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Gene Therapy with Viral Vectors

by Douglas J. Jolly, PhD
Volume 2, Issue 5 (September/October 2003)

The modern era of interest in gene transfer as a methodology for treating disease began around 1985 with the first use and publication of mouse-based retroviruses that could transduce human cells. In fact, the use of gene transfer as a clinically useful method is probably older than any other therapy commonly used today — it forms the basis for the vaccinia vaccination against smallpox, popularized in Western medicine by Jenner. Another antecedent is phage therapy for bacterial infection, which was largely but not completely superseded by antibiotics (although it may make a comeback in this era of drug-resistant pathogenic bacterial strains.) Other examples include the other live viral vaccines: measles/mumps/rubella, polio, varicella, tuberculosis, influenza, the use of bacillus Calmette-Guérin (BCG) as a therapeutic for bladder cancer bone marrow transplants, and even the use of maggots to clean wounds...

Citation:
Jolly DJ. Gene Therapy with Viral Vectors.
BioProcess J, 2003; 2(5): 19-25.

 
The Complete Nucleic Acid Sequence of the Adenovirus Type 5 Reference Material (ARM) Genome

by Barry J. Sugarman, PhD, Beth M. Hutchins, PhD, Diane L. McAllister, Fei Lu, MD, and Kenneth B. Thomas, PhD
Volume 2, Issue 5 (September/October 2003)

The Adenovirus Reference Material Working Group (ARMWG) oversaw development of an adenovirus reference material (ARM) with the intent to provide a way to standardize assay measurements from different laboratories. The ARM, which was manufactured in stages by various organizations including Canji (San Diego, CA) and Introgen Therapeutics (Houston, TX), is available from American Type Culture Collection (Manassas, VA). Upon completion of its manufacture, the characterization phase primarily defined viral particle concentration as well as infectious titer for this product. However, many other concurrent characterization studies were conducted including an assessment of vector purity (e.g., host cell DNA, host cell protein, reversed-phase HPLC), a short-term field use and shipping stability study, and a long-term stability study. Also included in these studies was a coordinated effort to determine the complete DNA sequence of the ARM vector genome...

Citation:
Sugarman BJ, Hutchins BM, McAllister DL, Lu F, Thomas KB. The Complete Nucleic Acid Sequence of the Adenovirus Type 5 Reference Material (ARM) Genome.
BioProcess J, 2003; 2(5): 27-33.

 
Role of the Container/Closure System and Formulation on Agitation-Induced Aggregation Phenomena in Recombinant Adenoviral Products

by Maria A. Croyle, PhD, Katie Gerding, and Kayla S. Quick, Pharm.D.
Volume 2, Issue 5 (September/October 2003)

The biologic activity of protein therapeutics is often compromised by the formation of soluble aggregates and protein precipitates. While the detailed molecular mechanism of protein aggregation remains unclear, substantial evidence suggests that factors that promote protein unfolding and exposure of hydrophobic residues play a significant role in aggregate formation. These can vary according to the particular protein of interest, the solvent system, and storage conditions. Slight changes in temperature, pH, and ionic strength have been documented to have a significant effect on the aggregation phenomena of numerous proteins. Freezing and subsequent thawing of a preparation (whether by design or accident) during processing, shipping, and storage can induce subtle changes in the ionic strength, solute concentration, and pH of a given preparation and induce aggregate formation...

Citation:
Croyle MA, Gerding K, Quick KS. Role of the Container/Closure System and Formulation on Agitation-Induced Aggregation Phenomena in Recombinant Adenoviral Products.
BioProcess J, 2003; 2(5): 35-41.

 
A Rational Approach to Monoclonal Antibody Development According to Predefined Assay Criteria

by Richard T. Root
Volume 2, Issue 5 (September/October 2003)

Monoclonal antibodies (MAbs) destined for use in drug-specific assays must meet specific binding criteria, and therefore require much more in the way of development than many protein-specific antibodies. This article describes one way to facilitate the development of well-characterized, high specificity MAbs. Essentially the same techniques have also been used for producing MAbs that are cancer markers and MAbs that are specific for infectious agents. Monoclonal antibody development, as in other endeavors, requires clearly defined goals and an examination of proposed methods to attain them. This has been succinctly stated by the phrase “Start with the end in mind.” Unfortunately, the vast majority of hybridoma development could be more appropriately described by Yogi Berra, “If you don’t know where you are going, you will wind up somewhere else.” In most laboratories, fusions are carried out with the goal of reducing the amount of cell culture and handling required and using the minimum amount of screening. Little or no consideration is given to ensuring that single clones are subjected to the screening tests. Under these conditions, it is little wonder that dozens of fusions can be carried out, each with the same result — no specific antibody found...

