: In your opinion what is the current level of adoption of continuous pharmaceutical processing technologies in the industry?
MW: We see that this is an evolution beginning with process intensification and growing over the next five to ten years into a continuous manufacturing process, and is already taking place in the industry. Most of the major bio- and pharmaceutical customers as well as some CMOs clearly see the vast benefits of process intensification and have active programs and dedicated teams in place. According to our market research, it is estimated that roughly 35% of today’s commercial molecules will utilize process intensification methods in the near and mid-term. Our research suggests a larger adoption rate for new molecules in development, with cell line/media optimization and flow-through chromatography being well-established. However, lifecycle products may only adopt elements of intensification to optimize current processes. While many of the companies interviewed for our research have adopted elements of intensification, very few considered their processes fully intensified or continuous.
: What are some barriers that need to be overcome in order to advance the uptake of this technology? On the part of pharmaceutical companies, is it a lack of confidence, a lack of successful examples, or just an unwillingness to change?
MW: Next Generation Processing, as we consider it, is an evolutionary manufacturing approach beginning with unit operation optimization and evolving to connected, intensified processes with the potential of a fully continuous process – hence the uptake of this methodology takes time. Despite the fact that enabling technologies already exist, some still need to be improved and current technological gaps filled. System complexity, in-line monitoring and online analytics (e.g. PAT), or holistic, integrated process development expertise, are only a few known hurdles to adoption. The same applies for regulatory guidance which requires further evolution. For example, how will regulators define a batch in the framework of Next Generation Biomanufacturing? Also, this industry paradigm shift towards Next Generation Processing represents a new mind-set for both management and process developers – even a totally new company culture for some of our stakeholders. The fact that there is no templated approach yet for the successful implementation of Next Generation Bioprocessing, versus a well characterized and heavily regulated pharma industry, may outweigh the clear potential this new way of manufacturing drugs will bring.
: Globally, do you see differences in the adoption of continuous processing techniques/technologies? What has your experience been with the various global regulatory agencies? Have they been supportive? Non-committal?
MW: There is no “one size fits all” solution and no established industry standard for what Next Generation Manufacturing looks like, resulting in substantial diversity. Every organization has their own approach and implementation strategy based on their most critical needs and process bottlenecks. As industry adoption evolves over time, there will likely be an industry accepted template. Regulatory bodies are advocating in favor of Next Generation Processing as they see the high potential of reducing the manual handling of products, as well as for better process control. Finally, we see collaborations between pharma manufacturers, regulatory agencies, industry associations and suppliers as key. A concrete example is the collaboration realized with one of our customers and the FDA on “inline virus spiking for linked polishing steps.” To familiarize the FDA with this novel approach, we presented this Next Generation Processing method to them, in order to prepare for their review when filing the drug. This collaborative model is what is needed to advance the industry.
: As a supplier of techniques, technologies and expertise – what do you see as your role in promoting continuous processing technologies?
MW: Next Generation Processing is innovation through collaboration. It is a powerful triangle encompassing customers, suppliers, regulators, academics, government agencies and industry associations working collaboratively. The approach must be holistic from upstream down to final fill in order to be successful. Suppliers also need to develop truly integrated and automated solutions for our customers, enabling them to achieve their targeted goals for speed to market, cost savings, and quality improvement. Awareness and education through real case studies and practical hands-on training courses can demonstrate the value and promote Next Generation Processing technologies, while installing confidence that this is the right path forward.
: In your opinion, will continuous processing become the preferred method for manufacturing pharmaceuticals? Or, will it become one of several technologies available in a manufacturer’s toolkit?
MW: The industry needs to be much more efficient in how it manufactures and supplies products. Pharmaceutical manufacturing platforms need to be agile, able to adapt to specific requirements, extend capacity rapidly, and able to react to market demand quickly. However, it is critical to remember that continuous processing is not always the goal. Continuous processing is only one potential solution in an effort to increase process flexibility, speed, and quality while lowering cost. We must offer a set of solutions from which the proper technology can be selected to meet the end-user’s goals. The final choice of which process technology or manufacturing approach to take, whether it be hybrid, semi continuous, fully continuous, fed-batch, batch, depends heavily on the desired outcomes and specific situation of each customer. Within our Next Generation Processing program, we truly consider what makes the most sense for our customer’s set of circumstances.
: Finally, can you tell us what you see as the future for continuous processing?
MW: We see this as an evolution that will happen over the next five to ten years, starting with process intensification technologies. As we have an extensive knowledge of our customers’ processes, we can strategically evolve their manufacturing process to fit their growth plans. Flexible, modular and automated facility design, integrated plug-and-play end-to-end solutions, digital tools, and single-use will continue to play a critical role in the future of continuous processing. Broadening up the holistic view of bioprocessing beyond integrated upstream and downstream solutions to include the supply management aspect will also be indispensable in the future to alleviate demand uncertainty.