Testing in Monoclonal Antibody Manufacture

In addition to standard testing of custom monoclonal antibodies and their hybridomas, we offer a variety of additional screening and assay testing service options to validate monoclonal antibodies for use in specific applications, including release and stability assays for use in animal or human. We conduct all of these assays under GLP.

Currently available testing procedures at Antibody Solutions include:

  • Concentration
  • Purity
  • Monodispersity (Analytical SEC)
  • Isoelectric Focusing Mobility
  • Isotype
  • Affnity & Binding Kinetics (KD, kon, koff)
  • Endotoxin
  • Bioburden
  • Sterility
  • DNA
  • DNAse & RNAse
  • AA Sequence
  • Functional Activity (ELISA, Flow Cytometry, Western Blot, etc.)
  • Conjugation Ratio (for conjugates)
 
testing

Isoelectric Focusing Gel
For lot-to-lot quality control, we recommend isoelectric focusing (IEF). IEF identifies the unique isoelectric point (pI) and banding pattern for each lot of an antibody

 
testing (graph)