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Viral Gene Vectors

by Sybille L. Sauter
Volume 2, Issue 3 (May/June 2003)

An astonishing range of viruses has provided building blocks for gene delivery systems, from the simple adeno-associated virus with a 5 kb genome to the complex poxviruses with 300 kb. This review focuses on non-replicating viral vectors that infect host cells just once, without producing infections virus. Viral vectors are generally characterized by several criteria, including their ability to integrate into the host genome, coding capacity, titer, toxicity, immunogenicity, host range, duration of gene expression, and transient or stable production systems. These are precisely the features that need to be carefully studied in the context of the application when deciding which vector to use...

Citation:
Sauter SL. Viral Gene Vectors. BioProcess J, 2003; 2(3): 56-61.

 
Adenovirus Reference Materials: Determination of Particle Concentrations Obtained by Orthogonal, Physical-Chemical Methods

by Elisabeth Lehmberg, PhD, Paul Shabram, Thomas Schluep, ScD, Shu Fen Wen, PhD, Barry Sugarman, PhD, Maria Croyle, Michael Koehl, Edwige Bonfils, PhD, Daniel Malarme, Geoffrey Sharpe, PhD, Heike Nesbit, PhD, Flavia Borellini, PhD, Amine Kamen, PhD, Beth Hutchins, PhD, and Gary Vellekamp, PhD
Volume 2, Issue 3 (May/June 2003)

With the continued progress of adenoviral vectors in gene therapy studies it is increasingly evident that a more formalized approach to the characterization and analysis of these viral vectors is urgently needed. Today, adenoviral vectors are beginning to be considered "well characterized biologics," as shown by numerous publications describing sophisticated analytical approaches for recombinant adenovirus product candidates. Because the analytical definitions of adenoviral vectors currently lack comparison to a common standard, the problem for regulatory agencies is how to objectively evaluate safety in relation to the administered dose. This well-recognized need for an adenovirus standard has been addressed by a consortium of representatives from regulatory agencies, industry, and academic organizations — the Adenoviral Reference Material (ARM) Working Group. Its work has come to fruition in the recent public availability of the ARM, a purified wild type 5 adenovirus. Many aspects of the history, production, and characterization of the ARM have been published in detail...

Citation:
Lehmberg E, Shabram P, Schluep T, Wen SF, Sugarman B, Croyle M, Koehl M, Bonfils E, Malarme D, Sharpe G, Nesbit H, Borellini F, Kamen A, Hutchins B, Vellekamp G. Adenovirus Reference Materials: Determination of Particle Concentrations Obtained by Orthogonal, Physical-Chemical Methods. BioProcess J, 2003; 2(3): 50-55.

 
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.

 
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