Biologics Analytics & Bioassays - Abzena

Cell Line Characterization

The safety and quality of your biologic product starts with the right cell line, discover our GMP-compliant cell line characterization methods.

Cell line characterization is crucial to the control of biologic manufacturing. We offer a broad range of services to characterize your mammalian cell banks in accordance with regulatory guidelines. Our cell line characterization services comply with global standards and are performed in our state-of-the-art facilities where quality excellence is first.

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At Abzena, clones are selected based on productivity and its performance in the bioreactors including product quality assessments that are tailored to your needs. Our standard product quality testing includes sterility, mycoplasma, cell identity, gene sequences, and stability.

We support the comprehensive testing and release of cell banks for GMP manufacturing with expertise in:

  • Research Cell Banking (RCB)
  • Master Cell Banking (MCB)
  • Working Cell Banking (WCB)
  • End of Production Cell Banking (EPCB)

Integrated Cell Line Characterization & Banking

Streamline your biologics development program with our GMP-compliant cell line characterization approach. Backed by regulatory expertise, our experts can help you develop a regulatory-compliant cell line characterization strategy using validated analytical methods. Our customers benefit from our efficient, integrated approach and robust cell banking services.

We perform cell line characterization for Research Cell Banks (RCBs), Master Cell Banks (MCBs), Working Cell Banks (WCBs),and End-of-Production Cell Banks (EPCBs).

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Cell Line Development

AbZelectPRO™ is our cell line development solution which can rapidly progress therapeutic protein & recombinant vaccine programs from DNA to RCB in 10 weeks.

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Research Cell Banking (RCB)

From transfection pools or non-clonal cell lines we apply our robust single cell cloning process to rapidly isolate and identify the most productive monoclonal populations.

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Master Cell Banking

We offer Master Cell Banking (MCB) services to you by way of expanded and customizable cell-line suites derived from your MCB.

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