New PDF release: Active Pharmaceutical Ingredients - Devel., Mfg, Regul.

By S. Nusim

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Obtain process data to support process design and the development of procedures for the eventual manufacture of the drug; Process Development 47 5. demonstrate process performance at a scale that minimizes risk and the need to trigger scale-up constraints upon first manufacture. Of the above, only the last seems to require elaboration at this point, as process design is amply discussed in Chapter 3. Thus, given a sufficiently large scale of processing in the pilot environment where the development effort takes place, the transfer to manufacture will be far less likely to entail scale-up risk and, more importantly, far less likely to create a regulatory scale-up issue upon first manufacture.

It is also useful to depict the bulk drug process development cycle on a Cartesian coordinate plane (Fig. 6). The Process Development 21 Figure 5 The three basic tasks of bulk drug process development. These tasks exist concurrently throughout most of the development cycle, albeit their burdens vary through the cycle. Nevertheless, managing well all three tasks as inseparable parts of a single overall endeavor is the principal managerial challenge in bulk drug process development. , kilos of bulk drug made, batches made, or versions of the process piloted).

Such synthesis step, whether using a preparation of the enzyme or the host microorganism, will be considered a chemical synthesis step (a biotransformation or a biocatalytic step) and not a fermentation for biosynthesis. Whichever of these routes is used to obtain a bulk drug constitutes the chemical process. Further processing of the bulk drug to obtain the dosage form constitutes the pharmaceutical process. This distinction is depicted in Fig. 4, where simple 16 Rosas Figure 3 Drugs by total synthesis: Fosfomycin (antibacterial) is a good example of the manufacture of a bulk drug by total synthesis from basic chemicals, albeit the compound is of biosynthesis origin.

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Active Pharmaceutical Ingredients - Devel., Mfg, Regul. by S. Nusim


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