--- title: Bioanalysis and Biomarkers description: Get bioanalytical data you can trust. Across all phases of development. Select biomarkers that stay reliable through non-clinical and clinical studies. --- ![Logo\_CBS-横版-原色(RGB)](https://www.crystalbiosolutions.com/hs-fs/hubfs/Logo_CBS-%E6%A8%AA%E7%89%88-%E5%8E%9F%E8%89%B2(RGB)-2.png?width=330&height=150&name=Logo_CBS-%E6%A8%AA%E7%89%88-%E5%8E%9F%E8%89%B2(RGB)-2.png) - [Bioanalysis & Biomarkers](https://www.crystalbiosolutions.com/services/bioanalysis-and-biomarkers) - [Characterization & CMC Analytical](https://www.crystalbiosolutions.com/characterization-cmc-analytical) - [Clinical Pharmacology](https://www.crystalbiosolutions.com/services/clinical-pharmacology) - [Regulatory Affairs](https://www.crystalbiosolutions.com/services/regulatory-affairs-biologics-adc-cgt) - [Clinical Support](https://www.crystalbiosolutions.com/clinical-research-services) - [Resources](https://www.crystalbiosolutions.com/news-and-events) - [About Us](https://www.crystalbiosolutions.com/about-us) - [Contact Us](https://www.crystalbiosolutions.com/contact-us) ![experts in biologics-3](https://www.crystalbiosolutions.com/hubfs/experts%20in%20biologics-3.svg) # Bioanalysis and Biomarkers We integrate bioanalysis, immunogenicity, and advanced analytical technologies to help teams: **• Build and validate assays** for biologics, oligos and ADCs **• Measure functional immune responses** using NAb and ADA assay and immunophenotyping. **• Quantify complex analytes** beyond ligand-binding assays **• Track biodistribution, and gene expression** for gene and cell therapy programs **• Select relevant biomarkers** based on immunological and analytical data [![Let's talk](https://hubspot-no-cache-eu1-prod.s3.amazonaws.com/cta/default/146565877/interactive-264126601418.png)](https://www.crystalbiosolutions.com/hs/cta/wi/redirect?encryptedPayload=AVxigLIK0%2FAlUysIabFqc40Weh1OctIpGX%2BUhno32uPHc7ZKe%2F8rNnvaxHzRb%2FOBw9wsZJ4BQq5qMD1Gzep2M6ilvf%2FceaoJjOmh3uuAUnK4B3fxa40Cb486EU0%2B%2FGCM1uS05B0zFKSZawMzPst8DnuNTfkH9okGThLhznuDgKuBxt55Bk5R42LtZ0NcItoZ%2FVIejRh6XHCnYEbPd6E9NG%2B%2FNrn02X5v&webInteractiveContentId=264126601418&portalId=146565877&hsLang=en) ![CBS orange-blue banner-1](https://www.crystalbiosolutions.com/hs-fs/hubfs/website-assets/CBS%20orange-blue%20banner-1.jpg?width=2000&height=21&name=CBS%20orange-blue%20banner-1.jpg "CBS orange-blue banner-1") Global Clients Completed projects Platform Methods Instruments ![Three charts summarizing Crystal Bio Solutions experience: a donut of therapeutic indications with oncology as the largest share, a bar chart of modalities led by small molecules and ADCs, and a bar chart of project experience spanning preclinical through IND, clinical phases, and NDA or BLA.](https://www.crystalbiosolutions.com/hs-fs/hubfs/website-assets/cbs-home-expertise-statistics-indications-modalities-project-experience-charts.png?width=2000&height=914&name=cbs-home-expertise-statistics-indications-modalities-project-experience-charts.png "Three charts summarizing Crystal Bio Solutions experience: a donut of therapeutic indications with oncology as the largest share, a bar chart of modalities led by small molecules and ADCs, and a bar chart of project experience spanning preclinical through IND, clinical phases, and NDA or BLA.") # All-around support ![Logo\_CBS-横版-原色(RGB)](https://www.crystalbiosolutions.com/hs-fs/hubfs/Logo_CBS-%E6%A8%AA%E7%89%88-%E5%8E%9F%E8%89%B2(RGB)-2.png?width=330&height=150&name=Logo_CBS-%E6%A8%AA%E7%89%88-%E5%8E%9F%E8%89%B2(RGB)-2.png) - [Bioanalysis & Biomarkers](https://www.crystalbiosolutions.com/services/bioanalysis-and-biomarkers) - [Characterization & CMC Analytical](https://www.crystalbiosolutions.com/characterization-cmc-analytical) - [Clinical Pharmacology](https://www.crystalbiosolutions.com/services/clinical-pharmacology) - [Regulatory Affairs](https://www.crystalbiosolutions.com/services/regulatory-affairs-biologics-adc-cgt) - [Clinical Support](https://www.crystalbiosolutions.com/clinical-research-services) - [Resources](https://www.crystalbiosolutions.com/news-and-events) - [About