Increase your confidence in the purity and safety test results in biotherapeutic manufacturing workflows. When safety is paramount and ensuring regulatory compliance is non-negotiable, genetic analysis of product functionality and purity based on sequencing and fragment analysis can help to mitigate risk and accelerate lot disposition.
Production quality control
Expand opportunities for advancements in quality control with genetic studies on microbial and residual vector impurities and unintended cell line proliferation.
Genotypic sequence drift
Explore changing frequencies of genetic variants in your cultured and stored cells and tissues to identify potential genes associated with resistance to your biopharmaceutical.
Targeted locus screening
Track and characterize changing frequencies in biomarkers associated with responses to your biopharmaceutical.
Resources
White Paper: QC for ex vivo manipulated cell lines and tissues
A variety of genetic analysis methods are valuable in ensuring that ex vivo human cells to be used for cell-based therapies are correctly identified, have the correct characteristics, and are free of contaminants.
Related pages
QualTrak digital experience
Discover QualTrak qPCR and dPCR worfklows for mAbs, vaccines, and cell and gene therapies across biopharmaceutical development and manufacturing.
Monoclonal antibody development
Efficiently develop and characterize recombinant monoclonal antibodies (mAbs) from discovery through clinical trials and manufacturing by incorporating genetic-level analysis into your workflows.
Innovative support and instrument expertise
We support you with exceptional services, remote tools, training, and OEM expertise we’ve spent 40 years curating.
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