“The first rule of any technology used in a business is that automation applied to an efficient operation will magnify the efficiency. The second is that automation applied to an inefficient operation will magnify the inefficiency.” — Bill Gates
The drive to improve drug safety and quality and at the same time cut manufacturing costs is stimulating the pharmaceutical industry to look at more structured pharmaceutical development and manufacturing processes.
In ‘The Future of Pharmaceutical Manufacturing Sciences’, Jukka Rantanen and Johannes Khinast* present a comprehensive review of this area, including recent developments related to Quality by Design (QbD) and Process Analytical Technology (PAT) – important tools in taking the industry to the next level. They observe a paradigm shift where engineering principles and product design are guiding pharmaceutical development. And Design of Experiments (DOE) and Multivariate Data Analysis (MVDA) will play a key role in this development.
The authors describe many components of future developments, such as mechanistic process modeling techniques and principles for process measurement and control, concluding with the application of continuous manufacturing in the pharmaceutical industry.
Continuous and semi-continuous manufacturing methods are common in the majority of other industries, such as paper production, automobile manufacture, petroleum and gas production, and food processing, but batch methods currently dominate the manufacture of pharmaceuticals. Batch processing enables non-stop manufacturing, with the flexibility to respond to market needs, but continuous manufacturing would offer the opportunity to attain better, leaner results more quickly and at reduced cost, with minimum waste and a flexible delivery system.
Continuous manufacturing also offers the potential of delivering the flexibility needed to meet the future needs of personalized medicine (drug products for specific patient groups). The authors name Genzyme as one company that is making progress in the continuous manufacture of biologic drugs. Elsewhere, one can learn of the efforts of Novartis, which is in the middle of a 10-year study to develop novel continuous flow manufacturing technologies for pharmaceuticals. The advantages Novartis see include delivering new drugs more quickly through efficient production processes in smaller facilities, creating less waste, consuming less energy and raw materials, and enabling continuous monitoring of drug quality.
As Rantanen and Khinast point out, continuous manufacturing will require well-placed PAT sensors and probes gathering, for example, spectroscopic data and linked to multivariate models to monitor Critical Quality Attributes (CQAs) in real-time, possibly enabling real-time release.
Want to know more about Multivariate Data Analysis processes and tools? Read more about how it works here.
You can also find out more about Design of Experiments here.
* Rantanen, J. and Khinast, J. (2015), The Future of Pharmaceutical Manufacturing Sciences. J. Pharm. Sci. doi: 10.1002/jps.24594