No Patent Remedies for Escaping the Cost Pressure
None of the speakers had any patent remedies as to how to escape the cost pressure, but there were plenty of suggestions and examples of best practice, such as the one from Prof. Fernando Muzzio of Rutgers University. Muzzio is the Director of C-SOPS (Engineering Research Center for Structured Organic Particulate Systems) and has been developing continuous processes for particulate matter since 2006 in various applications including pharmaceutical production.
Since 2012 C-SOPS has been operating a production line with Janssen, combining dosing unit, grinder, mixer and tablet press in one continual process. Janssen now wants to build a production line based on the tested design with a view to putting it into operation in 2014. The FDA has also signaled its interest in the demonstration project. Nevertheless, there are still some skeptics because the specter of continuous production has been haunting the sector for some years now with the usual ups and downs associated with new manufacturing techniques. Typical responses therefore include the remarks of one delegate claiming to have been in the industry for 22 years and to have seen all sorts of initiatives come and go.
The efforts to introduce continuous production are centered on particulate production. The greatest leverage also lies in the fact that 80% of all medicinal products are still administered in solid form and therefore began their life cycle as powder at some stage. The potential significance of continuous production has therefore occupied the mind of Dr Ralf Weinekötter of Gericke, who wants to counter the cost pressure with reduced production times. The mixing technology specialist has been interested in the subject of continuous mixing since 1993 and is also at Rutgers University with Muzzio.
Continuous Production Makes its Way into Pharmaceutical Industry
Gericke and Gerteis have developed a continuous line for direct compression which mixes, granulates and compresses, and takes just five minutes to go from compound to tablet. The clever part is to replace the tablet press feed container by a miniature continuous metering/mixing line.
The continuous line has several advantages. There is no need for scale-up because the same line is used regardless of whether six kilograms or 600 kilograms are being made—only the mixing times are lengthened, and the continuous process reduces the risk of segregation as there is no interim storage.
Project efficiency could become the 'make it or break it' factor for pharma companies - read more what the ISPE conference thought about this issue on the next page!
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