Innovations in Pharmaceutical Manufacturing on the Horizon Technical Challenges, Regulatory Issues, and Recommendations (2021) / Chapter Skim
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5 Innovations in Integrated, Flexible, and Distributed Manufacturing Networks
5 Innovations in Integrated, Flexible, and Distributed Manufacturing Networks
Pages 48-59
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From page 48... ...
Center for Drug Evaluation and Re- and process assessment and handling and in process consearch (CDER) is likely to see substantial innovations in trol and reliability will increasingly integrate the producintegrated, flexible, and distributed manufacturing.
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From page 49... ...
end processes and agile supply strategies can rectify that End-to-end systems are enabling some highly innoproblem by decreasing both raw materials and work-in- vative and relevant approaches to drug manufacturing progress inventories. described later in this chapter, including modular and Although there clearly are opportunities to "right- distributed manufacturing.
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From page 50... ...
Such newfound agility supports production potential to increase efficiency and throughput in tradiscales that enable precision and personalized medicine, tional facilities, a set of potential uses emerges wherein reconfigurable facilities that are responsive to surge re- the modular facility has a small footprint (for example, quirements, and even distributed manufacturing concepts. shipping-container size)
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From page 51... ...
handle reaction conditions of up to 250℃ and pressures reaching 17 atmospheres. Incorporation of various in-line Drivers of Development sensors enables process monitoring and analytic testing of the product, and the resulting data can be used in process- The drivers of the development of highly portable control strategies to maintain optimal conditions within manufacturing systems are largely independent of the fidifferent microchambers by altering reaction conditions nancial drivers typical of pharmaceutical manufacturing.
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From page 52... ...
Small-batch portable manufacturing could also bring down production costs and improve patient ac- Precursor and Supply Chain cess to drugs whenever and wherever they are needed. A critical consideration for all the manufacturing pro Applications cesses, but especially those in systems intended for deploy ment outside a standard cGMP facility environment, is the The potential applications of highly portable manu- supply chain of raw materials, including drug-substance facturing systems are aligned with the drivers of their de- precursors, media and buffer components, assay reagents, velopment and include the following: lyophilized cells, and DNA plasmids.
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From page 53... ...
sessment approaches. The full realization of the agility of end-to-end and modular manufacturing processes is based Highly Complex Molecules not only on the increased capabilities of the manufactur ing processes but on the ability to assess product quality The use of end-to-end and modular systems has the during and after production in a way that matches the eftheoretical benefit of being able to be reconfigured to pro- ficiencies of traditional manufacturing.
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From page 54... ...
Risk-based methods and Integration testing at various levels of integration of the software and hardware can be used.3 The committee recommends that Addressing control challenges in integrated, flexible, regulators become knowledgeable about these methods so and distributed manufacturing processes will require in that they can assess the level of rigor that should be and is novations in software and hardware. According to the used for various systems.
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From page 55... ...
regulations. Nonetheless, there is a need to identify where current regulations need to be updated to handle the level Challenges in the Regulatory Approach of automation that is being explored with integrated, flexible, and distributed manufacturing networks.
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From page 56... ...
Low production • How will analytic standards be defined in systems that produce low volumes of special products and dosage forms, for example, in personalized medicine? volumes • Are there acceptable approaches to enable nondestructive release testing for low-volume production runs?
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From page 57... ...
For end-to-end manufacturing, the primary regula- Regulatory Science and Agency tory guidance will need to describe approaches to qual- Involvement in Phased Approaches ity for systems that do not have typical in-process and release testing and that might have specialized, highly Although guidance documents described above could advanced control systems that are based on innovative in- greatly facilitate implementation of novel manufacturing line testing methods. The typical differentiation between technologies, it is clear that direct FDA involvement with drug substance and final drug product might also pres- implementation could provide important advantages and ent regulatory challenges in end-to-end systems, in which accelerate the use of innovative systems.
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From page 58... ...
In the ment of a useful approach to regulation of modules could context of this report, pharmaceutical companies can probe accelerated if FDA scientists actually used the mod- vide use cases that represent the core characteristics of ules, aided in their development, and formulated guidance their overall processes, similar to proxy applications, and rather than waiting for a regulatory filing and only then the developers of the technology can apply their solutions providing expectations. Innovative regulatory approaches to the specific use cases.
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From page 59... ...
2018. Lean Laggards: Exploring the State of novations in Pharmaceutical Manufacturing, June 2.
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