Manufacturing Systems, Single-Use

Nov 02, 2007
BioPharm International
Disposables are increasingly being used in the manufacture of biopharmaceuticals. This article describes the design of a fully disposable process for the cGMP manufacture of clinical trial grade plasmid DNA. It addresses the rationale for implementing such a process with respect to the manufacture of patient-specific plasmid DNA vaccines for the treatment of leukemia. The process incorporates a number of disposable technologies, which are simple to use and thus reduce the need for investment in expensive equipment and cleaning validation.
Nov 02, 2007
BioPharm International
One of the challenges of adopting single-use technology is that not all cell lines are compatible with disposable bioreactors.
Nov 02, 2007
BioPharm International
A solution for the problems of a "bag in a can" system would be a fully jacketed and insulated container, similar to a traditional freeze tank.
Sep 13, 2007
BioPharm International
By BioPharm International Editors
The BIOSTAT Cultibag RM is a disposable bioreactor that combines rocking motion mixing technology with Sartorius engineered control capabilities.
Aug 02, 2007
BioPharm International
By BioPharm International Editors
Vaccines against strains originating from avian flu may achieve poor yields in egg-based systems. Consequently, both public and private interest in alternative systems is high.
Aug 02, 2007
BioPharm International
By BioPharm International Editors
The recent growth in the vaccine market has led to renewed interest in using adherent human cell lines for vaccine production. Traditionally, small-scale adherent cell line production has been carried out in roller bottles or T-flasks. Over the past few years, however, a number of companies have found multi-tray disposable bioreactors an effective method for producing high-quality drug products using adherent cells. These disposable, expandable systems have also facilitated scale up from laboratory to clinical-scale.
Aug 02, 2007
BioPharm International
By BioPharm International Editors
For pandemic vaccine processing, single-use filter cartridges and membrane chromatography technologies could offer significant time- and cost-reduction advantages.
Jun 21, 2007
BioPharm International
By BioPharm International Editors
The BioWelder and BioSealer from Sartorius (www.sartorius.com) are suitable for connecting or disconnecting thermoplastic tubing in biopharmaceutical manufacturing processes.
Jun 01, 2007
BioPharm International
By BioPharm International Editors
Today, most disposables are used for process development and clinical-scale manufacturing. Substantial growth in disposables usage may not occur until disposables are incorporated into the production of licensed products at commercial scale.
May 23, 2007
BioPharm International
By BioPharm International Editors
Millipore Corporation's disposable mixer is designed to help companies mix pharmaceutical ingredients and prepare cell culture media.
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