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1 Introduction
Pages 7-11

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From page 7...
... Large multinational, research-intensive compa(FDA) launched the Pharmaceutical Quality for the 21st nies represented by trade associations, such as the PharCentury Initiative to encourage adoption of innovative maceutical Research and Manufacturers of America and technologies that would lead to an agile, flexible phar- the Biotechnology Innovation Organization, which tradimaceutical manufacturing sector.1 The goal was to en- tionally have developed and brought to market patented courage a transition to manufacturing processes and ap- drug products.
From page 8...
... To address that tension, scientific literature, and the committee's expertise typi- CDER created the Emerging Technology Program and cally fall into four categories: Team (ETT) , which works with pharmaceutical compa nies that are considering innovations at the early stages to • Specific operations in drug-substance manu- try to reduce barriers to adoption of innovative technolofacturing, including integration of steps through inten- gies.8 Also as part of its efforts, CDER tries to stay abreast sification, use of microfluidic formats, replacement of of technologies that it might see within the timeframe of traditional separation and purification processes with 5–10 years and asked the National Academies to assist it membrane technologies, new synthesis routes involving in that effort.
From page 9...
... of the Food and Drug Administration fosters the adoption of innovative technologies by pharmaceutical companies. To assist CDER in those efforts, an ad hoc committee of the National Academies of Sciences, Engineering, and Medicine will produce a consensus report that identifies emerging and upcoming technologies (e.g., product technologies, manufacturing processes, control and testing strategies, and platform technologies)
From page 10...
... Advanced Manufacturing: Manufacturing developments in which innovative technologies are used to upgrade or replace existing manufacturing systems so as to improve product quality and process performance. Batch Processing: A manufacturing mode in which transformation of input materials occurs in a series of discrete unit operations; each operation involves charging of the unit with input material, processing over some period, releasing the resulting processed material at the end of that period, possibly testing it, and then transferring it in bulk to the next operation.
From page 11...
... Portable Manufacturing: A manufacturing system design in which integrated manufacturing assets are reduced in scale, modularized, and made largely site-independent so as to allow transport and operation of the system at any desired location. Semi-Batch Processing: A semi-batch operation is an inherently batch operation in which there is some addition or removal of material as the batch operation progresses.


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