10 December 2008
Major study on biologic drug market available from URCH Publishing
Today, URCH Publishing Ltd announces the availability of a major new market report on biologic drugs. Quality for Biologics 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
