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Advances in drug potency and tailored therapeutics are promoting pharmaceutical manufacturing to transition from a traditional batch paradigm to more flexible continuous processing. Here we report the development of a multistep continuous-flow CGMP (current good manufacturing practices) process that produced 24 kilograms of prexasertib monolactate monohydrate suitable for use in human clinical trials. Eight continuous unit operations were conducted to produce the target at roughly 3 kilograms per day using small continuous reactors, extractors, evaporators, crystallizers, and filters in laboratory fume hoods. Success was enabled by advances in chemistry, engineering, analytical science, process modeling, and equipment design. Substantial technical and business drivers were identified, which merited the continuous process. The continuous process afforded improved performance and safety relative to batch processes and also improved containment of a highly potent compound.

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The use of the Monte Carlo method in radiative heat transfer is reviewed. The review covers surface-surface, enclosure, and participating media problems. Discussion is included of research on the fundamentals of the method and on applications to surface-surface interchange in enclosures, exchange between surfaces with roughness characteristics, determination of configuration factors, inverse design, transfer through packed beds and fiber layers, participating media, scattering, hybrid methods, spectrally dependent problems including media with line structure, effects of using parallel algorithms, practical applications, and extensions of the method. Conclusions are presented on needed future work and the place of Monte Carlo techniques in radiative heat transfer computations. Journal of Heat TransferCopyright © 1998 by ASME AUGUST 1998, Vol. 120 / 547 Downloaded From: http://heattransfer.asmedigitalcollection.asme.org/ on 06/10/2015 Terms of Use: http://asme.org/terms Journal of Heat Transfer AUGUST 1998, Vol. 120 / 549 Downloaded From: http://heattransfer.asmedigitalcollection.asme.org/ on 06/10/2015 Terms of Use: http://asme.org/terms ConclusionsIt is clear that a large volume of literature has appeared over the last 30 years on the fundamentals and applications of the