Methods and techniques

 

  • Assay automation
  • Assay development and validation
  • Apoptosis testing
  • Appearance
  • Assessment of biological potency
  • Bioburden
  • Biomarker analysis
  • Cell proliferation assays
  • Confirmatory DNA sequencing
  • Cryosection
  • Cytofluorometry
  • Cytometric bead array
  • Cytotoxicity testing
  • Determination of copy number
  • Determination of insertion number
  • DNA and RNA preparation
  • DNA/RNA gel electrophoresis
  • ELISA
  • ELISPOT
  • Endotoxin determination
  • FACS cell surface and intracellular antigens
  • FACS endpoints
  • FPLC
  • Gas chromatography
  • Genetic stability testing
  • Host cell protein contaminants: ELISA
  • Host cell residual DNA quantitation
  • HPLC
  • Immunotoxicity
  • Immunohistochemistry
  • Immunofluorescence
  • LC/MS/MS 
  • Leukocyte function
  • Leukocyte phenotyping
  • Ligand binding assays
  • Lot release testing
  • Mutagenicity
  • Northern and Southern blot analysis
  • Osmolality
  • pH
  • Pharmacodynamics
  • Pharmacokinetics
  • Quantitative PCR and quantitative RT-PCR
  • Reporter gene assays
  • Restriction analysis
  • SDS PAGE
  • Stability trials
  • Sterility testing
  • UV/VIS spectrophotometry
  • Western blotting