LAKE CLEAR — Bionique, a local lab with a global impact and a specialty in keeping medicines safe from bacteria, is expanding to meet rising demand in the rapidly-growing cell and gene therapy market. The business recently had its plans to expand its location at the Harrietstown Business Park in Lake Clear approved by the Adirondack Park Agency.
The lab, with offices in Lake Clear and Saranac Lake, is preparing to triple its size — in both its physical space at the Lake Clear site and in its staffing.
“We are running out of our space, literally,” Bionique CEO Gladis Zamparo said. “Right now, we are absolutely constrained by the current footprint. We literally do not have seats.”
Zamparo said in the nearly 34 years Bionique’s been around, since it got its start in Lake Placid in 1990, it has become a leading lab in the global biosafety testing industry. It provides mycoplasma bacteria detection for biopharmaceutical products before they are sold to consumers, to ensure they are free from the bacteria which could interrupt people’s attempts to get healthier.
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.
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.
Bionique’s ability to grow comes from new developments in both the biopharmaceutical industry and the company itself.
In the past decade, Zamparo said the world has seen the emergence of numerous cell and gene therapies for treating a variety of health conditions ranging from genetic disorders to cancer.
“Today, there are over 1,947 active clinical trials globally,” Zamparo said.
The U.S. Food and Drug Administration has approved a number of these cell and gene therapies recently, 34 in total.
“These numbers really make it the fastest growing segment of the life science industry,” Zamparo said. “Bionique is in a unique position to cater to this industry.”
Bionique’s services play a critical step in the release of these therapies.
“All these therapies need to be screened for mycoplasma,” she said, adding that Bionique’s emphasis on rigorous quality for 30 years allowed them to be at forefront of a rapidly expanding and very regulated industry.
Bionique’s acquisition by the Japanese chemical company Asahi Kasei in 2021 has also provided them with the funding to support this growth. Zamparo said the acquisition has been a “great fit” for Bionique and in the past two years it has become an “integral part” of Asahi Kasei’s bioprocess division, along with its European affiliate ViruSure. She said this has given them a platform to showcase their services to a broader audience, raised Bionique’s global visibility and strengthened their position as a leader in a niche arena.
Its clients include eight of the top 20 global cell and gene companies in terms of 2022 total revenue.
“This year alone, Bionique has delivered services to 35% of the top 20 global cell and gene therapy companies,” Zamparo said.
The planned expansion
The proposed 19,000-square-foot expansion is at Bionique’s existing 9,459 square-foot building on Fay Brook Lane near the Adirondack Regional Airport in Lake Clear. Zamparo said they got approval from the APA on Nov. 28. This project fell under APA jurisdiction because it is more than a 25% expansion of a commercial use in an industrial land use area.
APA spokesman Keith McKeever said the plans got staff approval. Based on the public comment made on the project, staff decided the APA board did not need to take a vote on this project.
Zamparo said construction is expected to start in April and last through the summer of 2025.
She added that she wants to expand Bionique’s services with the new space by getting new equipment to add new biosafety testing services in endotoxins and sterility. Mycoplasma is just of many tests that pharmaceuticals must go through before going to market, and she said their goal is to offer more of these tests than they do currently.
The expansion would also double the parking lot capacity to 100 vehicles.
Hiring
Zamparo said Bionique has reached its goal of having 50 employees by the end of 2023.
The APA application says the lab plans to eventually employ 90 people. Last year, the lab had 43 employees and was looking to hire many more. The lab still has some positions open.
Zamparo said Bionique will be looking to hire a range of people, from entry-level positions to ones with industry experience — lab analysts, scientists, quality assurance personnel, equipment maintenance technicians, administrators and project managers.
But a lack of affordable housing in this region has been making that difficult. Zamparo said Bionique has a number of remote or hybrid positions because of this. She said while rental shortages affects the whole community, Bionique has been trying to find workarounds, offering assistance, advice and opportunities to people moving here to work for them. This is critical to ensure hires, she said.
Even though the jobs offer good pay, some applicants turned down jobs because of the housing barrier and found work elsewhere instead. People who were hired struggled to find housing to move locally.
Zamparo said 90 employees is a long-term goal for Bionique. Their expansion can hold up to 90 people, but they won’t be there right away. Rather, she said they plan to hire more gradually as they start bringing in new services.
She said the company has been working with local colleges to bring in new hires.
“We really value the North Country,” Zamparo said.
‘Demanding field’
Their industry is a highly regulated one, Zamparo said.
“It is a demanding field,” she said.
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.
“We have to ensure that we deliver these services to customers that are waiting for our results to be able to deliver the therapies to patients,” Zamparo said. “There is urgency in what we do.”
She said it takes a lot of energy to make sure they are meeting both the regulatory guidelines and service guidelines.
“This is not a coincidence. It requires a lot of deliberate decision on our part not to sway from our core principals of delivering quality for our customers,” Zamparo said. “I cannot stress enough how critical it is for clients to know that their provider is dependable and delivers quality service on time.”
She said Bionique is not after what is easy or what makes growth fast.
“Even in a fast-growth industry, when it comes to a regulated industry, you cannot afford any fault,” Zamparo said. “You cannot afford to make a mistake. Because your reputation really relies on that ability to deliver over and over and over.”
Founded by Daniel and Judith Lundin in 1990, the company 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. and in August 2020 Bionique expanded again, opening a second location on Main Street by the village’s Saranac River dam.
In the past, Zamparo has said Bionique was growing at a rate between 10% and 20% in the late 2010 and through the start of the coronavirus pandemic. Despite Saranac Lake being a small area in terms of population, she said the expertise and institutional knowledge the company has developed has made it possible for it to be a company on the global scale.
“Being part of a small community makes us stronger because people are invested in the success of the organization,” Zamparo said. “It’s what makes us proud.”
She likes that she sees employees feel invested in the community they live in. Bionique staff recently participated in the Saranac Lake Turkey Trot to raise money for the Saranac Lake Interfaith Food Pantry and Saranac Lake Central School Student Needs Fund supported ADK Unite, and donated toys to the Holiday Helpers toy drive.