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Safety On The Cellular Level

By Johanna Cano, posted Jun 17, 2022
Cygnus Technology, which provides purity testing of biotherapeutics, is described as a leader in developing and manufacturing testing kits for the pharma and biotech industry. (Photo c/o Cygnus Technologies)
The origin of Cygnus Technologies, a company that provides analytical products to the pharmaceutical and biotechnology industry, can be traced to the founder’s motto of creating value.
 
The Southport-headquartered company was established in 1997 by Ken Hoffman in Boston when he found an unmet need in the growing biopharma industry in biologic testing for purity, said Cygnus chief operating officer Christine Dolan.
 
“At that time, many companies started to expand their drug development pipelines from small molecule drugs that were typically made by chemical synthesis to biological drugs that were made using cell culture technology processes,” Dolan said.
 
This shift meant companies that were developing biological-based drugs needed safety testing and Cygnus specializes in testing for host cell proteins or HCPs, which can interfere with drug efficacy even at extremely low levels.
 
Cygnus was founded with the publication of a review article that demonstrated a new approach to host cell protein analysis. In the scientific paper, Hoffman discussed the evolution he saw in testing for impurities to enable development of safe biological drugs and to reduce cost and time.
 
Before founding Cygnus, Hoffman worked for several companies in the clinical diagnostics field and has a master’s degree in radiation biology and immunology from the University of Iowa and a certificate in biomedical research management from the Harvard T.H. Chan School of Public Health.
 
As Hoffman’s company grew, he realized he need to expand and move operations to a stand-alone location, so in 2002 he relocated Cygnus to Southport, drawn by the weather, beaches and year-round golf.
 
Today, Cygnus is described as a partner in the biopharmaceutical industry, helping companies that are developing therapeutic proteins, vaccines, antibodies, plasma derivatives and gene therapies to ensure the safety of biotherapeutics (drug products using living cells) prior to human trials, regulatory approval and commercial release.
 
According to its website, the company is a pioneer in developing and commercializing the first generic assay kits for host cell protein detection in 1999. Cygnus continued to develop kits with the manufacturing, assembling and distribution of kits for a wide range of expression systems over the years.
 
“Cygnus kits are widely considered to be the industry gold standard globally,” Dolan said.
 
In 2016 Cygnus was recognized as an industry leader when it was acquired by Maravai LifeSciences, a life science research market company that describes Cygnus as having “effectively created the biotherapeutics impurity testing field as the pioneer in analytical test kits and ongoing development of related products and services.”
 
David Weber, vice president and chief medical officer for Maravai LifeSciences, a publicly traded company, said at the time that the company had outstanding growth possibilities.
 
In the past two decades, the company has moved and expanded its location several times, from a 2,000-square-foot facility in 2010 to its current 22,000-square-foot facility.
 
Now, the company will be doubling its space with a move to Leland, announced last year. The 45,000-square-foot facility at Waterford Commercial Park is under development by Wilmington-based CIGG LLC, which at the time of the announcement said it was investing more than $10 million.
 
“We chose Leland for a couple of reasons: first, we needed a green field space in order to design and build a state-of-the-art facility to accommodate our new specialized offerings such as mass spectrometry and MockV viral clearance prediction, as well as provide customized high-capacity cold storage for our products,” Dolan said.
 
Mass spectrometry, an analytical technique used to measure the mass-to-charge ratio of molecules present in a sample, was introduced as a service by Cygnus in 2019. In 2020, Maravai acquired MockV, with a novel viral clearance prediction technology which was integrated into Cygnus’ operations.
 
The company also chose Leland for its centralized location for its employees, especially for those currently commuting from Wilmington to Southport.
 
Cygnus currently has 50 employees, and the new facility would allow for up to 150 employees who would be hired over the next few years, according to a press release.
 
The company anticipates occupying the new facility by the end of the year and has worked with developers to design a layout that includes lab space, manufacturing areas, cold storage, office and conditioned warehouse.
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