Bioassay capability

Our technical expertise spans every stage of your biologics development and manufacturing journey, with bioassay services and capabilities that allow us to confidently advance your product further.

Why are bioassays important?

Bioassays are a crucial aspect of biologics development and manufacturing, ensuring product safety, efficacy and quality. By measuring biological activity, evaluating immunogenicity and determining product characteristics, bioassays can help to support every stage of development and manufacturing.

 

Understanding our bioassay capabilities

We have comprehensive bioassay capabilities that can support every stage of your biologics development and manufacturing, including:

  • Cytotoxicity assays
    • Antibody-dependent cell-mediated cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC) assays
    • Fc-based effector function assays
  • Binding kinetics
    • Fc-based binding kinetics
    • Receptor-ligand binding kinetics
    • Antibody estimation
  • Pharmacokinetics and immunogenicity
    • USP and ICH-compliant assays
  • Cell-based assays
    • Reporter and conventional cell-based assays
  • Flow cytometry
    • Cell analysis
    • Receptor quantification
  • Data analysis
    • USP and ICH-compliant software for data analysis

Why partner with Enzene ?

We are a global Continuously Innovative Development and Manufacturing Organization (CIDMO), dedicated to changing the paradigm by which affordable biologic and biosimilar medicines are brought to market. Since Enzene’s inception, our innovative agility has enabled us to continually introduce transformative processes in biologics manufacturing that significantly increase product yields of complex biologics and monoclonal antibodies (mAbs) while reducing the manufacturing footprint and the cost of production.

Game-changing innovation is only the beginning, though. We are Enzene, and that means that our values of innovation, entrepreneurship, respect, candor, excellence, and integrity underscore everything we do from project management and communications to teamwork and ideation. To us, true partnership is about driving biotech innovation while doing so in a way that develops long-lasting trusted partnerships.

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The future begins now

Your biologic deserves the most technologically advanced manufacturing process in the industry. And you deserve a new way to think about strategic partnership. Today is just the beginning.