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The Intraocular Delivery of Neuroprotective Factors to the Retina Using Encapsulated Cell Technology

by Cahil McGovern, PhD, Sandy Sherman, Sue Mateus, William Tente, Mary Jane Dold, Anne Marie Bishop, and Weng Tao, MD, PhD
Volume 3, Issue 6 (November/December 2004)

Ophthalmic disorders are a group of diseases with a rapidly increasing frequency associated with an increase in the aged population. Patients with potentially blinding diseases have become one of the largest segments of the healthcare field, with more than 50 million patients in the United States alone. Their sight is threatened by diseases such as age-related macular degeneration (AMD), diabetic retinopathy (DR), glaucoma, or retinitis pigmentosa (RP). Until recently, there were essentially no effective treatment options to halt the progression of chronic, potentially blinding diseases. Biotechnological advances have resulted in the development of a variety of promising new protein factors that, if delivered to diseased cells of the retina, hold promise for treatment by interrupting or reversing the disease process...

Citation:
McGovern C, Sherman S, Mateus S, Tente W, Dold MJ, Bishop AM, Tao W. The Intraocular Delivery of Neuroprotective Factors to the Retina Using Encapsulated Cell Technology.
BioProcess J, 2004; 3(6): 35-41.

 
The Art of Raw Materials and Supplier Qualification

by Paula J. Shadle, PhD
Volume 3, Issue 6 (November/December 2004)

Rregulations and common sense require that a manufacturer qualify both the raw materials and the suppliers the firm will use to produce GMP supplies of a pharmaceutical or biopharmaceutical. Because the firm is accepting legal liability for the quality of all raw materials, it makes good business sense to devote resources to these activities. This article explores how to assure that qualification is complete, efficient, and compliant with current good manufacturing practice (cGMP), and discusses the challenges faced by today's manufacturers...

Citation:
Shadle PJ. The Art of Raw Materials and Supplier Qualification.
BioProcess J, 2004; 3(6): 43-46.

 
A Scalable Cell-Loading System for Non-Viral Gene Delivery and Other Applications

by Joseph C. Fratantoni, MD, Sergey Dzekunov, PhD, Sarah Wang, and Linda N. Liu, PhD
Volume 3, Issue 6 (November/December 2004)

Across many areas of biopharmaceutical development, the goal of consistently transfecting appropriate quantities of DNA into cells has often been a significant bottleneck. Electroporation — a method of temporarily permeabilizing cell membranes by using a short electric pulse — has gained ground in recent years as an effective means of transfection. A cell loading system based on electroporation has been designed for ex vivo cell modification in a clinical setting and for incorporation into cGMP processing applications...

Citation:
Fratantoni JC, Dzekunov S, Wang S, Liu LN. A Scalable Cell-Loading System for Non-Viral Gene Delivery and Other Applications.
BioProcess J, 2004; 3(6): 49-53.

 
Optimizing Protein Expression: Producing Pure Protein for Structural Biology

by Richard Wales
Volume 3, Issue 6 (November/December 2004)

Proteins and their promise for revolutionizing drug discovery have come virtually full circle in just a few decades. The advent of genetic engineering and the emergence of early recombinant proteins such as insulin and interferon dramatically boosted the perceived value of proteins in pharmaceutical research and of protein drugs in particular. Although the lights dimmed somewhat on the prpromise of therapeutic proteins in subsequent years, more recent times have seen a resurgence of interest in proteins, particularly monoclonal antibodies. Perhaps most telling has been the dawn of the post-genomic era, which has cast a bright spotlight on proteins, long respected as the work-horses of the cell, for their usefulness in exploring cell function, unraveling biochemical pathways, understanding disease, and for their massive value as novel drug targets...

Citation:
Wales R. Optimizing Protein Expression: Producing Pure Protein for Structural Biology.
BioProcess J, 2004; 3(6): 55-58.

 
Biogenerics in Developing Countries: Biotech Boom or Misguided Development Model?

by Keith L. Carson
Volume 3, Issue 5 (September/October 2004)

Several developing countries, including India and China, have young biopharmaceutical industries that have based much of their growth potential on the production of what are currently known as "biogeneric" products, or "bioequivalent" versions of biologics that have already been licensed in Western countries. With a disdain for foreign patents, an established philosophy of copying Western innovations, and success in generic pharmaceutical manufacturing, this approach appeared to be the logical way to build a biologic manufacturing industry. However, there are numerous problems with this development strategy. First and foremost is the inherent incompatability of the very concepts associated with biogeneric products...

Citation:
Carson KL. Biogenerics in Developing Countries: Biotech Boom or Misguided Development Model?
BioProcess J, 2004; 3(5): 27-29.

 
Intellectual Property "Must Dos" For Technology Companies

by David L. Parker, PhD, JD
Volume 3, Issue 5 (September/October 2004)

From an intellectual property (IP) standpoint, probably the two biggest problems I encounter in my practice for early-to-middle stage technology companies are: (1) their failure to fully understand and keep abreast of the competitive intellectual property environment , and (2) their failure to institute procedures that will permit and encourage development of a strategic intellectual property portfolio. By "strategic," I mean an intellectual property portfolio that focuses on both an offensive and defensive position — a portfolio that not only covers the product and all aspects of its manufacture, production, and applications (defensive portfolio development), but also provides significant blocking positions with respect to competitors' efforts...

Citation:
Parker DL. Intellectual Property "Must Dos" For Technology Companies.
BioProcess J, 2004; 3(5): 31-34.

 
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