Clinical Trial Laboratory Services

Clinical trials for biological products may require additional tests beyond the standard clinical chemistry and hematology. Many of these analyses involve the development of specialized assays that are not routinely performed by most Clinical Research Organizations or Reference Labs. To complement our significant experience in the testing of biological therapeutics, SAFC, through its BioReliance business, offers these assays as part of its Clinical Trial Laboratory Services. All assays are performed according to the principles of GLP.  

BioReliance Clinical Trial Laboratory Services

  • Vaccine Response Assays
  • Detection of viral vaccine neutralizing antibodies
  • Detection of total and neutralizing anti-vector antibodies
  • Detection of vector infectivity
  • Detection of viral vectors by Quantitative PCR and RT-PCR
  • Detection of expressed recombinant protein
  • Detection of cytokine and other biomarker response
  • Genomic Assays
  • Immunogenicity Assays
  • HACA
  • HAMA
  • pK
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