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BioPortfolio | Urch Publishing Reports | Quality for Biologics

Quality 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.

This unique 300 page report will provide you with the information you need to carve your path through this potential minefield - information that can save time and money and 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 quality control

* Regulatory authority expectations

* Risk management

* Comparability concerns

Quality for Biologics is essential reading for corporate management and those in product, process and analytical development, product quality and characterisation, R&D, and regulatory affairs. It is aimed at biotech, big pharma, producers of biosimilars / biogenerics / follow-on biologics, contract manufacturers, providers of analytical services, providers of manufacturing and analytical equipment, regulatory agencies and clinical research organizations. This case-study rich report gives an authoritative, detailed and clear explanation of the issues surrounding quality for biologics, its implications for the market and for the biotech and pharmaceutical industries.

Publication Date December 2008

ISBN n/a

Pages 300

Format: PDF
Table of Contents
Price: $2,295.00 / €1,519.98

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