopharmaceuticals on a contract basis has attracted multinational industrial concerns willing to invest on the promise of potentially higher returns than are experienced in the production of traditional small molecule drugs. Biopharmaceutical contract manufacturers have made significant contributions to the development and subsequent commercialization of a few highly successful products. However, despite strong growth, consistent profitability has been elusive. The market has changed overr the past decade as customer projects progressed from process development through market launch. Now that several preeminent market players have successfully made the difficult transition from clinical to commercial supplier, what has been learned and how is the market expected to evolve over the next five years?...

Lias R. Biopharmaceutical Contract Manufacturing at the Crossroads.
BioProcess J, 2003; 2(3): 19-23.

Bioreactor Process Selection for Large-Scale Manufacture of Monoclonal Antibodies — Tradeoffs and Recommendations

by Mina D. Mahadevan, PhD
Volume 2, Issue 3 (May/June 2003)

Bioreactor productivities are highly dependent on the process used to cultivate mammalian cells. These productivities directly affect the manufacturing plant capacity, and thereby the economics of production of monoclonal antibodies (MAbs). Historically, companies have chosen bioreactor process strategies that emphasize simplicity of scale-up at the expense of productivity, and conducted manufacturing using well-characterized and relatively straightforward batch processes. Such processes have successfully produced small or moderate quantities (ranging from ~100 g to ~ 1 kg per lot) of the desired antibody. Given the anticipated demand for large-scale quantities of MAbs (and the high stakes for the companies investing in these new biological entities), it is worthwhile to revisit these past selection strategies and see if — and under what conditions — they remain optimal today...

Mahadevan MD. Bioreactor Process Selection for Large-Scale Manufacture of Monoclonal Antibodies — Tradeoffs and Recommendations.
BioProcess J, 2003; 2(3): 25-31.

Biopharmaceutical Contract Manufacturing: An Overview

by David Sherwood, PhD
Volume 2, Issue 3 (May/June 2003)

The revolution in biotechnology has led to 133 biotechnology-derived medicines being approved by 2001 with sales of $22 billion. This is less than 10 percent of today's total pharmaceutical market, but it is a rapidly growing sector. Biologics are predicted to grow to nearly $50 billion by 2008. Marketed biopharmaceuticals include several blockbuster products with multibillion-dollar sales. In recent years, biotechnology-derived therapies represented 10 percent to 20 percent of all new approved molecular entities and hundreds more are in development, including nearly 200 proteins in late-stage trials. Microbial and mammalian expression systems are typically used to produce biotherapeutic proteins (many companies are also working on transgenic expression systems). Microbial cultures (typically, Escherichia coli or yeast) are used to produce smaller, less-complex proteins or those where specific modifications, especially glycosolation, are not required...

Sherwood D. Biopharmaceutical Contract Manufacturing: An Overview.
BioProcess J, 2003; 2(3): 33-35.

Structure Characterization of a Recombinant Monoclonal Antibody with One- and Two- Dimensional High Performance Liquid Chromatography with On-line Electrospray Ionization Mass Spectrometry

by Brooks R. Sunday
Volume 2, Issue 3 (May/June 2003)

Recombinant monoclonal antibodies (rMAbs) are the predominant biotherapeutic protein under development today. FDA requires the structure characterization if rMAbs and other recombinant proteins to grant marketing approval. Characterizing such complex, inherently heterogeneous molecules is a significant analytical challenge that requires a broad array of physico-chemical tests. This article reports the use of reversed phase high-performance liquid chromatography (RP-HPLC) with on-line electrospray ionization mass spectrometry (ESI-MS) to rapidly determine the glycoform composition and the heavy chain C-terminal lysine heterogeneity of an intact rMAb. In addition, a novel multidimensional chromatographic platform was developed to investigate the two-dimensional, size exclusion chromatography (HPSEC) separation of the rMAb followed by RP-HPLC (HPSEC-RP-HPLC) with on-line ESI-MS analysis. Such analyses can characterize, identify, and confirm the structure of an intact rMAb...

Sunday BR. Structure Characterization of a Recombinant Monoclonal Antibody with One- and Two- Dimensional High Performance Liquid Chromatography with On-line Electrospray Ionization Mass Spectrometry.
BioProcess J, 2003; 2(3): 37-45.

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