Scale Up & Tech Transfer

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.
Aug 01, 2003
BioPharm International
Although gene therapy and DNA vaccination suggest promising new approaches to disease treatment - and nonviral vectors (which are cheap and easy to manufacture) afford low immunogenicity, better safety profiles, and improved stability - commercial-scale purification of plasmid DNA remains difficult, particularly if bovine-derived ribonuclease A is left out of the process. This article series reviews the benefits and limitations of current plasmid DNA purification and suggests an RNase-free downstream process that is scalable, robust, and meets the requirements set by industry regulators.
Jul 15, 2003
BioPharm International
By BioPharm International Editors
For maximum efficiency, high product yield, and purity, you must produce a homogeneous packed bed every time you perform a separation. Irregularities in packing cause uneven flow within the bed, resulting in band broadening, zone mixing, changes in flow rate, and subsequent loss of product yield and quality. Here we provide guidelines for reproducible column packing along with useful troubleshooting tips.
Jan 15, 2003
BioPharm International
By BioPharm International Editors
Anurag Rathore, Pharmacia Corporation and Ajoy Velayudhan
Optimizing your purification and separation process when your complex biological feedstock is ready for scale-up can be daunting. Your design process can be streamlined, simplified, and made cost efficient if you supplement your empirical approach with the theoretical and experimental tools presented in this article.
Jul 15, 2002
BioPharm International
By BioPharm International Editors
by Timothy N. Breece, Ellen Gilkerson, and Charles Schmelzer, Genentech, Inc.

May 15, 2002
BioPharm International
By BioPharm International Editors
by Timothy N. Breece, and Charles Schmelzer, Genentech, Inc.

FDA requires chromatography procedures to be validated for reuse, cleanability, sanitization, robustness, and (potentially) for virus removal. This case study follows the development of a validation process that combines reuse and characterization studies, defines acceptable running parameters, reduces costs, and meets GMP requirements.
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