Crystal Bio Solutions, part of Crystal Group

About Crystal Bio Solutions, part of Crystal Group

Crystal Bio Solutions is a U.S.-based CRO built on scientific depth across bioanalysis, biologics characterization, and quantitative clinical pharmacology — generating the data and mechanistic insight that complex biologics programs depend on. Our science is led by people who built and ran bioanalytical and clinical pharmacology functions inside global biopharma. Where standard platforms fall short, we develop the method. Our teams design and validate first-time-right assays for modalities that resist routine approaches — ADCs requiring hybrid ligand-binding and LC-MS strategies, oligonucleotide and nucleic acid therapeutics, cell-based and immune-cell readouts, and biomarkers in difficult matrices — from early feasibility through GLP/GCLP validation. Our GLP/GCLP-compliant bioanalysis and biomarker laboratories in Pleasanton, California combine ligand-binding, LC-MS, flow cytometry, and molecular biology platforms with immunogenicity assessment and Integrated Summary of Immunogenicity (ISI) authoring for BLA submissions. Our biologics characterization and CMC analytical laboratories in Cranbury, New Jersey and Natick, Massachusetts specialize in high-resolution LC-MS–driven structural and functional analysis, resolving the molecular attributes that determine quality, comparability, and performance. Our quantitative clinical pharmacology group connects that evidence to clinical decisions — biomarker strategy, exposure–response modeling, pharmacometrics, and regulatory documentation. Because these capabilities sit within one organization, sponsors can run first-in-human programs under a single contract rather than coordinating multiple vendors. As part of Crystal Group, we pair this depth with the infrastructure of a global pharmaceutical development organization — reducing development risk with data sponsors can act on.