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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

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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.

All-around support

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. 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. Clinical Pharmacology Modelling and success prediction of your drug, translation to humans and dosing. cbs-home-cmc-analytical-lab-instruments 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. Regulatory Guidance and documentation for FDA submissions (IND, BLA, ICH).

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