About Cygnus

Cygnus Technologies, part of Maravai LifeSciences, is the biopharmaceutical industry’s partner in host cell protein (HCP) and other process-related impurity detection and analytics. In addition, Cygnus now provides innovative viral clearance solutions as well. 

Cygnus helps companies developing therapeutic proteins, vaccines, antibodies, plasma derivatives and gene therapies to ensure the safety of biotherapeutics prior to human trials, regulatory approval and commercial release. Cygnus provides analytical tools and solutions delivering insights to improve bioprocess development for faster regulatory approval and better clinical outcomes.  

Cygnus is an industry pioneer responsible for developing and commercializing the first generic assay kits for HCP detection. Its reputation for quality is recognized by the industry and global regulatory agencies. It continues to advance the science of bioprocess impurity detection with new breakthroughs, including its Antibody Affinity Extraction™ (AAE) technology and orthogonal methods of HCP analysis that integrate Mass Spectrometry, AAE and ELISA. To reduce the cost and risk associated with viral clearance studies, Cygnus also offers a unique approach that utilizes non-infectious mock virus particles through its MockV™ virus clearance kits.

Cygnus’ proprietary technology, available through its off-the-shelf and custom analytics programs, sets the gold standard for enabling HCP and other bioprocess impurity antibody assays. Cygnus delivers best-in-class customer service and technical expertise, operational excellence and ISO-9001:2015 certified quality management systems.

Founded by Ken Hoffman in 1997, Cygnus continues to support and advance technology in order to improve biotherapeutic safety and accelerate the movement of new therapeutics through the development and regulatory approval process.

Cygnus Headquarters

20-Year History of Quality and Innovation

Origin Cygnus Kits circa 1997

1997

Cygnus Technologies is founded with the publication of a review article demonstrating a novel approach to host cell protein analysis

1999

First generic ELISA kit for analysis of CHO and E. coli host cell proteins from Cygnus Technologies. Kits for a wide range of expression systems were developed in the coming years.

2008

Cygnus Technologies began offering orthogonal services for the identification of individual host cell proteins. These services include 2D western blot and 2D HPLC

2012

Cygnus Technologies introduced kits for host cell DNA extraction and detection

D100T -- DNA Extraction Kit in Tubes
Antibody Affinity Extraction

2014

Introduced a new method – antibody affinity extraction (AAE) – to replace 2D western blot assays.

2016

Cygnus Technologies demonstrated efficacy of integrating orthogonal data from mass spectrometry analysis and AAE

Maravai LifeSciences Logo

2016

Strategic investment by Maravai LifeSciences

2017

HCP ELISA kits introduced for the detection of HeLa and MDCK

F810 HeLa ELISA Kit
Maravai LifeSciences Logo

2019

Cygnus Technologies attained ISO 9001:2015 Certification

2019

Launched the EndonucleaseGTP® ELISA Kit used in quality control during viral vector and vaccine manufacturing

F960 EndonucleaseGTP ELISA Kit
MockV Logo

2020

Maravai LifeSciences acquired MockV Solutions to further strengthen its position in bioprocess impurity analytics with products for viral clearance testing. MockV Solutions has been integrated into Cygnus operations.

Company Information

Year Founded:
1997
Number of Employees:
45+
Facilities:
Headquarters, R&D and manufacturing in Southport, North Carolina, USA.
Key Technology:
Proprietary immunoassays and orthogonal analytical methods for detecting and characterizing impurities in biotherapeutics.
Management:
Ken Hoffman, Founder
Ken Hoffman founded Cygnus Technologies in 1997 to provide analytical solutions to the rapidly growing biopharmaceutical industry and is a thought leader in the field of biotherapeutic impurity analysis. Prior to starting Cygnus, Ken worked in the clinical diagnostics field for a number of companies, including bioMerieux, developing automated systems and extensive menus of assays for infectious disease, metabolic disease, drugs and hormones. Ken holds multiple degrees, including a M.S. in Radiation Biology/Immunology from University of Iowa and a Certificate in Biomedical Research Management from the Harvard School of Public Health.

Christine Dolan, Chief Operating Officer
Christine was appointed COO for Cygnus Technologies in October 2017. She is accountable for all operations including designing / implementing business processes and organizational structures / strategies to ensure continued longevity and growth. Prior to joining Cygnus Technologies, she was the SVP of Product Development at Catalent Pharma Solutions and served in several senior global Quality, Operations and Business Unit leadership roles during her 8 year tenure. In addition, she has held progressive operational management roles at GE Healthcare and Amersham Health. Christine started her career as a Microbiologist, and holds a B.S. in Biology from Lenoir Rhyne College.

Eric Bishop, Vice President of Research and Development
Eric oversees the research and development team at Cygnus Technologies and is responsible for new product development and technical support. Eric joined Cygnus Technologies in 2010, bringing a background in R&D for several biopharmaceutical companies. He holds multiple degrees, including an MBA from Hood College, an M.S. in biotechnology from Johns Hopkins University and a B.S. from Radford University.

Alla Zilberman – Director, Marketing and Business Development
Alla leads strategic marketing and business development at Cygnus Technologies. Alla joined Cygnus Technologies in 2017 bringing 17 years of experience in product management, strategic marketing and technical sales in the bioprocessing and life science industries. Prior to Cygnus Technologies, Alla spent several years at Semba Biosciences leading commercialization of a disruptive continuous chromatography platform for downstream bioprocessing, and at Novagen/EMD Biosciences, where she was responsible for product management and marketing of tools and technologies for protein expression, purification and sample prep for proteomics research. Alla earned a Ph.D. degree in Biochemistry from the First Moscow Medical Institute and an MBA degree from the University of Cincinnati. 

Contacts for the Media:
Christine Dolan
(910) 454-9442 
[email protected]