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cygnustechnologies

cygnustechnologies


Cygnus technologies, Inc.是美国一家专门从事生物工程和制药过程中残留物检测的一系列产品。生物制品生产过程中存在许多影响产品质量的残留物,诸如特殊重组表达系统中宿主细胞蛋白( Host Cell protein, HCP )的残留以及生物制品加工过程中培养物残留的污染物。 其产品主要包括: * 检测宿主细胞蛋白残留和生物制品生产过程污染物(Elisa 试剂盒); * 检测并鉴定常用重组表达系统中的宿主细胞蛋白(WesternBlotting 试剂盒) * 为生物医药行业提供检测生物制品免疫原性的方法; * 检测微生物的抗体


美国一家专门从事生物工程和制药过程中残留物检测的一系列产品。生物制品生产过程中存在许多影响产品质量的残留物,诸如特殊重组表达系统中宿主细胞蛋白( Host Cell protein, HCP )的残留以及生物制品加工过程中培养物残留的污染物。


About Cygnus


Cygnus Technologies is the leading provider of assays and services for the detection and characterization of impurities, such as host cell proteins, in biopharmaceuticals. Building on innovative, proprietary technology, the company develops highly specialized analytical products that meet the unique needs of the pharmaceutical, vaccine, gene therapy, and biotechnology industries.


Impurity analysis is an important step in biotherapeutic regulatory approval and quality control processes. With kits, immunoassay reagents, orthogonal analysis services, and expert advice, Cygnus Technologies helps biopharmaceutical companies accelerate the movement of new therapeutics through the development and approval stages to market. Cygnus Technologies also offers outsourcing capabilities, using highly specialized technologies to develop custom, target-specific antibodies and assays. A privately held company, Cygnus Technologies was acquired by Maravai LifeSciences in 2016.


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:30+ 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. David Weber, Vice President and Chief Commercial Officer David comes to Maravai LifeSciences with over 35 years of experience in life sciences industry commercial leadership and general management. David is responsible for all marketing, sales, product development, commercial strategy, service, and support for all Maravai LifeSciences portfolio companies. Prior to joining Maravai LifeSciences, David served as Executive Vice President and Chief Commercial Officer for Affymetrix leading up to its acquisition by Thermo Fisher Scientific. Earlier in his career, David held a variety of commercial leadership roles in life science companies including Amersham Biosciences (GE Healthcare), Eksigent Technologies, Cyntellect, Stratagene, and The Linus Group. Harjit Kullar, Vice President of Marketing Harjit comes to Maravai LifeSciences with over 15 years of experience in sales and marketing in the life sciences and diagnostics industries, most recently holding the position of Vice President of Marketing at Transgenomic. Earlier in his career, Harjit held a variety of commercial leadership roles in life science companies including Bio-Rad Laboratories, Thermo Fisher Scientific, Life Technologies, LifeSpan BioSciences and Abcam. Harjit received a BSc in Biochemistry & Pharmacology from University of Southampton, a Ph.D. in Cancer Biology from University of Birmingham and an MBA from University of Cambridge.

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