Citation:
Root RT. A Rational Approach to Monoclonal Antibody Development According to Predefined Assay Criteria.
BioProcess J, 2003; 2(5): 43-49.

 
The Study of GPCR Activity Using Insect Cell Membranes and AlphaKey Peptide Probes

by Margaret Dey, Kevin Ramer, PhD, Carmen Roques, Hanne Gron, PhD, Rainer Blaesius, PhD, Whitney Nicholson, and Zoey Fredericks, PhD
Volume 2, Issue 5 (September/October 2003)

G protein-coupled receptors (GPCRs) comprise a “superfamily” of cell surface receptors that play a prominent role in cell signalling and are classified into more than 100 subfamilies according to sequence, ligand structure, and receptor function. They are cell surface receptor proteins with seven transmembrane domains which transduce extracellular signals to the interior of cells through heterotrimeric G proteins. GPCRs’ exposure at the exterior cell surface and strong role in cell regulation has provided a rich target family for small compound therapeutics. Of the estimated 35,000 genes in the human genome, approximately 750 encode for GPCRs; half likely encoding sensory receptors, the remaining half representing potential drug targets. Only about 30 of these potential targets are currently modulated by existing pharmaceuticals with approximately 400 remaining potential pharmaceutical targets for validation...

Citation:
Dey M, Ramer K, Roques C, Gron H, Blaesius R, Nicholson W, Fredericks Z. The Study of GPCR Activity Using Insect Cell Membranes and AlphaKey Peptide Probes.
BioProcess J, 2003; 2(5): 51-55.

 
The Use of Experimental Design Methods in the Development of a High Concentration Lyophilized Formulation for a Humanized Monoclonal Antibody

by Supriya Gupta, PhD, Aleni-Flores Nate, and Elizabet Kaisheva, PhD
Volume 2, Issue 5 (September/October 2003)

An important aspect of developing protein therapeutics is identifying formulation components that stabilize the molecule in order to provide the desired product storage stability. Generally, an aqueous formulation is preferred; however, the instability of proteins, both physical (e.g. aggregation) and chemical (e.g. deamidation and oxidation), often necessitates the development of lyophilized formulations. In these formulations, selection of the appropriate stabilizing cryoprotectants, lyoprotectants, and bulking agents is critical. Accelerated stability studies are typically used to evaluate the effect of a single factor at a time in order to identify the optimum pH, buffer, and stabilizing excipients. This approach is limited in that many independent time-consuming experiments must be run, the results are obtained only at the evaluated set points, and additional experiments are required to assess potential interactions between the evaluated factors...

Citation:
Gupta S, Nate A, Kaisheva E. The Use of Experimental Design Methods in the Development of a High Concentration Lyophilized Formulation for a Humanized Monoclonal Antibody.
BioProcess J, 2003; 2(5): 57-63.

 
Production of a Recombinant Influenza Vaccine Using the Baculovirus Expression Vector System

by Kathleen M. Holtz, PhD, D. Karl Anderson, PhD, and Manon M.J. Cox
Volume 2, Issue 5 (September/October 2003)

Influenza is a highly contagious, acute viral respiratory disease that occurs seasonally in most parts of the world. The infection resides primarily in the respiratory tract (nose, throat and bronchi), but causes both local and systemic symptoms including fever, chills, cough, headache, myalgia, sore throat, and malaise. Influenza-related pneumonia is the main complication of infection. Annual epidemics cause significant morbidity and mortality worldwide. Each year, influenza infections result in an average of 110,000 hospitalizations, approximately 20,000 of which result in death. These deaths are heavily concentrated (>90%) among persons who are at highest risk for influenza-related complications — elderly adults (over 65), children under age five, patients with pre-existing respiratory or cardiovascular disease, and women in the third trimester of pregnancy. Thus, the prevention of influenza virus infection is a major public health priority...

