Custom Biologics

Custom Biologics is a Canadian contract research organization (CRO) specializing in bioanalytical services for biopharmaceuticals, vaccines, and cell and gene therapy products. With over 20 years of experience, the company focuses on designing and validating regulatory compliant assays for functional characterization, potency/bioactivity assessments, clinical pharmacokinetics, and immunogenicity of biotherapeutic drugs. Custom Biologics' genomics group develops molecular genetic assays for gene and genome analysis, measuring genetic inserts and transgenes in gene therapy vectors, oncolytic viruses, and nucleic acid-based vaccines. The company has also developed a proprietary isothermal nucleic acid amplification technology called DASL-RAPID for rapid identification of human and food-borne pathogens. Custom Biologics maintains a Health Canada cGMP Drug Establishment License and operates under a quality system based on FDA and EMEA GLP guidelines. The company's services are utilized in preclinical research and development programs, as well as for validated GMP-compliant assays suitable for stability analysis, clinical analysis, and clinical/market lot release testing. Custom Biologics employs state-of-the-art bioanalytical laboratory equipment and sophisticated statistical software to generate data for submissions to regulatory agencies worldwide.