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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.”

College football’s calendar in 2024 delivers 14 weeks instead of 13 between the Labor Day and Thanksgiving weekends, meaning schools will have two bye weeks instead of one.

This week Navy and Virginia Tech — who takes its bye before a Thursday night game like NFL teams should — are off while Maryland and James Madison play weekday night games, giving us a sparsely populated local Saturday. And that’s a good thing because there are more than enough major matchups that warrant our complete attention.

While the best showdown technically might be the evening affair between No. 2 Ohio State and No. 3 Oregon, the biggest game, as is often the case on the second Saturday of October, is Texas vs. Oklahoma. The top-ranked Longhorns face the one-loss Sooners under the SEC banner for the first time, but the intense rivalry has survived multiple conference changes for both schools. And once again this game will have conference as well as national implications.

But for many, this showdown will be merely a side dish as the Texas State Fair is in full swing, and as a public service to our readers we touch upon the award-winning foods once again this fall. All descriptions are courtesy of the State Fair of Texas’ Big Tex Choice Awards, and once again it’s kind of understood that each of these items is fried, deep fried or double-deep fried.

As the team with the higher ranking that has lost five times over the last 11 years, we recognize that “every dog has its day.” So, we kick off with the Dominican Fritura Dog. “This savory dish brings an explosion of flavor that starts with fritura cheese and Dominican salami. Split open and topped with garlic plantain chips, top-secret Dominican sauce, and cilantro.”

For those looking for a “lighter salad-like item” there’s The Drowning Taquitos.

“Served in a cup, these fresh, hand-rolled corn tortillas are stuffed with tender shredded chicken and then deep-fried to perfection. To further encapsulate the savory flavor, the taquitos are then ‘drowned’ with a tangy cream sauce, jalapeño, guacamole salsa, shredded lettuce, avocado, tomatillo, pico, and Cotija cheese.” See, I told you there was lettuce in the equation!

Finally, for those looking for something appropriate for breakfast, lunch or dinner there’s the Hot Chick-in Pancake Poppers. “Authentic Nashville hot chicken and pimento cheese are rolled into a ball, dunked into pancake batter, and fried to a golden brown, then topped with a drizzle of Sriracha honey and a sprinkle of Nashville hot powdered sugar.”

What else do you need? Outside of TUMS …

Thursday’s Game

James Madison (4-1, 0-1 Sun Belt) vs Coastal Carolina (4-1, 1-0), 7:30 p.m., ESPN2

There’s a saying you can’t let a team beat you two weeks in a row, and JMU must put the sting of its two-point defeat at UL Monroe out of its system two days earlier than normal with a Thursday night game. These two teams have previously played in late November, and the games haven’t been close with the Dukes winning 47-7 in 2022 and 56-14 last year.

But the Chanticleers have the hot hand in quarterback Ethan Vasko, who’s coming off a career-high 367 yards passing in a win over Old Dominion. But he’s no Alonza Barnett III, who hasn’t thrown an interception since August. The key matchup pits the JMU pass rush (third in the SBC with 13 sacks) against a Coastal offensive line that’s allowed three sacks (fewest in the conference).

Presto’s Pick: Dukes rebound with a 31-17 win.

Friday’s Game

Maryland (3-2, 0-2 Big Ten) vs Northwestern (2-3, 0-2), 8 p.m., FOX

Both teams enter this game off losses to unbeaten Indiana after being close at the half, with the Terps having to spend their bye week stewing in their defeat at the Hoosiers. The Wildcats have won three of four games in this series, and for a dose of déjà vu they upset Maryland last season when the Terps were coming off their bye week. Offensively they’ve yet to hit their stride, ranking 17th in the Big Ten in scoring thanks to the balance of the 15th best ground game and 15th best passing attack.

Northwestern’s defense allows over 250 yards passing per game, but Maryland wide receivers Kaden Prather and Tai Felton are question marks for the contest. Coach Mike Locksley mentioned this week that they’ve had issues in the “middle eight,” in effect the final possessions of the first half and opening possession of the third quarter. He also cites the big play differential — the lack of explosive plays for the offense and too many allowed by the defense — as what’s holding this team back.

Can the Terps begin the “middle eight” of their schedule with a strong showing?

Presto’s Pick: TGIF stands for “Terrapins Get in Focus” as they win 31-17.

Saturday’s Game: Virginia (4-1, 2-0 ACC) vs Louisville (3-2, 1-1), 3:30 p.m., ACCN

The Cavaliers aren’t holding parades in Charlottesville, but they’ve already won more games this fall than they did in the two previous years under head coach Tony Elliott. The Cardinals have lost two straight after being ranked as high as No. 15, but they still boast the best defense in the ACC on third down (allowing 27% conversions) while U.Va.’s 33.8% offensive efficiency ranks 15th in the conference.

The Cardinals also bring a competent quarterback in sixth-year senior Tyler Shough, who has shown off his arm for two other schools (Oregon and Texas Tech) before landing in the Bluegrass State. Can U.Va. deliver a repeat showing of its defensive gem pitched against Boston College last weekend?

Kippy and Buffy have a long-standing rule not to repeat wine choices during the tailgate season, while also understanding that, despite the movie “Sideways,” a good merlot can go a long way. That’s why they’re going with a bottle of 2021 Decoy Merlot.

“Beautifully lush and expressive, this alluring Merlot draws you in with aromas of black currant, black cherry, boysenberry and sweet baking spices,” the winery website reads. “On the palate, it is plush and polished, with silky tannins carrying the luxurious dark berry, creamy mocha and bittersweet chocolate flavors to a long, supple finish.”

Presto’s Pick: Cavaliers are spun sideways in 28-21 loss.

Last Week: 3-4. The late-season frost arrives early. Season: 34-18.

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