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Organic process research and development--fifth international conference
1Chemical and Analytical Development, Novartis Pharma AG, Lichtstrasse 35, CH-4002 Basel, Switzerland. thomas.allmendinger@pharma.novartis.com
Idrugs : the Investigational Drugs Journal
|June 3, 2005
Summary
This study focuses on scaling up the production of pharmaceutical compounds for various conditions, emphasizing efficient chemical synthesis and engineering for cost-effective manufacturing. Key strategies include process optimization and early problem detection to ensure successful large-scale drug development.
Area of Science:
- Pharmaceutical Chemistry
- Chemical Engineering
- Process Development
Background:
- Drug development efforts targeted antitumor, antifungal, obesity, urge incontinence, glaucoma, and retinopathy treatments.
- Previous research lacked detailed biological activity and clinical performance data for these compounds.
Purpose of the Study:
- To detail gram-to-ton-scale preparation of pharmaceutical compounds.
- To emphasize route development, optimization, and scale-up challenges in drug manufacturing.
Main Methods:
- High-throughput optimization using statistical and automated laboratory tools.
- Application of a 'bottom-up approach' for direct drop process design.
- Detailed cost calculations for route selection and process improvement.
Main Results:
- Discussion of chemical and engineering details for large-scale preparation.
- Identification of strategies to prevent scale-up problems through chemist-engineer collaboration.
- Exploration of methods for generating enantiomerically pure compounds.
Conclusions:
- Efficient and economic isolation of reaction products is achievable through optimized processes.
- Cost calculations are crucial for selecting viable drug manufacturing routes.
- A collaborative 'bottom-up approach' facilitates successful scale-up in pharmaceutical production.