Exceptional Science.
Uncompromising Quality.

Your regulatory compliant large molecule bioanalytical CRO

Custom Biologics is a global leader providing specialized, GLP-compliant, assay development, validation and testing services to support the pre-clinical/CMC and clinical stages of biopharmaceutical drug development.

Latest Resources

Article
August 7, 2025
AAV Potency Assays in Preclinical CMC: Key to Successful Gene Therapy Development
Learn why early AAV potency assay development is key to smooth tech transfer, regulatory success, and phase-appropriate CMC strategies in gene therapy.
Event
May 12, 2025
BIO International Convention 2025
Join Custom Biologics at the BIO International Convention 2025 in Boston from June 16-19. Visit us at booth #2482 and discuss your bioanalytical needs in cell and gene therapies, vaccines, and more. Schedule a meeting today!
Event
April 16, 2025
AAPS National Biotechnology Conference 2025
Join Custom Biologics at the AAPS National Biotechnology Conference 2025 in Boston from May 4-7. Discover advancements in gene editing, personalized medicine, and sustainable biomanufacturing. Visit us at booth #406 to explore innovative bioanalytical solutions for complex biologics and more. Connect with us to enhance your drug development strategies!

Ready for the next stage of your drug development journey? Let’s plan next steps together.

Whether you have a specific project you’d like to discuss, or have a question about our suite of biopharmaceutical assays, we look forward to hearing from you.

Contact us today