Continuous manufacturing has long been touted as the future of drug production. Pharmafile approached Novartis for more details about its successes in the area, and the challenges, of developing the new process.
Why did Novartis decide to take the step to experiment in continuous manufacturing processes?
In a rapidly evolving industry climate, Novartis is leading the drive for more innovative production and manufacturing solutions. Current drug manufacturing – the "batch method" – can be a laborious, segmented process, requiring significant time, resources and financial investments. Before reaching a patient, products often pass through multiple phases of manufacturing at various facilities across hundreds of miles before being ready for distribution. Novartis – recognising the need to deliver treatments to patients faster and more efficiently, and the limitations of the current manufacturing process to meet those needs – is working to transform the pharmaceutical development and manufacturing process through continuous manufacturing.
What are the advantages to continuous manufacturing?
The innovative continuous manufacturing process integrates all steps of production from start to finish into a single process in one location, allowing for strong quality control, lower costs and better production speed. Additionally, when compared to the batch method, continuous manufacturing:
- Runs 24 hours, seven days a week with very brief throughput times. By comparison, the current method is continuously interrupted and requires roughly a year just to produce one batch of pharmaceutical products. Continuous manufacturing shortens the development and manufacturing time, which means medicines get to patients sooner and production costs are reduced
- Strengthens product quality and reliability through the sequential but continuous processing of small amounts of material rather than simultaneous processing of a few large amounts, which allows for much more stringent process control throughout each step
- Uses smaller equipment, infrastructure, and buildings, removing costly and inefficient heavy machinery from the production cycle. The entire operation can be completed in one room
- Reduces carbon footprint by eliminating process interruptions, intermediate storage needs, and material transport
There was a lot of talk and speculation regarding continuous manufacturing last year but it seems to have gone quiet recently. Is this due to companies working on the actual technology and infrastructure involved, or is progress stalling?
At Novartis, we remain more committed than ever to the continuous manufacturing process, and continue to see progress in this area. This continues to be an area of great priority to our company, and is the wave of the future of manufacturing. We don’t feel that progress has in any way stalled or that the excitement surrounding this field has lessened, rather we work in an industry that is highly regulated, and with that comes a certain pace of progress – a pace which most people feel we are on track with.
Novartis entered a 10-year research collaboration programme with the Massachusetts Institute of Technology (MIT) back in 2007 – have there been tangible outcomes to this collaboration?
The partnership established the Novartis-MIT Center for Continuous Manufacturing (CCM). The goal of this ongoing collaboration is to research and develop novel pharmaceutical production techniques. In pioneering this field, we challenged ourselves to be creative and move beyond the traditional ways of manufacturing drugs, and we knew we needed a partner that embodied that outside-the-box style of thinking. That is exactly why we chose to work with MIT to concept this process for the pharmaceutical development sector. We then implemented their learnings, creating our cGMP-compliant pilot facility to produce and supply clinical-trial materials, which includes approximately 3,200 square feet of cGMP space and all newly designed equipment.
You now have a continuous manufacturing facility in Basel – what have you learnt from getting the facility up and runn...
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