Scale Up

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
Capital investments in production plants represent a significant portion of the cost of new recombinant drugs
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
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
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.
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