Market forces, capacity constraints, and government policies have driven the bioprocess industry to evaluate new technologies in mAb production with goals to maximize manufacturing flexibility and efficiency while minimizing risk and product cost. Focus is needed on technologies offering the highest return on investment based on ease of implementation, regulatory acceptance, and cost of goods (COG) reduction.
We sat down with Merrilee Whitney, head of the BioContinuum™ Platform for Next Generation Bioprocessing, to hear how MilliporeSigma is addressing the paradigm shift toward intensified, connected and continuous bioprocessing in today’s evolving biopharma industry.
How would you describe today’s biopharma landscape?
We are seeing unprecedented pressures on biomanufacturers: from the incredible amount of growth in the molecules coming through the pipeline to the uncertainty associated with regulatory change and acceptance, coupled with the cost pressure that they are experiencing with an increased number of entrances into the marketplace. As an answer to this evolution, we brought to life the BioContinuum™ Platform representing our belief in and commitment to the change that is happening within the industry, to meet these challenges that our customers are facing.
Is fully connected, fully continuous processing the answer to the challenges biomanufacturers face today?
Nowadays, a lot of the discussion in the industry is around fully connected, fully continuous processing being the answer. Our unique point of view is that this will be an evolution over time, starting with process intensification. As a matter of fact, it is starting right now. There are solutions in our portfolio today that will enable biotherapeutic manufacturers to see real benefits in terms of their cost of goods and facility flexibility. Every solution that we already have in the portfolio and are continuing to develop is designed with a very holistic perspective of not only how all these different solutions work in an mAb process today but also how they can be connected and put together for a fully connected, fully continuous process in the future.
What role is collaboration playing in addressing biomanufacturers’ challenges of today?
Collaboration is going to be key in how we are able to actually realize the benefits of these technologies as an industry. What will be immensely important will be the collaboration between suppliers such as ourselves and biomanufacturers, as well as regulators. There are going to be many unanswered questions that we as an entire industry need to work through together. And as MilliporeSigma is taking a very holistic view to how this evolution in the industry will happen, we are perfectly poised to collaborate with both customers and regulators to bring this vision of Next Generation Bioprocessing to fruition.
What actually is the BioContinuum™ Platform?
As stated earlier, the BioContinuum™ Platform represents our belief in and commitment to the evolution of bioprocessing. Together with our customers and regulators, we strive to accelerate access to biopharmaceuticals for patients worldwide.
Whether developing an intensified, connected or continuous bioprocess, the BioContinuum™ Platform provides the building blocks to help our customers achieve their bioprocessing goals. This holistic and forward-looking view of biomanufacturing actively incorporates connected software, controls and analytics across our portfolio of technologies to make the factory of the future a reality.
The BioContinuum™ Platform is an expanding offering of proven and novel technologies, applications and expertise enabling biotherapeutic manufacturers to confidently enter the era of next-generation processing by delivering increased speed, greater flexibility and enhanced quality while reducing the costs and risks of navigating the evolving biopharma landscape.
What is part of this platform?
The BioContinuum™ Platform comprises several elements. First, there are process intensification–enabling products, integrated solutions and applications, such as perfused seed train, intensified protein A capture, a complete flow-through polishing toolbox or single-pass tangential flow filtration applicable for a multitude of applications. Second, there is a key element around expertise, whether that’s how you implement and validate these technologies in your processes or regulatory aspects where we can work in partnership with the regulators and our customers. Finally, there is a critical element when we start to discuss connecting process steps and getting to a fully continuous process in 5–10 years, which is the software, automation and analytics that’s required to get all of this to work together seamlessly.
What is the value of this platform to end-users? What’s in it for them?
We are working with BioSolve® modeling so that we can develop individual scenarios with our customers to demonstrate actual benefits that can be realized in their particular cases and with their specific challenges. But, across the industry, we are seeing very real and tangible benefits of the adoption of process intensification today: for instance, 90% reduction in facility footprint, 90% reduction in capital expenditure, 70% reduction in the time it will actually take to build one of these facilities of the future. However, it is not just about the facility footprint and construction time, but also on how to positively impact operating expenses moving forward. Some customers have seen as much as a 90% reduction in their operating expense.
Do you have any Final Thoughts?
The final message I would want to leave people with about MilliporeSigma’s BioContinuum™ Platform and where we are as an industry is process intensification is here today and it is real. We are implementing these solutions with our customers right now with very positive impact. That being said, we are developing those solutions with an eye to the future, so if a customer does want to develop a fully connected, fully continuous process in the future, we are developing those building blocks that they can utilize today and tomorrow.
