By Stanley Nusim
This advisor bargains present and well timed discussions of the method improvement cycle, layout engineering, the approval method, qc and insurance, and validation, in addition to plant production actions together with fabrics administration, upkeep, and safeguard.
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Extra resources for Active Pharmaceutical Ingredients. Development, Manufacturing, and Regulation
Fermentation processing. Very distinct in space, equipment and auxiliary facilities (16). Microbiology lab, seed development lab, and fermentor train. Air compression, air and liquids sterilization, tank and piping sterilization. Stirred tank fermentors, feed tanks and harvest tanks 8. Downstream processing of fermentation streams. Also a very distinct processing area: little chemistry but a great deal of work-up, purification and isolation with a different mix of unit operations (17) 9. Intermediate bench=pilot scale lab for engineering studies (not the kilo lab, although it can be readily pressed into preparative duty as appropriate).
Its focus, although not exclusively, is the preparation of limited amounts of bulk drug for assorted preclinical purposes, then followed by first scale-up to support Phase I activities, which include testing the drug in healthy subjects (humans or the target animals if a veterinary drug). Starting with bench scale equipment (up to 100 L in the so-called kilo lab) or pilot scale fermentors (up to 5000 L when titer is low), this early preparative work uses whatever synthetic method or fermentation conditions (the microorganism and the nutrients) are immediately available.
The above ranges probably reflect the adequacy of the tools used to assess the merit of developing an active compound and the rigor of the criteria for moving a compound forward. chemists in the drug industry practice synthetic chemistry as their profession and are oriented downstream (towards the reduction to practice beyond their lab bench), thus the usual discontinuity in synthetic route at the discovery=development boundary. Although sometimes much is made about smoothing and simplifying the discovery synthetic route (eliminating isolations and purification, shortening the processing cycle, and using less expensive materials), the most desirable contribution of the process chemist is the conception of a distinctly advantageous synthesis route that can then be developed and engineered into a sound manufacturing process.