About Cygnus
Cygnus Technologies, part of Maravai LifeSciences, provides best-in-class analytical tools and solutions to help 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. As the biopharmaceutical industry’s partner in analytics for host cell proteins (HCP), other process-related impurities, and viral clearance, Cygnus’ off-the-shelf products and custom services ultimately improve bioprocess development for faster regulatory approval and better clinical outcomes.
Founded by Ken Hoffman in 1997, 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; as of July 1, 2024, Cygnus’ off-the shelf and custom assays have been used for lot release testing of multiple licensed novel biologics, biosimilars, and over 20 approved cell and gene therapies. Cygnus 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 offers an innovative approach that utilizes non-infectious mock virus particles through its MockV™ viral clearance prediction kits.
Cygnus’ proprietary technologies, available through its products and custom assays/services, set 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.
25-Year History of Quality and Innovation
1997
Cygnus Technologies is founded with 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
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
2016
Strategic investment by Maravai LifeSciences
2017
HCP ELISA kits introduced for the detection of HeLa and MDCK
2019
Cygnus Technologies attained ISO 9001:2015 Certification
2019
Launched the EndonucleaseGTP® ELISA Kit used in quality control during viral vector and vaccine manufacturing
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.
2022
Launched the MockV RVLP Kits used early in downstream purification development for viral clearance prediction.
2023
Launched the PG13 HCP ELISA Kit used for gene and cell therapies that utilize retroviral packaging.
2024
Developed AccuRes™ Host Cell DNA Quantification Kits to amplify and quantify femtogram levels of residual DNA using compendial methods described in USP Chapter <509> Residual DNA Testing.
2024
Expanded Mix ‘n Go ELISA offerings to include Protein L Kits in addition to Protein A Kit.
2024
24 of 24 Approved gene therapies and genetically modified cell therapies use Cygnus kits for product lot release.
2024
USP Chapter <1132.1> Residual Host Cell Protein Measurement in Biopharmaceuticals by Mass Spectrometry introduces the incorporation of MS techniques as orthogonal methods for HCP analytics
Company Information
Christine was appointed COO for Cygnus Technologies in October 2017. She is accountable for the P&L including all operations, designing/implementing business processes, evolving organizational structures/strategies and progressing the product pipeline 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 global 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, Vice President, Strategic Marketing and Business Development
Alla leads strategic technical 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.
Gary Cross, Vice President of Operations and Process Excellence
Gary was appointed VP in June 2023. He leads the Manufacturing, Order Fulfillment, Customer Service, Facilities and Engineering teams. Gary brings a wealth of Manufacturing Engineering and Operations experience having led manufacturing at multiple facilities. Prior to joining Cygnus, he led and grew global organizations for GE Healthcare, ThermoFisher and Repligen . Gary holds a Masters in Mechanical Engineering specializing in Advanced Manufacturing Technology from Portsmouth University in the UK.