Scientist loading a 96-well plate with a multichannel pipette during bioanalysis sample preparation.

Bioanalysis and Biomarker Services for Every Drug Development Phase

Crystal Bio Solutions provides end-to-end bioanalytical and biomarker support for complex biologics. Our GLP and GcLP compliant laboratories and quality system, together with experienced scientists can design, develop, qualify, and validate assays regulatory review. We cover immunogenicity and neutrality risk, PK and PD, exploratory and clinical biomarkers, and complete report packages that are eCTD ready. Central lab kit design, cold-chain logistics, and chain-of-custody tracking are also available when needed.

lmmunoassays Tiered immunoassays for various biological matrices utilizing multiplex and ultrasensitive ELISA, MSD, Gyrolab, Luminex, and SPX. Services cover NAb and ADA assay development, validation, testing, and assessment for bridging, isotyping, anty-PEG, etc.

LCMS High-resolution and triple quadrupole LC-MS for ADC, oligonucleotides, peptides, small molecules, and endogenous biomarkers. With multicomplexing, high sensitivity and selectivity methods, we address challenges when LBA fails.

Cell-based Assays Mechanism-aligned potency and activity readouts that include neutralizing antibody assays, reporter gene systems, and functional pharmacology endpoints. Assays are qualified or validated for phase-appropriate use.

Flow Cytometry Multiparameter immunophenotyping and receptor occupancy to support cell therapy and biomarker strategies. Services include panel design, controls and compensation, viability and rarity tracking, and validated analysis pipelines.

ELISpot Assays Quantification of cell-mediated immune responses for vaccines and CGT. Common analytes include IFN-gamma, IL-2, and granzyme B with qualified methods, clear acceptance criteria, and standardized data packages.

Molecular Biology qPCR and ddPCR for copy number and biodistribution, RNA-Seq and NanoString for expression profiling, and NGS workflows to support cell and gene therapy programs. Phase-appropriate validation and clear bioinformatics reporting are included.

Comprehensive Immunogenicity Assessment to Support Drug Approval Crystal Bio Solutions provides end-to-end solutions with a science-centric approach and customized strategy.

What we deliver:

Immunogenicity risk assessment and clinical strategy aligned to mechanism and patient population
Assay development, qualification, and validation with advanced platforms and techniques
Sample testing that includes ADA screening and confirmatory, titer, isotyping, drug tolerance, target interference, domain specificity, and neutralization capacity
Data analysis in the clinical setting: effect of anti-drug antibody on pharmacokinetics/pharmacodynamics, efficacy and adverse reactions
Complete documentation and eCTD-ready outputs, including validation reports, sample analysis plans, data packages, integrated immunogenicity summaries, CSRs, and responses to authority queries

Bioanalysis and Biomarker Services for Every Drug Development Phase

Drug Modalities We Helped

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