Less is More in API Process Development

Operational Excellence & Lean Six Sigma Can each reaction step be completed in minimum time? If not, how can time and costs be reduced? This is a very challenging question, but it must be addressed thoroughly, from the very first step. How will reaction kinetics affect the total reaction time? Kinetics must be evaluated carefully since data will be critical to optimizing the commercial process. Are you selecting the best solvents for the process? Using solvents that offer a maximum density difference between organic and aqueous phases can eliminate the need for brine washing. Will the intermediate require isolation? Can the same solvent be used throughout the process? This is the ideal situation, but if it’s not possible, can the total number of different solvents be minimized? This will have repercussions both for solvent recovery and disposal. Are you replicating commercial conditions in the development process? Can each reaction step be translated easily to an executable unit operation? Lab glassware and configurations are excellent for synthesis but don’t represent reality. Is the process such that it delivers quality product rather than quality is achieved by testing the product? Inside USP’s New Pharmaceutical Ingredient Verification Program Is IT a Catalyst for India’s Drug Industry Growth? Aptuit Acquires Evotec AG's API Business Pfizer CentreSource and ScinoPharm Taiwan to Manufacture Steroid Active Pharmaceutical Ingredients Alpharma Sells API Business to 3i for $395 Million Quantitative Evaluation Of Pharmaceutical Solids Continuous Processing in Pharmaceutical Manufacturing Whistleblower Protections for FDA and Private-Sector Employees From Underperformance to Overachieving: Culture Change at Bayer Berkeley Aseptic Blow-Fill-Seal Technology vs. Traditional Aseptic Processing Ensuring Better Control of Granulation Using OEE and SMED to Reduce Tableting Cycle Time Subscribe to the Magazine » Get the Article RSS Feed » Legal Disclaimers, Terms and Conditions »