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Rapid At-Line Antibody Titre Determination Using the MININEPH Endpoint Nephelometer

by Kym Baker, PhD, Leanna Jones, Alison Smith, PhD, Hilary Harrop, PhD, and Steve Flatman, PhD
Volume 5, Issue 2 (Summer 2006)

One of the major aims of modern biotechnology companies that are producing recombinant therapeutic proteins is to focus on timeline reduction of critical cell line selection and process optimisation studies in order to minimise the time and financial constraints of early development products. This “minimalist paradigm” of maximising early development throughput with minimal capital/operational outlays is a key driver for implementation of novel analytical technologies which can be applied atline to process instrumentation. The large-scale production of recombinant therapeutics in the biopharmaceutical industry relies on in-process monitoring of product titre. Traditional titre determination methods, including enzyme-linked immunosorbent assay (ELISA) and protein A high performance liquid (immunoaffinity) chromatography (Protein A HPLC), are time consuming, and often reliant on analytical support from separate specialist teams/departments requiring detailed scientific knowledge and extensive training, with expensive capital outlay utilising large equipment...

Citation:
Baker K, Jones L, Smith A, Harrop H, Flatman S. Rapid At-Line Antibody Titre Determination Using the MININEPH Endpoint Nephelometer.
BioProcess J, 2006; 5(2): 71-77. https://doi.org/10.12665/J52.Baker.

 
A Divergent View on the Significance of Tissue Culture — A Speculative Essay

by Gordon H. Sato, PhD
Volume 5, Issue 1 (Spring 2006)

The significance of tissue culture is that an understanding of animal physiology will come from a study of the basic elements of the animal (the cell) in isolated, pure form (clonal culture), under defined conditions (hormonally defined media). This should be the fundamental approach to animal physiology for the foreseeable future. The problem with this formulation in 1958, when I began work on tissue culture, was that cells in culture did not display the differentiated properties of the tissue of origin...

Citation:
Sato GH. A Divergent View on the Significance of Tissue Culture — A Speculative Essay.
BioProcess J, 2006; 5(1): 15-16. https://doi.org/10.12665/J51.Sato.

 
Protein Recovery from Tobacco Extract by Non-Chromatographic Methods

by Chenming (Mike) Zhang, PhD
Volume 5, Issue 1 (Spring 2006)

For more than a decade, transgenic plants have been investigated as alternatives to microbial, mammalian cell, and transgenic animal systems for recombinant protein production. The main advantages of using plants as "bioreactors" are that the cost of upstream production (i.e. biomass creation) is low; plants do not carry viruses and other pathogens dangerous to humans such as human immunodeficiency virus (HIV), prions, hepatitis viruses and so on; and as eukaryotes, plants are capable of producing bioactive proteins. Numerous recombinant proteins have been expressed in various plant hosts, and some recombinant proteins are in various stages of clinical trials...

Citation:
Zhang C. Protein Recovery from Tobacco Extract by Non-Chromatographic Methods.
BioProcess J, 2006; 5(1): 19-23. https://doi.org/10.12665/J51.Zhang.

 
Improved Expression of ADAM17 by Co-Expression of the Furin Convertase Protein Using Recombinant Baculoviruses

by Loĭc Glez, Christophe Losberger, and Thierry Battle, PhD
Volume 5, Issue 1 (Spring 2006)

The baculovirus expression vector system, which is based on infecting insect cells with recombinant Autographa californica nuclear polyhedrosis virus (AcNPV), is one of the most commonly used eukaryotic expression systems aimed at producing functionally active mammalian proteins. It offers advantages such as high-level protein expression and post-translational processing capabilities that are extremely important to the biological activity of certain proteins. This system utilizes a strong promoter of the very late gene, polyhedrin, to drive heterologous protein pverexpression. Nevertheless, in order to generate milligram amounts of recombinant proteins, cell culture often needs to be scaled up to as much as 25 liters....

Citation:
Glez L, Losberger C, Battle T. Improved Expression of ADAM17 by Co-Expression of the Furin Convertase Protein Using Recombinant Baculoviruses.
BioProcess J, 2006; 5(1): 24-28. https://doi.org/10.12665/J51.Glez.

 
The Quest for a Generic IgG Purification Process

by Pete Gagnon
Volume 5, Issue 1 (Spring 2006)

The outstanding success and safet record of first generation monoclonal products has created an immense increase in the number of product candidates that need to be evaluated clinically. The concept of platform purification has emerged in response to this need. A platform is a semigeneric, multistep purification procedure that can be applied to a wide range of monoclonal antibodies without extensive mehtod-scouting and optimization. This approach can substantially accelerate process development and hasten inception of clinical trials...

Citation:
Gagnon P. The Quest for a Generic IgG Purification Process.
BioProcess J, 2006; 5(1): 31-36. https://doi.org/10.12665/J51.Gagnon.

 
Development of a Production and Purification Method for Type 5 Adenovirus

by Scott Jendrek, Denise Ekstrom, PhD, Daniel Stoughton, PhD, Sawako Ishikawa, Dexter Poon, PhD, Wei Cheng, Steve Giardina, PhD, and David Mallard
Volume 5, Issue 1 (Spring 2006)

The number of viral vectors designed for gene therapy applications in the cGMP pipeline is staggering. Similar in scope to the flurry of recombinant protein products of the 1980s and the monoclonal antibodies (MAbs) of the 1990s, viral vector-based products are surging from research labs and universities into contract manufacturing organizations (CMOs), ultimately destined for use in clinical trials. Unlike recombinant proteins and MAbs, both of which sometimes require grams of vialed final product to start Phase I studies, the amount of material required to move a viral vector-based product into clinical trials can be minute in comparison. Of all the viral vectors currently in clinical trials, more than 25% are based on adenovirus...

Citation:
Jendrek S, Ekstrom D, Stoughton D, Ishikawa S, Poon D, Cheng W, Giardina S, Mallard D. Development of a Production and Purification Method for Type 5 Adenovirus.
BioProcess J, 2006; 5(1): 37-42. https://doi.org/10.12665/J51.Jendrek.

 
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