By S. Nussim(ed)
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Additional info for Active Pharmaceutical Ingredients - Development, Mfg. and Regulation
Instead, today’s process chemist must be very alert to what the fine chemicals industry offers (or could be induced to offer) by way of suitable building blocks or intermediates and the corresponding manufacturing capabilities. Such alertness, combined with creative synthesis skills, is the key to truly advantageous routes. This theme is discussed amply and in depth in some of the previous references (2–5), as well as in Saunders’s (11) compendium of selected major drugs. , Ref. 12). In celebrating the opportunities for the creative process chemist, we should not neglect factors such as the increasing desire for environmentally benevolent chemistry (green chemistry) or the prevailing business model in the bulk drug industry, by which the range and scope of chemical processing has been narrowed in favor of contracting out (outsourcing).
Most likely, both technologies eventually have to deal with relatively large volumes of cell mass or plant material waste, and bench work to address those issues is also needed. B. Process Scale-Up 1. What Is Scale-Up? At its simplest, scale-up is the set of processing issues that arise when the same operations take longer to execute in larger scale equipment than at the bench scale. Although such issues do arise, they can be anticipated and in most cases avoided or largely mitigated through changes to the design and operation at the larger scale.
Key duties of this area are to crystallize the final compound as the bulk drug (with the desired chemical and physicochemical attributes). Includes filtration, drying, milling, classification, compacting, blending and packaging. Environ ment is distinctly cleaner than most other areas 3. Aseptic finishing area for bulk drugs (includes solids processing). No chemical processing other than salt formation. Includes all of the above finishing area provisions, but largely in an aseptic processing environment for the preparation of sterile bulk drugs.