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

Event
August 27, 2025
Gene Therapy Challenges & Best Practices: From Discovery to IND & Beyond (PBSS 2025)
Join us at the PBSS 2025 event in Foster City on September 26, where industry leaders will discuss gene therapy innovations. Visit Custom Biologics to learn about our advanced bioanalytical solutions supporting gene therapy programs from discovery through clinical trials. Connect with us to optimize your development strategies.
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!

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