Citation:
Holtz KM, Anderson DK, Cox MMJ. Production of a Recombinant Influenza Vaccine Using the Baculovirus Expression Vector System.
BioProcess J, 2003; 2(5): 65-73.

 
Advanced Methods of Adenovirus Vector Production for Human Gene Therapy: Roller Bottles, Microcarriers, and Hollow Fibers

by Tatyana Isayeva, MD, PhD, Olga Kotova, MD, Victor Krasnykh, PhD, and Alexander Kotov, MD, PhD
Volume 2, Issue 5 (September/October 2003)

Various types of viral vectors are being employed extensively as gene therapeutics to treat cancer and genetic diseases. Among the viruses that have been produced for human clinical trials (i.e. retrovirus, adenovirus, poxvirus, adeno-associated virus, and herpesvirus vectors) adenoviruses exhibit the lowest pathogenicity yet still infect an extensive range of cell types with high efficiency. These key characteristics make recombinant adenoviruses efficient gene-delivery vehicles and excellent research tools. However, the time-consuming and complex processes of generation, amplification, purification, and quality testing associated with production of recombinant adenoviruses make it difficult for many researchers to utilize these vectors. This is particularly true with respect to cell culture optimization and the virus propagation protocols employed in vector production. In this regard, the development of innovative cell culture techniques has become vital for optimizing vector production for gene therapy...

Citation:
Isayeva T, Kotova O, Krasnykh V, Kotov A. Advanced Methods of Adenovirus Vector Production for Human Gene Therapy: Roller Bottles, Microcarriers, and Hollow Fibers.
BioProcess J, 2003; 2(5): 75-81.

 
Defining a Detailed Approach to Using the Adenovirus Reference Material (ARM)

by Nancy Sajjadi and Janice Callahan, PhD
Volume 2, Issue 5 (September/October 2003)

Through the tremendous efforts of the Adenovirus Reference Material Working Group (ARMWG), an adenovirus reference material (ARM) is now available from the American Type Culture Collection (ATCC). The history and progress of the ARM production and characterization has been presented at many meetings and published in numerous journal articles. Although general statements have been made regarding how the ARM should be used, there is no formal directive or specific set of instructions detailing its application in the field. The goals of this paper are (1) to briefly review the objectives for development and implementation of the ARM, (2) to describe a critical assumption necessary to meet those objectives, (3) to outline specific approaches for using the ARM, and (4) to highlight the need for a working group to address the issues raised in the process...

Citation:
Sajjadi N, Callahan J. Defining a Detailed Approach to Using the Adenovirus Reference Material (ARM).
BioProcess J, 2003; 2(5): 83-87.

 
Large-scale Purification of a Lentiviral Vector by Size Exclusion Chromatography or Mustang Q Ion Exchange Capsule

by Vladimir Slepushkin, MD, PhD, Nancy Chang, Reuben Cohen, Yuxiang Gan, Bing Jiang, Eden Deausen, David Berlinger, Gwendolyn Binder, PhD, Kris Andre, Laurent Humeau, PhD, and Boro Dropulic, PhD
Volume 2, Issue 5 (September/October 2003)

The use of virus-based vectors for gene transfer has become an important delivery method for both in vitro applications and in vivo experimental clinical therapies. In small-scale experimental applications, most vectors can easily be concentrated and purified by simple methods (for example, ultracentrifugation.) However, it is challenging to scale up centrifugation-based vector purification methods for the large-scale production required for clinical use. In particular, when considering production of vector for human use, additional steps such as final sterilization by filtration must be taken to ensure the purity and safety of the vector preparation. Because the vector aggregates when pelleted by centrifugation, sterile filtration will eliminate vector particles from the solution. An efficient vector purification process that maintains vector potency is an important step in vector production for gene therapy...

Citation:
Slepushkin V, Chang N, Cohen R, Gan Y, Jiang B, Deausen E, Berlinger D, Binder G, Andre K, Humeau L, Dropulic B. Large-scale Purification of a Lentiviral Vector by Size Exclusion Chromatography or Mustang Q Ion Exchange Capsule.
BioProcess J, 2003; 2(5): 89-95.

 
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