Us](https://www.crystalbiosolutions.com/about-us) - [Contact Us](https://www.crystalbiosolutions.com/contact-us) ![Scientist using a multichannel pipette to dispense samples into a 96 well microplate in a GLP bioanalytical lab, representing immunogenicity, PK, and biomarker assay workflows at Crystal Bio Solutions.](https://www.crystalbiosolutions.com/hs-fs/hubfs/website-assets/cbs-home-bioanalysis-biomarkers-multichannel-pipette-96well-plate.webp?width=400&height=300&name=cbs-home-bioanalysis-biomarkers-multichannel-pipette-96well-plate.webp) Bioanalysis & Biomarkers Design, develop and validate custom assays to be regulatory-ready from day 1 ![Rack of purple cap blood collection tubes staged in an analyzer bay, signaling PK and TK sample processing and biometrics workflows that support clinical pharmacology decisions at Crystal Bio Solutions.](https://www.crystalbiosolutions.com/hs-fs/hubfs/website-assets/cbs-home-clinical-pharmacology-blood-sample-tubes-rack.jpg?width=400&height=300&name=cbs-home-clinical-pharmacology-blood-sample-tubes-rack.jpg) Clinical Pharmacology Modelling and success prediction of your drug, translation to humans and dosing. ![cbs-home-cmc-analytical-lab-instruments](https://www.crystalbiosolutions.com/hs-fs/hubfs/website-assets/cbs-home-cmc-analytical-lab-instruments.jpg?width=400&height=300&name=cbs-home-cmc-analytical-lab-instruments.jpg) Chemical Manufacturing Control Full molecule characterization and production at large scale. ![Two scientists in lab coats and safety glasses review data on a tablet in a lab setting, representing regulatory strategy, authoring, and submission support for IND, CTA, BLA, and MAA.](https://www.crystalbiosolutions.com/hs-fs/hubfs/website-assets/cbs-home-regulatory-affairs-experts-tablet-review.jpg?width=400&height=300&name=cbs-home-regulatory-affairs-experts-tablet-review.jpg) Regulatory Guidance and documentation for FDA submissions (IND, BLA, ICH). ## Have a Question? Connect with our experts and get started on your project today. [![Free Consultation](https://hubspot-no-cache-eu1-prod.s3.amazonaws.com/cta/default/146565877/interactive-270508115133.png)](https://www.crystalbiosolutions.com/hs/cta/wi/redirect?encryptedPayload=AVxigLKvq0qhKGQeXAx%2FJXIwnrSaGaAnfDl88NIuGdGn3lTShmAUzynOmUuMiduEv%2FqQnBBoBg%2FIuSMSWKltJdd7w4PSIM%2F7Z9Mead0q%2B%2Fr4U5RtY502%2FGSrpqpHs5y%2FxveeHR%2FCkReBQ%2B%2Fr8AS%2B2jyk1v4u%2BxxI6hZ4bxBkXUP3iiXWrRsK44PRiqy4KhmuMBpfQlX%2Bo5RSgP5LjNRrMrupOV7d2fRF&webInteractiveContentId=270508115133&portalId=146565877&hsLang=en) ![Logo\_CBS-竖版-反白](https://www.crystalbiosolutions.com/hubfs/Logo_CBS-%E7%AB%96%E7%89%88-%E5%8F%8D%E7%99%BD.png) - [Our Services](https://www.crystalbiosolutions.com) - [Bioanalysis and Biomarker](https://www.crystalbiosolutions.com/services/bioanalysis-and-biomarkers) - [CMC Analytical](https://www.crystalbiosolutions.com/characterization-cmc-analytical) - [Clinical Pharmacology](https://www.crystalbiosolutions.com/services/clinical-pharmacology) - [Regulatory Affairs](https://www.crystalbiosolutions.com/services/regulatory-affairs-biologics-adc-cgt) - [Clinical Support](https://www.crystalbiosolutions.com/clinical-research-services) - [Information](https://www.crystalbiosolutions.com/news-and-events) - [Resources](https://www.crystalbiosolutions.com/news-and-events) - [News & Events](https://www.crystalbiosolutions.com/news-and-events) - [Careers](https://www.crystalbiosolutions.com/careers-at-crystal-bio-solutions) - [About us](https://www.crystalbiosolutions.com/about-us) - [Contact](https://www.crystalbiosolutions.com/contact-us) - [Email \>](mailto:cbs_bd@crystalpharmatech.com) - [Contact Form](https://www.crystalbiosolutions.com/contact-us) - [Our Locations](https://www.crystalbiosolutions.com/locations) - [Crystal Group \>](https://www.crystalpharmatech.com/) - [Crystal Pharmatech](https://www.crystalpharmatech.com/) - [Crystal NAX](https://www.crystalnax.com/) - [Privacy Policy](https://www.crystalbiosolutions.com/policies/privacy-policy) - [Terms of Service](https://www.crystalbiosolutions.com/policies/terms-of-service) Copyright © 2026 Crystal Bio Solutions, All rights reserved Cookie Settings