Residual DNA Testing

Charles River can detect and quantify minute amounts of residual host cell DNA by using three highly sensitive, validated methods. These methods encompass the entire range of residual DNA from nonspecific detection of total DNA to highly specific detection of single target sequences. The methods used are:

  • Threshold Assay - uses DNA binding-proteins with high affinity for single-stranded DNA for nonspecific quantification of total DNA
  • Hybridization Assay - a hybridization-based method for the detection of specific DNA of defined origin
  • qPCR Assay - a quantitative PCR-based method for the detection of specific DNA of defined origin; targets a specific gene sequence for amplification

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Manufacturing

Charles River offers cell bank manufacturing services for both microbial and mammalian cells lines.

Release Testing

Release testing services for bulk drug substances and clinical and marketed products for the European Union (EU), United States (US) and other regulatory-distinct markets.

RightSource

We work with you to evaluate your quality control (QC) testing programs by reviewing your current testing structure and selecting the best-suited and most cost-efficient mix of insourcing and outsourcing options.