High Volume Solid Dosage Production
The high-volume or mass production of drugs is a fundamental requirement of the pharmaceutical and life science manufacturing industries, particularly for generic and over-the-counter products. It enables companies to produce goods faster, resulting in more sales, and reduce the overall per unit production cost.
For more than 20 years, the batch-based production of blockbuster solid dosage forms dominated the industry. And GEA has been instrumental in designing, producing and delivering innovative, integrated solutions for every stage of the manufacturing process: from materials handling to tablet coating, automation and monitoring.
Now, however, it is increasingly recognized that material costs during drug development are significant, new drug products are likely to be manufactured in much smaller quantities and that, for novel treatments, the eventual development of a scaled-up commercial manufacturing process is not guaranteed. It’s time to change the model!
The GEA Solution
At GEA, we believe that continuous manufacturing (CM) improves the quality of pharmaceutical end products. 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.
By focusing on quality during the whole product lifecycle, not just “tested in” quality, and by understanding the capability of your processes, managing sources of variability and decreasing any associated risks, we aim to change the paradigm of high-volume drug production.
The Future of OSD Production
GEA has been developing CM solutions for several years and helping customers to develop, evaluate and optimize continuous processing techniques to enable them to bring new products to market faster and cheaper.
Providing increased yields, lower utility consumption and reduced waste, continuous manufacturing presents a new approach to high-volume oral dosage form production and meets the industry’s demands for faster product development, reduced costs, improved production economics and increased manufacturing flexibility.