Bioprocessing - Titer & Impurity Testing

  • Screen samples during cell line development
  • Monitor titer production from bioreactors
  • Determine dynamic binding capacity of affinity resins on packed chromatographic columns and characterize the purified product
  • Quickly detect and monitor potential process generated contaminants such as Host Cell Proteins and residual protein A with better precision and robustness than traditional ELISAs

Efficiency in process development of biologics

Overview for Bioprocessing - Titer & Impurity Testing

The desire to minimize costs for the production of biopharmaceutical drugs while maintaining high standards of quality and safety means that companies are constantly in search of technologies that can simplify the drug development workflow and reduce the time to results. From upstream processes such as cell line development to downstream processes like purification columns dynamic binding capacity assessment, product contaminant testing, titer, etc, analytical techniques that enhance efficiencies while maintaining quality are critical to the development of biopharmaceutical drugs.

  • Titer and protein quantitation on the Octet system

    Octet systems are a suitable replacements for ELISA and HPLC techniques in the quantitation of antibodies and recombinant therapeutic proteins. They are high throughput, accurate, fast, and are easy to use allowing for easy development and transfer of methods to QC and manufacturing.

    • Analyze a full plate (96-samples) of IgG titer in as little as two minutes
    • Sample plate format allows for the use of crude and non-purified samples
    • Automation capable Octet HTX and Red 384 allow for walkaway high throughput analysis
    • Readily accommodates the use of DOEs to rapidly develop robust potency measurement methods

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    Impurity testing – Host Cell Protein (HCP) detection on the Octet system

    Host Cell Proteins (HCPs) are contaminants found in biopharmaceuticals expressed in bacterial, yeast or mammalian production cell lines that may copurify with the drug product during purification and that can carry substantial risk of decreasing efficacy of the drug. In addition, they could cause adverse immunogenic reactions in patients making their detection crucial.

    ForteBio and Cygnus Technologies have jointly developed the Anti-CHO HCP Detection Kit for quantitation of residual HCPs. The Octetsystem's rapid high throughput protein analysis combined with the broad HCP recognition and sensitivity of the industry-standard Cygnus 3G anti-CHO HCP antibody bring scientists the best of both worlds for HCP analysis.

    • Complete hands-off, walkaway HCP analysis
    • Fully analyzed HCP results for 96 samples in one hour
    • High precision assays with 5-10% CVs
    • Detection sensitivity as low as 0,5 ng/mL

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  • Impurity testing - Residual Protein A (RPA) detection on the Octet system

    The Ready BLI Detection Kit - Residual Protein A (RPA) applies the principles of BLI to enable sensitive, accurate quantitation of leached Protein A in bioprocess samples while maintaining a simple workflow. The kit utilizes a validated sample treatment method for dissociating Protein A from antibodies that does not require boiling, neutralization, or centrifugation steps.

    • Designed to detect recombinant Protein A constructs and MabSelect SuRe™
    • Accurate quantitation down to 100 pg/mL recombinant Protein A
    • Automated detection with minimal hands-on time
    • Analyze 96 samples in under two hours on the Octet HTX system
    • Optimized and validated assay

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Resources for Bioprocessing - Titer & Impurity Testing

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