Company leaders and community officials on Tuesday held a ceremonial groundbreaking at the site of Bionique’s existing 9,459 square-foot building on Fay Brook Lane in the Harrietstown Business Park near the Adirondack Regional Airport, with work on the foundation for the two-floor, 34,000 square foot, 14-lab addition starting behind them.

“This project marks a pivotal moment in our company’s history,” Bionique CEO Gladis Zamparo said.

Zamparo said that while the planning for this expansion started around one year ago, the groundwork for it was laid in the years before, as they built their reputation. She spoke highly of the business’ employees dedication to their work. Since Bionique got its start in Lake Placid in 1990, it has become a leading lab in the global biosafety testing industry.

“Clients are asking us for additional services. They know how we work. They know how tremendous of a service we provide. And they want more,” Zamparo said.

Andy Bailey, who founded the ViruSure portion of the Asahi Kasei medical group which Bionique is a subsidiary of, speaks with Bionique CEO Gladis Zamparo at a groundbreaking event for the Lake Clear lab’s expansion on Tuesday. (Enterprise photo — Aaron Marbone)

Zomparo is “absolutely not” surprised by the company’s growth, she said, adding that every decision they’ve made has been deliberate.

“We don’t just improvise,” she added.

Bionique provides mycoplasma bacteria detection for biopharmaceutical products before they are sold to consumers.

This past December, Zamparo said they were running out of space. Along with expanding their mycoplasma detection, the company is also looking to move into sterility and endotoxin testing, tests also required by the U.S. Food and Drug Administration for medications.

Currently, these medications come to Bionique for mycoplasma testing and then go elsewhere for sterility and endotoxin testing. Zamparo said this expansion will let them do all three in the same place.

From left, Alison Webbinaro from Gov. Kathy Hochul’s office, Jill Mariano from Bionique, Bionique CEO Gladis Zamparo, Andy Bailey from Asahi Kasei, Harrietstown town Supervisor Jordanna Mallach and Harrietstown Councilman and CEO of the Franklin County IDA Jeremy Evans hold shovels at Bionique Testing Laboratories on Tuesday, as construction on an expansion to the labs is underway. (Enterprise photo — Aaron Marbone)

In the past decade, Zamparo said numerous cell and gene therapies for treating health conditions ranging from genetic disorders to cancer have started clinical trials. The FDA has approved a couple dozen recently. She said these cell and gene therapies are “the fastest growing segment of the life science industry.”

“Bionique is in a unique position to cater to this industry,” she said in December. “All these therapies need to be screened for mycoplasma.”

The company has 50 employees right now. Zamparo said they plan to eventually employ 90 people.

“People should be keeping an eye on Bionique,” she said.

The construction project will also include improvements to the existing building. Zamparo estimated that construction will take 12 to 18 months.

From left, Rachel Karp from the Saranac Lake Area Chamber of Commerce, Garry Douglas from the North Country Chamber of Commerce, Alison Webbinaro from Gov. Kathy Hochul’s office, Jill Mariano from Bionique, Bionique CEO Gladis Zamparo, Andy Bailey from Asahi Kasei, Harrietstown town Supervisor Jordanna Mallach, Harrietstown Councilman and CEO of the Franklin County IDA Jeremy Evans and Franklin County Legislator Lindy Ellis hold shovels at Bionique Testing Laboratories on Tuesday, as construction on an expansion to the labs is underway. (Enterprise photo — Aaron Marbone)

Adirondack Park Agency staff approved the project in November without feeling the project needed an APA board vote.

The company also opened offices on Main Street in Saranac Lake in 2020.

Bionique was acquired by the Japanese chemical company Asahi Kasei in 2021, which provided them with the funding to support this growth.

Founded by Daniel and Judith Lundin in 1990, Bionique was one of numerous startup biotech companies cultivated at the former W. Alton Jones Cell Science Center in Lake Placid.

Its first home was a small cabin on the Bloomingdale Road outside of town. It later moved to Harrietstown’s business park in Lake Clear.

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What does Bionique do?

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Mycoplasma are bacteria that line the throat and lungs and cause respiratory illness — most commonly the illness known as “walking pneumonia.” They don’t have cell walls, so they’re immune to antibiotics and often grow in antibiotic cell cultures grown in labs for study or production. Mycoplasma is referred to as a “covert contaminant.” According to Bionique’s website, mycoplasma was discovered in 1956, when contamination was common — between 57% to 92% of cultures were contaminated with the bacteria. Now there are laws to keep patients safe.

Under U.S. and global laws, every one of these drugs is required to be tested for mycoplasma bacteria throughout each stage of its development and manufacturing.

Every time a manufacturer creates a new batch of a drug, it sends a sample out for mycoplasma contamination testing. Bionique is the only lab in the U.S. solely dedicated to testing for mycoplasmas, and one of only two with such a focus on the planet. Zamparo previously estimated that half of the general population has taken some drug, treatment, medication or vaccine which was tested in a Bionique lab.

Its clients include eight of the top 20 global cell and gene companies in terms of 2022 total revenue. She said in the past year, Bionique has done work for 35% of the top 20 global cell and gene therapy companies.