Discover why Custom Biologics is your trusted partner — at every stage of the drug development journey
For over 20 years, Custom Biologics has been designing and validating regulatory compliant assays to support the functional characterization, potency/bioactivity assessments, clinical pharmacokinetics, and immunogenicity of biotherapeutic drugs, vaccines and cell and gene therapy products.
Our genomics Group designs and validates sophisticated molecular genetic assays to conduct gene and genome analysis and to measure levels of genetic inserts and transgenes in gene therapy vectors, oncolytic viruses, and nucleic acid-based vaccines. The activity of these trans gene products can be measured in vitro and in a multitude of biological matrices and tissues. A novel and proprietary isothermal nucleic acid amplification technology (DASL-RAPID) has been developed in our laboratories to rapidly identify human and food borne pathogens.
Our scientists and quality assurance unit work closely with the scientific and regulatory teams of biopharmaceutical drug companies around the globe. Our attention to scientific detail and thorough documentation guarantees that the data we generate are suitable for regulatory submission worldwide. A collaborative environment provides the workspace for our research groups to share ideas, troubleshoot and constantly expand our technical know-how to meet the evolving specialized testing needs of our clients.
Custom Biologics maintains a Health Canada cGMP Drug Establishment License and is governed by a rigorous quality system based on the FDA’s and EMEA’s GLP guidelines.
Great science is at the heart of everything we do!
20+ Years of Industry Experience
200+ Pre-Clinical/CMC and Clinical Immunogenicity Studies
125+ 125 World Wide Clients