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Reportlinker Adds Quality for Biologics
Date:11/3/2010

NEW YORK, Nov. 3, 2010 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Quality for Biologics

http://www.reportlinker.com/p0324749/Quality-for-Biologics.html

Quality for Biologics – New Report

Critical quality attributes, process and change control, product variation, characterisation, and regulatory concerns

Sales of biologics grew by 20% in 2007, far faster than sales of small molecule drugs, which grew by not much more than 5%. The number of biologics being launched is also growing very rapidly, accounting for more than 25% of launches in 2007. But biologics are not like small molecules – they are more complex to develop, test and produce. Any change in production may have a direct effect on both safety and efficacy. Making sure that development, testing and production is done correctly can be expensive, but getting it wrong can be even more expensive and may be disastrous for patients and for the companies involved.

This unique 300 page report can help you to understand the processes involved – knowledge that can save time and money and even make the difference between success and failure.

The report covers all aspects of the subject including

• Critical quality attributes

• Manufacturing process parameters

• Process analytical technology

• Physicochemical analysis,

• Bioassays,

• Formulation and specifications

• Product- and process-related impurities

• Aggregation

• Non-clinical testing

• Clinical development,

• Post-marketing period

• Regula
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