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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.

 
GMPs-Grade Retroviral Vector Manufacturing: Process and Facility Design

by Cecilia Sendresen, PhD
Volume 3, Issue 5 (September/October 2004)

The Good Manufacturing Practices (GMPs) are becoming more and more familiar in biotechnology, and concepts such as quality assurance or validation are now part of the background of clinicians and researchers involved in clinical trials. A recent European Community directive (2001/20/CE) states that GMPs should also be applied to investigational medicinal products and not only to products on the market. Vector supernatant is a so-called Active Pharmaceutical Ingredient (API) and is subject to the same guidelines as traditional drugs produced by the pharmaceutical industry. This has a deep impact in the field of gene therapy because clinical trials are often run by small biotech companies or, at least in the first phases, by academic centers. The field is continuously developing and, according to the progress of the clinical studies, new processes are necessary to produce large-scale amounts of vector supernatant in a safe and reproducible way...

Citation:
Sendresen C. GMPs-Grade Retroviral Vector Manufacturing: Process and Facility Design.
BioProcess J, 2004; 3(5): 37-39.

 
Use of a Fluidized-Bed Bioreactor for the Production of Retroviral Vectors for Gene Therapy Applications

by James N. Warnock, PhD, Toby Price, PhD, Andrew Slade, PhD, and Mohamed Al-Rubeai, PhD
Volume 3, Issue 5 (September/October 2004)

Gene therapy is a promising medical technology that has the ability to treat inherited diseases. However, efficient and economical large-scale production of vectors is necessary to meet the potential patient demand. Several approaches have been evaluated for the mass production of retroviral vectors, including fixed-bed bioreactors, suspension cultures, and microcarrier cultures. In this article, we report on the use of a Cytopilot fluidized-bed bioreactor for the production of retroviral vectors from the human packaging cell line TEFLYRD...

Citation:
Warnock JD, Price T, Slade A, Al-Rubeai M. Use of a Fluidized-Bed Bioreactor for the Production of Retroviral Vectors for Gene Therapy Applications.
BioProcess J, 2004; 3(5): 41-45.

 
Nucleic Acid Analysis of Viral Vectors: A Contract Research Organization's Perspective

by Kenneth R. Paynter, Hui Hou, and Fei Lu, MD
Volume 3, Issue 5 (September/October 2004)

Currently, the U.S. Food and Drug Administration (FDA) recommends DNA sequencing for the structural characterization of gene transfer viral vectors in investigational New Drug Applications (INDs). While FDA provides guidelines on what should be sequenced in regard to these vectors, it provides little insight — beyond GLP/GMP (GxP) guidelines — into how the finalized sequence data should be obtained. There is presently no provision for determining which sequencing methodology (or methodologies) is most appropriate for obtaining a completed sequence characterization for each of the different vector classes, and there is no standard that outlines what DNA sequencing-specific criteria the data and data collection processes should meet in order to guarantee that the sequence is 99.99% accurate...

Citation:
Paynter KR, Hou H, Lu F. Nucleic Acid Analysis of Viral Vectors: A Contract Research Organization's Perspective.
BioProcess J, 2004; 3(5): 47-51.

 
Application of Chemically-Stable Immunoglobulin-Selective Sorbents: Capture and Purification of Antibodies with Resolution of Aggregate

by Warren Schwartz, PhD, Jin-an Jiao, Jill Ford, Daniel Conrad, Jean-Francois Hamel, Patrick Santambien, Lisa Bradbury, and Thibault Robin
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:
Schwartz W, Jiao J, Ford J, Conrad D, Hamel J, Santambien P, Bradbury L, Robin T. Application of Chemically-Stable Immunoglobulin-Selective Sorbents: Capture and Purification of Antibodies with Resolution of Aggregate.
BioProcess J, 2004; 3(5): 53-62.

 
Ancillary Products for Cell and Gene Therapy and Tissue Engineering: USP Initiative

by Roger Dabbah, PhD
Volume 3, Issue 4 (July/August 2004)

The United States Pharmacopeia (USP) is a 184-year-old organization that has been in the forefront of technology since its inception. From publishing a manual about how to prepare therapeutic potions, USP has evolved into a compendium of standards and information on manufactured pharmaceutical products, with more than 4,000 monographs covering drug substances and biologics, and their dosage forms, excipients, and nutritional supplements. It is not surprising that the USP initiative in cell and gene therapy and tissue engineering has closely followed the emergence of these technologies...

Citation:
Dabbah R. Ancillary Products for Cell and Gene Therapy and Tissue Engineering: USP Initiative.
BioProcess J, 2004; 3(4): 21-22.

 
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