About Custom Biologics
Custom Biologics™ has a proven track record spanning more than 10 years for developing, validating and implementing GLP-compliant bioanalytical, ligand-binding and cell-based bioassays to support the characterization, activity assessment, pharmacokinetics and clinical testing requirements of large and small molecules, biomarkers and drug candidates.
An exacting Quality Control System, managed by an independent QA unit, ensures that all work performed at Custom Biologics™ adheres to rigorous quality control procedures based on FDA 21 CFR, Part 58 and Part 11 Guidelines.
We are committed to remaining at the forefront of industry practices for Chemistry, Manufacturing and Control (CMC) laboratory services by continuously developing new assays and by adopting the latest laboratory technologies compliant with evolving regulatory guidelines.
We have highly qualified industrial scientists with strong ‘can-do’ attitudes on our team who are quick to engage with our clients’ innovative drug development programs. We have been privileged to work with small to large multinational biotech and pharmaceutical companies across North America and Europe.
In May 2015 we moved into a new 8,000 square foot secure GLP-compliant facility specifically designed to accommodate our broad scientific capabilities and further growth.
We have a distinguished record of commitment to our clients and a reputation for fulfilling all testing requirements within budget and in a timely manner.