About Custom Biologics

Where scientific integrity and reliability meet

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

Leadership Team

Photo of Dan Mamelak
Dan Mamelak, Phd
Founder & President
Photo of Kalhari Silva
Kalhari Silva, PhD
Head of Scientific Research & Innovation
Photo of Carolyn Modi
Carolyn Modi
Quality Assurance Manager
Talk to our team

Our Story

2004 Custom Biologics was founded. Provided contract R&D proteomic services and protein characterization using MALDI-MS and ESI-MS
2006 Custom Biologics expanded mass spec services to include small molecule quantification in biological matrices and implemented a GLP compliant quality system based on the FDA's 21 CFR Part 58 Guidelines.
2010Introduced large molecule cell based assay testing services
2015 Purchased 115 Skyway Ave. Major renovation of aging CDMO facility into a new state of the art GLP compliant Bioanalytical Testing laboratory
2024Celebrated 20th anniversary with rebrand and new website launch

Uncompromising quality.
That’s our promise to you.

At Custom Biologics, we pair exceptional scientific integrity with the practical regulatory insights you need to successfully develop and market your drug. Explore our services to find the right option for you.

BiologicsGenomicsDASL-Rapid™Quality Assurance