Rockville, MD—MilliporeSigma rolled out the proverbial red carpet, state and local dignitaries, Maryland crab cakes, and a giant scissors with which to cut a company-branded yellow ribbon as it celebrated the official opening of its impressive new Biosafety Testing facility in Rockville, Maryland.

Maryland Democratic congressman Jamie Raskin was among the special guests invited to mark the occasion. Raskin said the new facility was a big deal “for the company and really for the country.” He read a brief official Congressional Proclamation, which he said had been easy to pass because, with Congress officially on recess, “nobody else was there!”

The event was also attended by guests from several MilliporeSigma clients, including Lexeo Therapeutics, BioNTech, and Kite Pharma, to name a few. (MilliporeSigma, lest there be any confusion, is the North America Life Science business of Merck KGaA, Darmstadt, Germany.)

Introducing the opening ceremony, Pedro Diaz, Rockville site head, said the new facility was designed to help ensure the safety of the world’s medicines. In a short video, Matthias Heinzel, PhD, CEO, life science at Merck KGaA, Darmstadt, Germany, praised Maryland for being home to “a vibrant science and technology ecosystem” including the National Institutes of Health, the U.S. Food and Drug Administration, and a traditionally vibrant biotech cluster. The new facility was “a milestone for global biosafety testing and our entire company,” Heinzel said, who oversees 50 global manufacturing and testing sites around the world, including biosafety testing centers in Shanghai, Singapore, and a pair of sites in Scotland (Stirling and Glasgow).

Boston-based Benjamin Hein, head of life science services in the Life Science business, said the company now had the capacity to offer testing from preclinical to commercial, “impacting every step of the client’s journey.” Hein predicted that the testing facility would become a “global center of excellence for innovation” that would foster greater collaboration between staff and with clients, automation and digitization.

Heather Ahlborn, PhD, senior VP and head of contract testing services, said the building marked a new chapter in Maryland biotech, which had made major contributions in diverse areas such as human genome sequencing, ebola testing, and testing cell therapy protocols for clinical trials. It was also “the single largest investment in biosafety testing in the company’s history.” Karen Madden, chief technology officer at MilliporeSigma, said the center would help the company “become the partner of choice” in a range of “Star Trek” technology products and services, including monoclonal antibody production as well as RNA, cell and gene therapy, catalyzing “a profound shift to more personalized and precision medicine.”

Among the newer initiatives was developing the lab of the future; next-gen biology; AI and sustainability. The new facility would tackle major challenges including CAR-T manufacturing—“think about how not scalable that currently is,” Madden said. Also, reducing the variability of viral vectors, scalability, safety and efficacy.

Timothy Fenn, VP of analytical development at Lexeo Therapeutics, offered a client’s perspective. Lexeo has three gene therapy programs in the clinic, including two in heart disease and one for Alzheimer’s disease. Fenn underscored how different disease areas require a huge range of viral vector quantities. Meeting the annual demand for spinal muscular atrophy, for example, would require about 100 2,000-liter batches/year, Fenn estimated, requiring a staggering amount of resources and quality control. In partnership with MilliporeSigma, Lexeo is pursuing a strategy (published in Human Gene Therapy) using baculovirus infection of insect Sf9 cells, which Fenn described as a simpler and higher-yield workflow than triple-plasmid infection of HEK293 cells.

Building specs

The new 23,000-square-meter facility, built on a vacant plot of land, will house MilliporeSigma’s biosafety testing, analytical development, and cell banking manufacturing services. The cost of the new six-floor building was put at $286 million. (If any funds were left over, they will probably go into fixing the PA system, which stubbornly refused to cooperate during the morning ceremonies.)

Staff and equipment from four old MilliporeSigma buildings, all within a 1–2 mile radius, are in the process of moving into the new facility. Company officials expect up to 300 new positions, which would take the site headcount above 1,000 staff.

A brief guided tour of the facility reveals voluminous lab space—with wings devoted to next-gen sequencing, molecular biology, and more. Most of the labs are still waiting for equipment and personnel to arrive in the coming weeks and months. There is also plenty of shell space for future expansion. Wall monitors—or “digital windows” as our guide nicely termed them—will give clients the ability to scrutinize operations without actually entering labs and disturbing staff scientists.

There is also an emphasis on open-concept communal areas where staff can mingle and hold impromptu discussions. Throughout the building, the color scheme follows MilliporeSigma’s bold image makeover from 2012, with entire walls painted one of the company’s 16 official branded colors. (The schema appears to continue inside the labs as well.)

The new facility is the largest investment in contract testing in the company’s history, reflecting a commitment to provide disruptive platforms that “shorten biosafety testing timelines, meet the growing global demand, and ensure the safety of the world’s medicines for patients,” said Hein.

The Rockville site will feature advanced testing capabilities, including a rapid methods package that is designed to accelerate virus testing. By combining the Blazar^® CHO Animal Origin Free panel for detecting virus families with other assays for mycoplasma, sterility, and retrovirus-like particle detection, results can be obtained in just 14 days, less than half the time using traditional methods. The portfolio also includes the recently launched Aptegra™ platform, an all-in-one, validated genetic stability assay.

Science is a team sport

In an interview with GEN after the formal reception and ribbon-cutting ceremony, Hein was eager to lay out his vision for the new center: “We really believe in the pharma and biotech industries. We have a more than 75 years’ track record… It all started here in Rockville. We feel committed to the location…We believe the market is growing in double digits over the next couple of years to come.”

Hein said his team saw the “criticality of testing services” during the COVID pandemic. “Patients are depending on it. We make sure medicines are safe and [of] high quality,“ he said. The company’s steady growth, fueled by serial acquisitions over the past few decades, meant that the Rockville cluster was running out of space, imposing limitations “from an innovation perspective, an automation perspective [and] a digitalization perspective.” But Hein and his colleagues believed in the industry and “the power of science, technology and innovation…We wanted to double down on it.”

Bringing disparate facilities under one roof should fuel growth for several years to come. The emergence of modalities such as cell and gene therapies and mRNA therapeutics “brings totally different testing challenges,” Hein said. “We need to be really very fast but at the same time… we have to work with regulators… We believe all of that can happen better by being together in one integrated hub rather than spread across multiple locations.”

“Science is a team sport,” said Ahlborn. “We all stand on the shoulders of one another.” Staff were already having conversations that didn’t occur before because their labs were in different buildings. It should also make talent recruitment much easier.

The leadership team expects to reap benefits in assay automation, AI and image analysis, and develop synergies between the testing group in Rockville and the biomanufacturing group. The company also predicts there will be less and less animal usage throughout the portfolio. Thousands of animals have already been saved.

Hein says the new center will enable MilliporeSigma to be more customer-centric. Not only will the collaboration feel tighter with clients, but it will help solve regulatory challenges. A third area of benefit is in major automation. “The beauty of this building is we were able to design it from scratch,” Hein said. “All the workflows, we designed them exactly how we need them to be in the future.”