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Quality for Biologics
Biopharm Knowledge Publishing, Jan 2009
Biologic drugs are complicated biological products that are normally difficult to define in molecular terms and that can be inconsistent in their exact composition. This can make it difficult to assure product quality and therefore to ensure safety and efficacy. There is no perfect solution and the commercial cost of quality is high, but the cost of getting it wrong can be considerably greater or even disastrous. Considerable time and expense can be saved by having an educated approach to manufacturing and process development, characterisation and analytical methods, product variation and also to regulatory issues. This unique new report provides a detailed and complete guide to the processes and methods involved.
Quality for Biologics is produced and edited by Nicole Lyscom PhD and is written by top industry experts from leading companies and organisations including:
- Genentech
- Amgen
- Roche
- Eli Lilly
- UCB
- LFB
- Boehringer Ingelheim
- Paul Ehrlich Institute
- Parexel Consulting
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.
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