MilliporeSigma’s BioReliance® End-to-End Biodevelopment Center Up and Running

This past June saw the official opening of North America’s first BioReliance® End-to-End Biodevelopment Center in Burlington, MA. BioReliance is part of MilliporeSigma. During the ceremonies MilliporeSigma CEO Udit Batra said, “MilliporeSigma is helping drug manufacturers, from small to large innovator companies, bring life-enhancing medicines and therapies to market—and to patients—faster.”

GEN recently interviewed Andrew Bulpin, Ph.D., executive vice president, process solutions, MilliporeSigma, about what the company is specifically doing to help small and large innovator companies meet the goals Batra listed.

Andrew Bulpin, Ph.D.

Dr. Bulpin: I think about our role on three levels: innovation, expertise, and support. We are responsible for developing the manufacturing process for these life-enhancing therapies. Our product innovation around drug manufacturing, products, and processes improves the efficiency and the productivity of the way that biologics are manufactured today and in the future.

There is a whole lot of noise around next-generation bioprocessing, and that is a big area for product innovation. Ultimately, you can envisage a future where biologics are made in a continuous flow-through fashion by intensifying individual manufacturing steps or unit operations, then compressing and connecting sequential unit operations.

Next-generation processing will have a significant impact on how our customers bring therapies to market and we are uniquely qualified to lead the industry through this evolution and down the path of process intensification. This is a key focus area for us.

In terms of expertise, we collaborate with drug manufacturers of all sizes to help bring drug therapies to market faster. The new End-to-End Biodevelopment Center specializes in solving challenges of small or virtual companies facing significant manufacturing and resource constraints to bring drugs to market. For example, we provide support starting at upstream with cell line development, cell banking, then moving to process development, process optimization, preparation of clinical material, and even in some cases, we do small-scale commercial manufacturing for companies.

If companies do not have the infrastructure or the institutional knowledge or the resources in-house, we can certainly help them get their assets further along the pipeline. The continued uptake of single-use manufacturing has significantly reduced the dollar amount to install a manufacturing facility, providing the opportunity for light-asset investment in terms of capital. This enables companies, particularly smaller ones, to hold on to their assets perhaps longer than they have historically.

The third element is around support. One of the ways we do that is in terms of funding. Our Advance Biotech Grant Program expands our global biotech commitment to help awardees get their therapies to market faster with MilliporeSigma products, services, and expertise. Through the newly expanded grant program, every six months, three recipients around the globe will be awarded a total of $250,000 in free services and products to address their process development challenges. In total, six companies will benefit from MilliporeSigma’s Advance Biotech Grant Program each year.

These companies face significant manufacturing and resource constraints when bringing drugs to market and we are happy to help provide support to keep them moving along and making progress.

GEN: What kinds of technologies are going to be used to overcome the process development challenges to which you referred? Or are you just going to give them the money and let them figure out what they want to do?

Dr. Bulpin: I think a little bit of both. We can share expertise around intensifying some of the more outdated unit operations.

If you think about it, monoclonal antibodies have effectively been made the same way for the past 30 years. There has not been a huge amount of process improvement on the fundamentals. If you look at the upstream space, we can provide support from moving from static stir-tank bioreactors towards perfusion systems.

Last year, we launched the first proprietary perfusion cell culture media specifically designed for perfusion and not for fed-batch approaches. If you consider clarification, we have recently launched a number of different flocculation chemicals and then we have taken our clarification device to be completely animal-origin free. Normally, clarification pods contain diatomaceous earth, and we have removed that and gone completely synthetic, which is obviously a trend the industry is moving toward. This is also where our product support comes into play.

Recently, we acquired Natrix Separations, which has a chromatography platform not based on a classical resin-type approach. It is actually on a hydrogel, which means that the cycle times to get through the hydrogel are significantly quicker—an order of magnitude quicker—than a classical chromatography resin. That means we can scale down devices to a level where even for protein A chromatography, it is now possible to imagine a genuinely single-use protein A product, clearly a bottleneck in moving fully towards single use.

In-line virus inactivation and in-line buffer dilution are other areas for innovation. When you look at fluid management, we now have a single-pass TFF device that will concentrate your feed stream in a continuous flow-through fashion, without the need for large holding tanks.

These are some of the key steps in the evolution to next-generation bioprocessing. We have plenty more in the works in our R&D group and are moving in the right direction. Overall, I’d say MilliporeSigma is defining the future and leading the evolution of drug development and manufacturing of life-enhancing drugs, increasing the quality, safety, and access to patients and at a reduced cost.

It really will be a journey over the next decade, but I do think that the way that biologics are manufactured in 10 years' time will be very different from what we see today. For decades, we have collaborated with our customers to shape how drug production is done today and will continue to shape the possibilities of tomorrow.

GEN: Tell us a little more about how the BioReliance End-to-End® Biodevelopment Center process is going to support North American biotech companies in achieving clinical and commercial success.

Dr. Bulpin: Eighty percent of drugs in the pipeline today originate or are still with emerging biotech companies which typically have significant resource constraints compared with the larger pharmaceutical companies out there in the industry.

As I’ve mentioned, our goal is to work with drug manufacturers to help bring life-enhancing drug therapies to market, faster. Our network of End-to-End Solutions provides a full suite of capabilities, access to the latest technologies, and the expertise of our global footprint. We provide the industry’s most comprehensive portfolio of high-quality products, services, and testing for biopharmaceutical manufacturing and for accelerating clinical development from DNA to market.

I shared earlier that our services go as far upstream as doing cell-line development, cell banking, process development, process optimization, manufacture of clinical material, and manufacture of small-scale commercial material.

We have BioReliance End-to-End Solutions centers in France, Shanghai, and now our third center in Burlington. These facilities provide an opportunity for us to leverage all the institutional knowledge that we have garnered over the decades and translate that into something that can help our customers along their journey, get their molecules and their assets to the next milestone and, hopefully, to commercialization.

Our centers provide a service offering based on single use, so we have a full single-use platform, which is A to Z the products that we sell individually. This gives our clients and customers an opportunity to hold onto their assets longer.

When you consider that 80% of the pipeline originates in the emerging biotech companies, and yet only 64% of them achieve commercial approval, there is clearly a higher attrition rate within emerging biotech than there is in the established companies. We are trying to level the playing field a little bit and bring institutional knowledge, state-of-the-art manufacturing processes and truly partner to help the smaller and virtual companies have every possibility of moving forward and reaching their ultimate potential within the market space.

At the end of the day, many of these emerging biotechs are developing therapies which are in niche indications, smaller indications and, therefore, providing an offering for an unmet need. If we could help in any way to accelerate access to health for some of these untreated and unmet needs, then it has got to be the right move in general. And it is obviously a good move for us as a company.

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