Scale Up

Sep 13, 2007
BioPharm International
By BioPharm International Editors
Small biotechnology companies often need guidance during the development of new therapies—particularly when it comes to manufacturing.
Sep 01, 2007
BioPharm International
By BioPharm International Editors
From the earliest days of the biotechnology industry, companies have grappled with the complexities of making innovative biopharmaceuticals on a large scale. Success in manufacturing begins with process science, since biotech production requires perfection in maintaining living organisms in a sterile environment under controlled physiological conditions. But unless companies can solve the challenge of planning for and managing manufacturing capacity, they will not be able to achieve the full potential of promising biotech products.
Sep 01, 2007
BioPharm International
In analyzing the industry's current challenges, let's be careful before extrapolating about what they mean.
Feb 02, 2007
BioPharm International
These articles encapsulate the past, present, and possible future of process-scale chromatography in biopharmaceutical production.
Nov 01, 2006
BioPharm International
This article shows how Probabilistic Tolerance Intervals of the form, "We are 99% confident that 99% of the measurements will fall within the calculated tolerance limits" can be used to set acceptance limits using production data that are approximately Normally distributed. If the production measurements are concentrations of residual compounds that are present in very low concentrations, it may be appropriate to set acceptance limits by fitting a Poisson or an Exponential Distribution.
Sep 02, 2006
BioPharm International
Development reports document process development and support the design of validation experiments, yet in many firms training is not provided nor are expectations established. This article describes how project managers can help scientists master the art of report-writing.
Aug 01, 2006
BioPharm International
By BioPharm International Editors
Capital investments in production plants represent a significant portion of the cost of new recombinant drugs
Mar 01, 2006
BioPharm International
By BioPharm International Editors
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
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