Custom Biologics is Canada’s leading large molecule CRO providing custom bioassay design, validation and regulatory compliant testing.
Our Bioassay Group develops and validates custom assays to evaluate the therapeutic potential of biological macromolecules. Our bioassays are developed using the latest technologies and employed for all phases of drug development, as well as GMP-lot release testing of biologics destined for the clinic.
All assays are designed to meet the latest regulatory guidelines of ICH Q6B, USP <1032>, <1033> and <1034>.
Custom Biologics maintains a controlled storage facility that can accommodate sample and reagent storage at 2-8°C, -40°C, -80°C, and under liquid nitrogen conditions.
Custom Biologics is a regulatory compliant testing facility with a Quality System based of FDA Guidelines 21 CFR Parts 11, 58 and 211.
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