(1888PressRelease)
December 11, 2008 - Today, URCH Publishing Ltd announces the availability of a major new market report on biologic drugs. Quality for Biologics - Critical quality attributes, process & change control, product variation, characterisation, & regulatory concerns http://www.urchpublishing.com/publications/market_trends/quality_biologics.html is a unique 300 page report covering the rapid growth in the market for biologics.
Sales of biologics grew by 20% in 2007, far faster than sales of small molecule drugs, which grew by not much more than 5%. And the number of biologics being launched is continues to grow very rapidly. But biologics are not like small molecules: not only are they more complex to develop, test and produce, but they are more difficult to define which means that maintenance of quality together with safety and efficacy is a major challenge. Product quality can be affected by any change in production such as scale up, site transfer or even the introduction of a new reagent. Ensuring product quality can be expensive, but the price of getting it wrong can be even more costly or even disastrous.
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 quality control
Regulatory authority expectations
Risk management
Comparability concerns
The report features contributions from: USB, Lily, Amgen, Roche, NIBSC, Boehringer Ingelheim, Parexel, Probiogen, NIBRT, LFB, Netherlands Medicines Evaluation Board, Paul Ehrlich Institute, and Genentech
More information about Quality for Biologics priced at £1,495 can be found at:
http://www.urchpublishing.com/publications/market_trends/quality_biologics.html
About URCH Publishing Ltd
URCH Publishing Ltd is an independent business information publisher dedicated to delivering quality information products to the global pharmaceuticals industry. The company is based in London, UK. For more information contact URCH Publishing on +44 (0) 20 7060 1099 or email press[at]urchpublishing.com.
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