Repligen connects with EMT for its leakproof silicone tubing

WALTHAM, Mass.—Whether researching gene therapy, developing a therapeutic drug for a debilitating illness or discovering a possible vaccine for COVID-19, there is a need for bioprocessing tools and technologies every step of the way.

And while there have been larger acquisitions in the past for Repligen, a global bioprocessing company with nine manufacturing centers around the world to solve such bioprocessing problems, the addition of Albany, N.Y.-based Engineered Molding Technologies will help fill a crucial gap for Repligen in the filtration and purification realms of drug development.

"This is a smaller but important component of the bioprocessing system," said Sondra Newman, global head of investor relations at Waltham-based Repligen. "We are acquiring them because they are experts at what they do."

The companies announced June 29 that the transaction is expected to close in the third quarter of 2020. Financial details of the acquisition were not disclosed.

EMT, with 20,000 square feet and 50 employees, will bring its expertise in custom- and over-molded silicone products, including single-use tubes, connections and end pieces, to Repligen's portfolio. All EMT employees, including the president, are expected to be retained, bringing Repligen's total global work force to around 840 employees, the company said.

EMT is expected to bring between $7 million and $8 million per year in revenue to Repligen, and Repligen reported in its first quarter financial report that it expects to grow by 25 percent in 2021—well above the industry average—because of acquisitions like EMT.

Repligen estimates between $309 million and $319 million in total revenue in 2020, according to Newman.

Though Repligen officials said it is not yet known how the EMT products might be branded, Repligen traditionally has used a hybrid for the brand names of its larger acquisitions, such as Spectrum LifeSciences L.L.C.-A Repligen brand; or C Technologies Inc.-A Repligen company.

Repligen ultimately has branded its smaller acquisitions with an exclusively Repligen moniker or trademarked product label.

EMT's standard, custom-molded and over-molded assemblies and silicone tubing products are "key components in single-use filtration and chromatography systems," according to Repligen, and now allow the company to control its supply of such high-end silicone tube and connection products in-house.

"The acquisition of EMT expands our line of single-use ProConnex flow paths, streamlines our supply chain for (alternate tangential flow), and gives us more flexibility as we scale and expand our single-use and systems portfolios," said Tony J. Hunt, president and CEO of Repligen.

The EMT portfolio also enables Repligen to offer bioprocessing customers faster lead times on single-use flow path solutions and provides downstream biopharmaceutical and contract development and manufacturing organization customers with a more complete product offering in filtration and chromatography.

EMT, which specializes in high value, low- to mid-volume silicone connective solutions, receives 90 percent of its revenue from OEMs, including Repligen, and 10 percent from direct customers, such as biopharma and CDMO customers.

"Over the last 10 years, EMT has grown to become a key player in the supply of extruded and molded silicone products in the bioprocessing industry," said Michael Pandori, co-founder of Engineered Molding Technology, established in 2010. "We are at a transition point now where it makes sense to join forces with Repligen, which has an impressive history of scaling companies to the next level."

For EMT, this means taking its products global, expanding its commercial footprint and integrating select EMT technologies into Repligen product lines—all while continuing to innovate.

"We can bring to them our resources, technology and improve their exposure, and they, in turn, give us access to a customer base that we did not have before," Newman said.

Repligen's four businesses—one OEM unit in proteins; and three direct businesses in filtration, chromatography and process analytics—work in upstream filtration, perfusion and clarification processes, as well as downstream in purification, packaging and analytics.

Newman said she expects EMT's custom over-molded silicone products to play a crucial role—"a bridge"—in both its upstream refinement in the drug development process (using its alternate tangential flow and tangential flow filtration systems) and the downstream processes (using pre-packed chromatography columns), from the process validation stage to the commercial sale of the drug product.

Previous legacy silicone connections used a cable tie or a barblock connection, which did not offer a true seal between hoses. Leak-proof flow paths—accomplished by silicone over-molding—are crucial in gene therapy and in the development of vaccines, Repligen said.

"It really is a bridge between the two," Newman said, likening the EMT acquisition to the completion of a home entertainment system. "If you already have your Bose speakers and your stereo system, you want the most efficient, best products to complete the system. That's what EMT brings to us."

In the fight against coronavirus

Many of Repligen's tools, technology and processes already are being used in the fight against the coronavirus, systems that extract crucial materials that drug companies can use to make lifesaving drugs—even, perhaps, a lifesaving vaccine for the coronavirus.

The company even has a COVID-19 hotline on its website, allowing for accelerated timelines for customers on the front lines of the bioprocessing and biopharma battles against the virus.

"The pandemic and the urgency around development of vaccines and antibody-based products has resulted in increased demand for our products, particularly filtration and chromatography, and proteins," Newman said. "Process analytics product adoption is more hands-on (on site setups and demos), and while we are not seeing increased demand for these products, we nonetheless have retained strong growth projections for the year."

Within the vaccine world, Repligen works in cell culture bioprocessing equipment, with TFF systems and hollow fiber filters; purification (chromatography) with TFF and hollow fiber filters, as well as pre-packed chromatography columns; and formulation, through concentration and diafiltration.

Repligen noted that there are different manufacturing methods to produce vaccine antigens, the substance that triggers an immune response in the human body to produce antibodies.

The safety and effectiveness of vaccines produced using embryonic eggs are well established, Repligen said, such as vaccines for the seasonal flu. This method takes about four months to produce a batch of vaccines for each new strain of the virus, according to the company.

Repligen said that in the 1990s, vaccine manufacturing methods were developed using cells from mammals to culture the virus for vaccine production. Various pharmaceutical companies use different sources of mammalian cell cultures for the vaccine production, according to Repligen.

And what is especially unique for a company like Repligen is that it must battle the virus with its innovation and bioprocessing, all while the virus is fighting back inside the walls of the company's facilities.

"We have responded to the pandemic by having all employees work remotely with the exception of those essential to production/manufacturing," Newman said. "We have taken all recommended steps, plus signage, distancing, having a limited number of people in facilities, wearing masks at all times, temperature testing on entry, and so on.

"We want to stay ahead of the situation and ensure that we can keep delivering critical products to our customers, with priority lead times on products for COVID-related programs."

Repligen was founded in 1981 by Alexander Rich and Paul Schimmel. Its subsidiaries include EMT, Spectrum LifeSciences, C Technologies, Refine Technology, L.L.C., Spectrum Europe B.V. and a host of Repligen-monikered sites around the world.

EMT included, the company maintains around 415,000 square feet of production space at its facilities in Waltham (108,000 sq.-ft.-headquarters); Marlboro, Mass. (64,000 square feet); and Lund, Sweden (45,000 square feet); as well as production sites in Bridgewater, N.J.; Ravensburg, Germany; and Breda, Netherlands.

Products are marketed through a direct commercial organization in the U.S., Europe and Asia, as well as through strategic partners and distributors in select markets, Repligen said.