Custom Biologics

Custom Biologics

Custom Biologics is a regulatory compliant large molecule bioanalytical CRO that provides CMC and clinical testing services for all phases of biotherapeutic drug development and manufacturing. Our biologics division designs and validates highly specialized ligand-binding and cell-based potency bioassays to support the functional characterization, activity assessment, pharmacokinetics, immunogenicity and clinical testing requirements of biologic, oncolytic virus, vaccine, and gene therapy drug candidates. Our genomics division develops sensitive and rapid nucleic acid tests. Custom Biologics maintains a Health Canada cGMP Drug Establishment License.

Bioanalytical Services, Biomarkers, Biotechnology Research/Testing, CRO—Contract Research Organization, Cancer Biology/Carcinogenicity, Cells/Tissue, GLP—Good Laboratory Practice Services, Immunology Research/Testing, Nonclinical Research, Pharmacokinetics, Preclinical Research/Testing