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The Case for Design-Build Cleanroom Facilities Delivery

by Scott E. Mackler
Volume 2, Issue 3 (May/June 2003)

In the past, most large construction projects used a system called design-bid-build. Now, pharmaceutical companies planning cleanrooms have begun using an improved system, design-build, which can save millions of dollars and cut months from construction schedules. Design-build also can provide better quality end results than design-bid-build...

Citation:
Mackler SE. The Case for Design-Build Cleanroom Facilities Delivery. BioProcess J, 2003; 2(3): 62-64.

 
Managing Raw Materials in a Contract Manufacturing Facility

by Tina Young and Robin Douglas
Volume 2, Issue 3 (May/June 2003)

Long-term growth of the biopharmaceutical industry is increasingly relying on outsourcing to overcome the current capacity constraints, especially for monoclonal antibody production. Companies are often reluctant to commit to building multimillion dollar manufacturing facilities for potential products with no guarantee of approval. Therefore to offset risks, companies will enter into contract manufacturing arrangements...

Citation:
Young T, Douglas R. Managing Raw Materials in a Contract Manufacturing Facility. BioProcess J, 2003; 2(3): 47-49.

 
Biomarkers to Detect Molecular Changes in Tissue-Engineered Medical Products

by Henry Rodriguez, PhD, Catherine O'Connell, PhD, Peter E. Barker, PhD, Donald H. Atha, PhD, Pawel Jaruga, PhD, Mustafa Birincioglu, MD, Michael Marino, PhD, Patricia McAndrew, PhD, and Miral Dizdaroglu, PhD
Volume 2, Issue 3 (May/June 2003)

Tissue engineering is an emerging area of biotechnology that will provide replacement tissues for patients, as well as complex, functional biological systems for research and testing in the pharmaceutical industry. A new research area of tissue engineering is the investigation of how living cells interact with and respond to synthetic biomaterial surfaces. The clinical developments that underlie that research include a number of novel tissue-engineered medical products (TEMPs)...

Citation:
Rodriguez H, O'Connell C, Barker PE, Atha DH, Jaruga P, Birincioglu M, Marino M, McAndrew P, Dizdaroglu M. Biomarkers to Detect Molecular Changes in Tissue-Engineered Medical Products. BioProcess J, 2003; 2(3): 65-66.

 
Replacing Protein A Sorbents for the Large-Scale Manufacturing of Recombinant Antibodies: Hydrophobic Charge Induction Chromatography

by James Spencer, Egisto Boschetti, PhD, and Sylvio Bengio, PhD
Volume 2, Issue 3 (May/June 2003)

Monoclonal antibodies constitute a significant percentage of the protein-based therapeutic molecules currently in clinical trials. The broad applicability and proven commercial success for this class of molecules suggest a larger future market potential. The current biopharmaceutical manufacturing capacity is widely anticipated to be a rate-limiting factor in the growth of the biotech sector. Because antibody therapeutics represent such a large part of this market, and because the therapeutic dosages of antibodies tend to be greater than most biopharmaceuticals, there is an immediate need for novel antibody manufacturing approaches that deliver significantly greater productivity...

Citation:
Spencer J, Boschetti E, Bengio S. Replacing Protein A Sorbents for the Large-Scale Manufacturing of Recombinant Antibodies: Hydrophobic Charge Induction Chromatography. BioProcess J, 2003; 2(3): 67-72.

 
Monoclonal Antibody Products: Achievement and Prospects

by Anthony S. Lubiniecki, ScD
Volume 2, Issue 2 (March/April 2003)

Over 25 years have elapsed since Kohler and Milstein electrified the immunology community with their article describing the reliable preparation of monoclonal antibodies (MAbs) by fusing immune splencytes with immortalized myeloma cells. This discovery not only garnered the pair of scientists a Nobel Prize, but also led to the development of a technology which has yielded a number of important therapeutic, prophylactic, and diagnostic products for in vivo human use, and hundreds of in vitro diagnostic products. Some of these products proved to be significant in meeting previously unmet medical needs, and a few have been commercial successes. But the path, from Kohler and Milstein's discovery to commercial products, was discontinuous and a bit bumpy, and the technology continues to evolve...

Citation:
Lubiniecki AS. Monoclonal Antibody Products: Achievement and Prospects. BioProcess J, 2003; 2(2): 21-25. http://dx.doi.org/10.12665/J22.Lubiniecki.

 
Reagents for Assessing Seroreactivity Against Porcine Endogenous Retrovirus: Summary from Public Meeting and Workshop

by Carolyn A. Wilson, PhD, Eda T. Bloom, PhD, Louisa E. Chapman, MD, and Clive Patience, PhD
Volume 2, Issue 2 (March/April 2003)

Xenotransplantation has been defined by the US Public Health Service (PHS) as any procedure that involves the transplantation, implantation, or infusion into a human recipient of either (a) live cells, tissues, or organs from a nonhuman animal source, or (b) human body fluids, cells, tissues, or organs that have had ex vivo contact with live, nonhuman animal cells, tissues, or organs (PHS Guideline on Infectious Disease Issues in Xenotransplantation). In the US, several xenotransplantation clinical trials are in progress under US Food and Drug Administration (FDA) oversight. The PHS and the FDA have issued guidelines and guidance documents to address the potential for cross-species infection posed by the use of xenotransplantation products in humans. To minimize the infectious disease risk, these documents provide recommendations on how to screen and maintain source herds, individual source animals, and when possible, xenotransplantation products themselves. However, while precautions can be put in place to remove exogenous infectious agents, the endogenous retroviruses that a source species may carry cannot be removed...

Citation:
Wilson CA, Bloom ET, Chapman LE, Patience C. Reagents for Assessing Seroreactivity Against Porcine Endogenous Retrovirus: Summary from Public Meeting and Workshop. BioProcess J, 2003; 2(2): 27-30. http://dx.doi.org/10.12665/J22.Wilson.

 
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