Pharmaceutical Technology, May 1, 2011 - Pharmaceutical Technology

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Pharmaceutical Technology, May 1, 2011
Bioprocessing Trends: Annual Survey
By Michelle Hoffman
Results from our annual survey. This article contains online bonus material and is part of a special issue on Bioprocessing and Sterile Manufacturing.
Industrializing Design, Development, and Manufacturing of Therapeutic Proteins
By Trevor J. Hallam , Christopher J. Murray
The authors discuss various approaches and related issues, including production of difficult-to express proteins using cell-free expression systems, scalability of protein expression, and site-specific chemical modifications.
Methods for the Automated Manufacturing of an Autologous Dendritic-Cell Immunotherapy
By Tamara T. Monesmith
The authors developed automated equipment that uses functionally closed disposables to perform cellular and ribonucleic processing.
Peptide PEGylation: The Next Generation
By Baosheng Liu
Linking peptides to polyethylene glycol, or PEGylation, has helped improve pharmaceutical therapeutics in several ways. A wave of new techniques is now ushering in further advances.
Perspectives in MicroRNA Therapeutics
By Kevin Steffy , Charles Allerson , Balkrishen Bhat
The authors provide further insight into microRNA biology, and the simplicity of anti-miR oligonucleotide drug delivery.
Technologies for Downstream Processing in Biologics
By Margrit Holzer
The author describes recent developments to help overcome the downstream processing bottleneck. This article is part of a special issue on Sterile Manufacturing and Bioprocessing.
The Future of Downstream Processing
By Uwe Gottschalk
The author reviews the state of downstream processing and considers potential solutions, including the streamlining of full processes and borrowed technologies.
Strategies in Parenteral Drug Manufacturing
A technical forum moderated by Patricia Van Arnum
Regulation of Aseptic Processing in the 21st Century
By James E. Akers , James P. Agalloco
The authors question certain aspects of the industry's current regulatory-compliance strategy and suggest that aseptic-process control and evaluation should be revised.


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FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
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Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
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