: In your opinion what is the current level of adoption of continuous pharmaceutical processing technologies in the industry?
SB: There is a significant increase in interest and activity in the biopharmaceutical industry to adopt continuous bioprocessing. Unlike in the pharma industry, there is the need for robust cell lines, viability for extended periods (up to three months) and the ability to express proteins for extended periods of time. This successful combination defines a successful implementation of continuous bioprocessing in biopharma. Though downstream processing was a bottleneck until now, the use of multiple chromatography columns to achieve continuous operation seems to be one of the paths forward. Most of the molecules that are being developed using continuous processing are still in preclinical or initial phases of clinical manufacturing. I expect to see some developed processes for commercialization in the next four to five years.
: 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?
SB: About three years ago, I would have argued that adoption was hindered by the lack of successful examples, but not today. As everyone knows, it takes eight to ten years to successfully launch an approved and innovative molecule. I would attribute the cause to the process and time required. There have been technological challenges, which had to be expected but that are being overcome. Scientific progress in clone development, and cell culture media that express proteins in higher quantities all have an impact as well. Cost has a direct impact on the demand and demand drives innovation. If fed batch cultures produce sufficient quantity to satisfy demand, it limits the need for value offered by continuous processing. This applied to all innovative molecules, biosimilars and bio-betters.
: 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?
SB: Emerging markets are catching up with developed markets in terms of investments. I don’t think access to continuous technologies is a concern irrespective of where one is in the world. From a regulatory perspective, efficacy and safety of the drug are the primary focus. Continuous processing is only an operational strategy. Regulatory is transforming and is supportive as along as a manufacturer provides satisfactory documentation. Regulatory process is non-negotiable and significant efforts made from the regulatory side to support the industry and save the diseased.
: As a supplier of techniques, technologies and expertise – what do you see as your role in promoting continuous processing technologies?
SB: As a leader in Single Use Technologies, Thermo Fisher Scientific has been investing in developing single use platform technologies in both upstream and downstream continuous processing. Biological manufacturers have embraced our open architecture approach and we will continue to collaborate with customers to provide flexible and economical solutions that meet or exceed industry requirements. Making sure our technologies comply with guidelines such as BPOG, BPSA, USP remain part of our primary focus. We will continue to develop and promote automation solutions in continuous processing across all layers like our SmartParts (sensors and devices), SmartSystems (integrated SmartParts, universal hardware, distributed control and flexible software enabling all scales of upstream and downstream processes) and SmartFactory (integrating unit operations into a seamless network).
: 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?
SB: As mentioned earlier, affordable drugs drive demand (quantity), demand drives innovation and adoptability. In my opinion, demand defines manufacturing method for bio-pharmaceuticals. I think continuous processing is one of the answers to derive economical bio-processing strategy and demand defines the biological manufacturing.
: Finally, can you tell us what you see as the future for continuous processing?
SB: Investment in disruptive innovation is today’s mantra. Continuous processing will play a significant role in reducing cost of bio-manufacturing. This is driving investment and innovation in robust process analytics and associated automation. I see a sensible portion of the molecules on the market adopting continuous processing in the next five to ten years in both upstream and downstream processing. Thermo Fisher will remain steadfast in our collaborative approach with customers and suppliers with the implementation of continuous bioprocessing.