70 TABLETING
Continuous manufacturing advances T
Richard Steiner reports on the changing face of drug development and production
he opportunity to obtain more data from less product during
development and eliminate the cost and risk of batch-based scale- up has inspired the introduction of small-scale, continuous equipment that can process small quantities of material during R&D while also being able to operate for variable lengths of time to match market demand during commercial production. GEA believes that the
ongoing growth of small-scale, continuous manufacturing (CM) systems will represent one of
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the most important paradigm shifts in pharmaceutical drug production. Flexible development options will facilitate the commercial manufacturing process and enable greater process understanding to be achieved with smaller quantities of material. For more than 20 years, the batch-based production of blockbuster solid dosage forms dominated the industry. Profitability was such that companies were not incentivised to innovate or risk developing new manufacturing technology. In the post-blockbuster era, however, it is increasingly recognised that material costs during drug development are considerable, new drug products are likely to be manufactured in much smaller quantities and that, for novel treatments, the
development of a commercial manufacturing process is not guaranteed. Such pressures have put the costs, risks and timelines associated with traditional batch-based development and manufacturing under scrutiny. In most industries, CM is seen as the low-cost solution to producing low value, high volume products in which there is little need to focus on the cost of materials used in process development and, often, little need for product changeover.
Industry support Regulators are increasingly supportive of CM and manufacturers are recognising that current quality assurance costs are disproportionately large compared with other industries, wherein the production, detection and removal of
GEA offers flexible development options that facilitate CM processes
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