The development of small-scale, continuous manufacturing (CM) systems will be one of the most significant changes in the pharmaceutical industry in the next 10 years.
The development of small-scale, continuous manufacturing (CM) systems will be one of the most significant changes in the pharmaceutical industry in the next 10 years. These agile systems will enable commercial manufacturing processes to be developed in much less time, using less product during development and scale-up, but with much greater process understanding.
For more than 20 years, the batch-based production of blockbuster solid dosage forms dominated the industry. Profitability was such that companies were not incentivized to innovate or risk developing new manufacturing technology. However in the post-blockbuster era, it is increasingly recognised that material costs during drug development are significant, new drug products are likely to be manufactured in much smaller quantities and that, for some novel therapies, the development of a commercial manufacturing process may be on the critical timeline.
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 for which there is little need to focus on the cost of materials used in process development and, often, little need for product changeover.
However, the 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.
Regulators are increasingly supportive of CM and manufacturers are recognizing that current quality assurance costs are disproportionately large compared with other industries, where true Six Sigma production capability means that the requirement for end-of-line testing and the removal of out-of-specification product is effectively eliminated. Potential API savings of more than 60% and time-to-market reductions of more than a year have been identified by companies using small-scale CM systems.