At Cytovance® Biologics Analytical Development Laboratory, we have the expertise to develop analytical methodologies and design testing plans to meet your individual product needs.  

Our experienced scientists will guide your method development, optimization strategies, and specialize in creating product specific methods to measure process-related performance. In addition to developing product specific methods, our staff has extensive experience in transferring and optimizing methods developed at any stage and preparing standard operating procedures which have the performance to be used in a quality control laboratory. Cytovance® also offers several platform method technologies which we can evaluate as appropriate methods for your product, this can decrease method development time and help drive more cost-effective analyses. 

The method development team coordinates with Process Development to provide analytical support, data interpretation to help guide the development of critical quality attributes throughout the development process. 

We also offer phase appropriate method qualification and validation services. 

Our Capabilities include:

  • Visual Appearance
  • Osmolality
  • pH
  • Conductivity

  • Antibiotics
  • Residual Protein A
  • Residual Host Cell Proteins (CHO, E.coli, Pichia, Pseudomonas)
  • Residual Host Cell DNA (CHO, E.coli)
  • Insulin
  • Tween
  • Cyanide
  • Unbound PEG

  • ForteBio Octet (Protein-Protein Interaction)
  • Antigen Binding ELISA
  • Cell Based Potency (Bioassays)
  • Enzyme Kinetic Assays (Activity, Km, Kcat)

  • Peptide Mapping (LC-UV/VIS Fingerprint Analysis)
  • N-Linked Glycan Mapping
  • Monosaccharide Quantitation
  • Sialic Acid Determination
  • Iso-Electric Focusing

  • CE-SDS
  • Iso-electric Focusing (IEF) (Vertical or Slab)
  • cIEF (Capillary)
  • icIEF (Imaged Capillary)
  • Western Blot

  • Quantitation
  • Impurities
  • Process Residuals

  • UV/VIS Spectroscopy (A280 nm)
  • Bicinchoninic Acid (BCA) Assay
  • Bradford Protein Assay
  • HPLC

  • Size Exclusion/Gel Filtration (SE-HPLC)
  • Reverse Phase (RP-HPLC)
  • Ion Exchange (CEX/AEX)
  • Hydrophobic/Hydrophilic Interaction
  • Affinity Chromatography
  • Detectors Available:
    • Dual Wavelenghth (UV/VIS)
    • Photodiode Array
    • Fluorescence Detection
    • High Pulsed Amperometric Electrochemical Detection (HPAED)
    • Multi-Angled Light Scattering (MALS)
  • PEG Anlaysis