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Scientist in PPE wearing safety goggles and a mask examines a pipette sample in a GLP laboratory, representing Crystal Bio Solutions scientific depth and state of the art facilities.

Scientific Depth,
Technical Breadth.

Leveraging decades of experience and scientific expertise to deliver high-quality data across diverse therapeutic modalities and study designs.

 Blue gloved hands holding a 96 well plate with red assay wells next to a microscope, illustrating end to end assay development and high quality data generation at Crystal Bio Solutions.

One Stop
from Strategy
to Approval.

From complex assay development to regulatory-compliant study execution, our expert team guard your every step.

 A group of colleagues collaborating at a desk; two women reviewing documents while smiling, with a laptop open in front of them, and a bearded man partially visible on the left.

Global Experts,
Local Solutions.

Explore our global network of therapeutic-specific key opinion leaders, subject-matter experts, vendors, and pre-qualified investigator trial sites in the United States, Europe, and Asia.

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Services & Solutions

Providing one-stop solutions with customized strategies.
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. Bioanalytical
Biomarker Expert-driven, GLP-compliant bioanalysis and biomarker solutions built for diverse modalities and innovative pipelines. Wide view of a modern analytical laboratory with chromatography and MS instruments and a staff member in PPE, illustrating CMC method development, characterization, and release or stability testing in Cranbury, New Jersey. Characterization and
CMC Analytical Beyond just testing: customized assay development for complex biologics, extended characterization, and extensive hands-on expertise. 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 We provide strategic insight backed by robust data gathering and interpretation, to accelerate decision-making from IND to NDA. 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
Affairs Navigating global regulations with confidence is a challenge. We provide submission-ready strategies built on deep FDA and ICH expertise.
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Techniques & Capabilities

Providing breadth and depth of scientific and technical expertise.
Immunoassay Sensitive and specific assays to quantify biologics and biomarkers. Close view of a multichannel pipette dispensing blue samples into a 96-well microplate in a clean GLP lab, illustrating high-throughput immunoassay workflows for PK, ADA, and biomarker testing at Crystal Bio Solutions. Molecular Assay Advanced nucleic acid–based methods for gene and cell therapies. qPCR thermal cycler with amplification curves on screen, DNA helix graphic in the background, and PCR tubes on a rack, representing molecular methods for gene and cell therapy programs at Crystal Bio Solutions. Cell-based Assay Functional assays to evaluate drug activity and safety in vitro. Scientist at a bench microscope with an inset of fluorescently labeled cells, highlighting functional cell-based assays used to evaluate potency, receptor activity, and safety in vitro. LC-MS High-precision mass spectrometry for quantitative and structural analysis. Triple quadrupole LC-MS system next to a monitor displaying chromatograms and mass spectra, indicating quantitative and structural analysis for biologics, ADC payloads, peptides, and biomarkers. Physiochemical Characterization of drug stability, purity, and critical quality attributes. Close view of an autosampler with capped vials loaded into a biophysical analyzer, representing physicochemical testing for stability, purity, aggregation, and critical quality attributes. Method Transfer Seamless transfer and validation of methods across global labs. Analytical scientists in a bright lab reviewing racks and documents, illustrating method transfer and lifecycle support across global sites with SOP alignment, comparability, and verification testing.
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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.
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News and Blogs

DNA

Nucleic Acids

Discover Nucleic Acid eXcellence, NAX. Our new project focused on DNA, RNA and LNP design and formulation

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