A growing number of biologics are making their way through the research and development pipeline and into the marketplace. Complex technologies surround the manufacture of these products and more efficient and quality processes are needed to reduce risks, costs and time to manufacture these drugs. Continuous manufacturing represents the future however collaboration between suppliers, biomanufacturers and regulators is needed to ensure its success. Andrew Bulpin, Head of Process Solutions, MilliporeSigma discusses key market trends and the role vendors play in the evolution toward next generation processing. –KB
 
Contract Pharma: What are the key market trends and drivers in the biopharma manufacturing space?
 
Andrew Bulpin: MilliporeSigma estimates that by 2025 approximately 30% of the molecules within commercial manufacturing will utilize process intensification technologies.  The conversion of batch processes to continuous manufacturing is the future of the pharmaceutical industry, employing continuous flow, end-to-end integration of manufacturing sub-processes with a significant level of control strategies.  This is all driven by the need in the industry to increase speed and facility flexibility, while reducing risk and cost.
 
CP: What will the factory of the future entail?
 
AB: The current manufacturing process is reduced (aka intensified) from multiple steps to a continuous process involving just a few steps. This intensification also shrinks the size of the manufacturing equipment, so that drugs can be produced in smaller batches versus big, stainless steel vats.
 
In addition, state-of-the-art analytics are integrated as part of this new process, making it easier to monitor production and be alerted to any problems quickly.
 
Single-use or disposable products will also play a big role in the evolution of drug manufacturing, as they are disposed of after each batch and therefore, decrease the risk of contamination as well as reducing the cost and time to build a new facility. 
 
CP: What operational efficiencies can be gained through process intensification?
 
AB: Our unique holistic approach to process intensification allows us to realize benefits of process intensification over the entire process, not gained by focusing on one area at a time.
 
For instance, our Flow-Through Polishing Toolbox provides:
     ·       10% COGS reduction and 47% Buffer reduction for the overall process demonstrated through process modeling
     ·       Opportunity for more batches/year due to significantly decreased process time
                  o   72% decrease in polishing process time
                  o   24% decrease in overall DSP process time
 
A significant 40% reduction in facility footprint is also created by eliminating intermediate hold tanks, single-skid operation and 50% reduction in resins and filtration, as well as 87% less buffer requirement for the polishing operations.
 
Additionally, we have seen industry presentations that show the potential for up to an 80% reduction in facility footprint and 75% reduction in capital.
 
CP:  What role do vendors play in the evolution toward next generation processing?
 
AB: Collaboration is key to advancing this industry evolution. We cannot do it alone. This manufacturing evolution requires three-way collaboration between suppliers, biomanufacturers and regulators – and sometimes even beyond by including academia and industry associations. MilliporeSigma is heavily involved and interested in collaborations: NIIMBL, BPOG, EU Research Program (e.g. Horizon2020).
 
For decades, MilliporeSigma has collaborated with our customers to shape how drug production is done today and will continue to shape the possibilities of tomorrow.