Scale Up

Mar 01, 2006
BioPharm International
Extra column effects must be accounted for to make a valid comparison
Feb 09, 2006
BioPharm International
Over the last three decades, numerous protein expression systems have been developed with various quality requirements on large and small scales. Huge steps have been made in large-scale protein production in mammalian systems while the small-scale mammalian systems are expensive and inflexible. Thus, small-scale production is done in simpler expression systems, sometimes sacrificing the quality of the proteins. However, relief is on the way.
Dec 01, 2005
BioPharm International
By BioPharm International Editors
The cell density achieved in a CELLine bioreactor is typically 1 to 2 orders of magnitude higher than in a conventional culture vessel
Jul 01, 2005
BioPharm International
By BioPharm International Editors
Cell-line and process development expertise, along with disposable systems, assist in implementing strategies for fast expression enhancements.
Apr 01, 2005
BioPharm International
By BioPharm International Editors
Creation and qualification of scale-down models is essential for performing several critical activities that support process validation and commercial manufacturing. This combined article is the fifth in the "Elements of Biopharmaceutical Production" series. Part 1 (March 2005) covered fermentation. In this segment, we present some guidelines and examples for scale-down of common downstream unit operations used in biotech processes — chromatography and filtration.
Mar 01, 2005
BioPharm International
By BioPharm International Editors
Lot-to-lot variations between raw materials can greatly impact process performance.
Jan 01, 2005
BioPharm International
In order to institute a GxP mindset across the organization, support and respect for quality systems should come from the top down.
Sep 01, 2004
BioPharm International
By BioPharm International Editors
Filtration is one of the most commonly used unit operations in the manufacturing of biopharmaceuticals. This is the second part of the fourth article in the "Elements of Biopharmaceutical Production" series. In this second segment, Manoj Menon and Frank Riske present an approach for the development and optimization of a TFF application, followed by a contribution from Jennifer Campbell and Elizabeth Goodrich reviewing key issues involved in validation of a TFF step.
Aug 01, 2004
BioPharm International
Filtration is one of the most commonly used unit operations in biopharmaceutical manufacturing. Available formats include direct or normal flow filtration (NFF) and cross or tangential flow filtration (TFF). These methods are used for sterilization and virus filtration, depth filtration or ultrafiltration, and diafiltration applications. Some common objectives include:
Sep 01, 2003
BioPharm International
The medical benefits of transgenes - effective against diseases such as cancer, HIV, malaria, and tuberculosis - require either a viral or nonviral vector. Nonviral vectors have lower immunogenicity, better safety profiles, and improved stability, as well as being less expensive and easier to produce. The first article in this series reviewed techniques suitable for the purification of plasmid DNA in the absence of added RNase. This article investigates a downstream process capable of producing gram quantities of pure plasmid DNA.
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