Search Results for: 's antibodies process related impurity hcp immunoassays'

  • Host cell proteins (HCP) constitute a major group of process-related impurities of biological drugs produced using cell culture technology. HCPs are produced inadvertently during expression of recombinant biopharmaceuticals as secreted from host cells, from aberrant cellular trafficking due to cell stress, and due to cell lysis over the course of bioprocess manufacturing. More than 70% of biological drug substance are produced using CHO cells [1], but Escherichia coli , Pichia pastoris, and HEK ...
  • Cygnus Technologies products are used in the development and manufacturing of all types of biological drugs. These include monoclonal antibodies (mAbs) and recombinant proteins. The FDA began approving therapeutic monoclonal antibodies (mAbs) in 1986. Since then 79 therapeutic mAbs have been approved by FDA and are currently on the market [1].  Around the world, at least 570 therapeutic mAbs have been studied in clinical trials by commercial companies [2]. Uses for monoclonal antibodies include: ...
  • 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 rel...

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