AAIPharma offers a broad range of biopharmaceutical analytical services to support the growing number of biotechnology-derived therapeutic agents. Our scientists are equipped with the technology to support a wide variety of biopharmaceutical products, including proteins, antibodies, antibody drug conjugates (ADC) nucleic acids (DNA, RNA or oligonucleotides), and biologics.

Our biopharmaceutical services include:

  • Method development and validation for Biopharmaceutical Active Pharmaceutical Ingredient (API) and Finished Product
    • Potency
    • Purity
    • BioActivity
    • Biosafety
  •  Biopharmaceutical structural characterization
    • Amino Acid Analysis (AAA)
    • Peptide Mapping
    • N-terminal Sequencing by Edman Sequence and LC/MS
    • Molecular Weight Determination
    • Glycan Analysis
    • Oligosaccharide Analysis
    • Extinction Coefficient Determination
    • Accurate Mass Determination
  • Host cell residual Protein and residual DNA residue testing
    • Real-Time Polymerase Chain Reaction (PCR)
    • Threshold Technique
  •  Purity Assessment by Electrophoresis
    • Imaging Capillary Isoelectric Focusing (iCE)
    • SDS-PAGE
    • Isoelectric Focusing
    • Western Blot
    • Capillary Electrophoresis with IEF
  •  Bioactivity testing
    • ELISA, with detection by absorbance, chemiluminescence, or fluorescence.
    • Cell-based assay development and validations
  • Aggregation, particulates and agglomerate analysis
    • Microfluid imaging
    • Size-Exclusion with Multi-Angle Laser Light Scattering (MALS)
    • Dynamic Light Scattering
  •  Quantitative and accurate mass spectrometry
    • Triple-Quad LC/MS
    • QTOF