Custom Biologics is Canada’s leading large molecule CRO providing custom bioassay design, validation and regulatory compliant testing.

For over 10 years Custom Biologics has been designing, validating and implementing bioanalytical, ligand-binding, residual contamination and cell-based bioassays to support pre-clinical and clinical testing requirements of large and small molecules. We have extensive expertise in characterizing the functional properties of biologics, in particular biosimilars, as per ICH Q6B guidelines. A list of some of the biosimilars and supporting assays we are experienced with can be found here, http://custombiologics.com/biologics/biosimilars/

All work adheres to an exacting Quality Control System based on FDA 21 CFR, Parts 11 and 58 Guidelines.