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1. Cell Culture Engineering VI

Author

Michael J. Betenbaugh, Jeffrey J. Chalmers, Rob Arathoon, Frank W.R. Chaplen, Alison J. Mastrangelo, Michael J. Betenbaugh, Jeffrey J. Chalmers, Rob Arathoon, Frank W.R. Chaplen, and Alison J. Mastrangelo

Subjects
Biotechnology, Chemistry, Technical, Anatomy, Comparative, Biochemistry, Physical chemistry
Abstract

The latest edition in this continuing series includes the newest advances in the rapidly evolving field of animal cell culture, genetic manipulations for heterologous gene expression, cell line enhancements, improved bioreactor designs and separations, gene therapy manufacturing, tissue engineering, anti-apoptosis strategies and cell cycle research. The contents include new research articles as well as critical reviews on emerging topics such as viral and viral-like agent contamination of animal cell culture components. These papers were carefully selected from contributions by leading academic and industrial experts in the biotechnology community at the recent Cell Culture Engineering VI Meeting in San Diego, USA, 1998. However, the book is not merely a proceedings. Audience: Biochemical engineers, cell biologists, biochemists, molecular biologists, immunologists and other disciplines related to cell culture engineering, working in the academic environment and the biotechnology or pharmaceutical industry.

Published
2012

2. Recombinant Protein Expression Plasmids Optimized for Industrial E. coli Fermentation and Plant Systems Produce Biologically Active Human Insulin-like Growth Factor-1 in Transgenic Rice and Tobacco Plants.

Author

Mitra Panahi, Zaman Alli, Xiongying Cheng, Loubaba Belbaraka, and Jaafar Belgoudi

Abstract

Human insulin-like growth factor-1 (hIGF-1) is a growth factor with clinical significance in medicine. The therapeutic potential of recombinant hIGF-1 (rthIGF-1) stems from the fact that hIGF-1 resembles insulin in many aspects of physiology. The expression of hIGF-1 in transgenic tobacco and rice plants using different expression cassettes is reported here. In the present study, two coding sequences were tested, one with the original human sequence, but partially optimized for expression in E. coli and the other with a plant-codon-optimized sequence that was expected to give a higher level of expression in plant systems. Three different hIGF-1 recombinant expression constructs were generated. All expression constructs utilized the maize ubiquitin 1 promoter with or without a signal sequence. Analyses conducted using a hIGF-1 specific ELISA kit showed all transgenic plants produced hIGF-1 and the accumulated hIGF-1 increased from the E. coli codon bias to higher levels when the hIGF-1 coding sequence was codon-optimized to match that of the maize zeamatin protein – the most transcribed gene in maize endosperm suspension cells. Further analyses that compared the functionality of the bacterial signal peptide Lam B in plants showed that this leader peptide led to lower expression levels when compared to transgenic plants that did not contain this sequence. This indicated that this expression construct was functional without removal of the bacterial signal sequence. The maize ubiquitin 1 promoter was found to be more active in rice plants than tobacco plants indicating that in this case, there was a class preference that was biased towards a monocot host. Biological analyses conducted using protein extracts from transgenic plants showed that the rthIGF-1 was effective in stimulating the in vitro growth and proliferation of human SH-SY5Y neuroblastoma cells. This indicated that the plant-produced rthIGF-1 was stable and biologically active. As some plants have been reported to express an endogenous insulin-like protein, we also looked for any effect of the human growth factor in transgenic plants, but no developmental or morphological differences with wild type tobacco or rice plants were detected. Since insulin and hIGF-1 share some overlapping roles, hIGF-1 may become a substitute therapeutic agent in subjects with certain defects in their insulin receptor signaling. Hence, if the full beneficial potential of rthIGF-1 is achieved, it is expected that in the future the demand will likely increase significantly. [ABSTRACT FROM AUTHOR]

Published
2004

3. Handbook of Validation in Pharmaceutical Processes, Fourth Edition

Author

James Agalloco, Phil DeSantis, Anthony Grilli, Anthony Pavell, James Agalloco, Phil DeSantis, Anthony Grilli, and Anthony Pavell

Subjects
Pharmaceutical technology--Quality control, Sterilization, Pharmaceutical technology--Standards
Abstract

Revised to reflect significant advances in pharmaceutical production and regulatory expectations, Handbook of Validation in Pharmaceutical Processes, Fourth Edition examines and blueprints every step of the validation process needed to remain compliant and competitive. This book blends the use of theoretical knowledge with recent technological advancements to achieve applied practical solutions. As the industry's leading source for validation of sterile pharmaceutical processes for more than 10 years, this greatly expanded work is a comprehensive analysis of all the fundamental elements of pharmaceutical and bio-pharmaceutical production processes. Handbook of Validation in Pharmaceutical Processes, Fourth Edition is essential for all global health care manufacturers and pharmaceutical industry professionals.Key Features: Provides an in-depth discussion of recent advances in sterilization Identifies obstacles that may be encountered at any stage of the validation program, and suggests the newest and most advanced solutions Explores distinctive and specific process steps, and identifies critical process control points to reach acceptable results New chapters include disposable systems, combination products, nano-technology, rapid microbial methods, contamination control in non-sterile products, liquid chemical sterilization, and medical device manufacture

Published
2022

4. Validation of Pharmaceutical Processes

Author

James P. Agalloco, Frederick J. Carleton, James P. Agalloco, and Frederick J. Carleton

Subjects
Pharmaceutical technology, Quality control, Pharmaceutical technology--Standards, Sterilization, Pharmaceutical technology--Quality control
Abstract

Completely revised and updated to reflect the significant advances in pharmaceutical production and regulatory expectations, this third edition of Validation of Pharmaceutical Processes examines and blueprints every step of the validation process needed to remain compliant and competitive. The many chapters added to the prior compilation examine va

Published
2008

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