# Crystal Bio Solutions a member of Crystal Pharmatech

> Crystal Bio Solutions is a U.S. contract research organization within Crystal Pharmatech that provides GLP/GcLP bioanalysis, biomarker testing, biologics CMC characterization, clinical pharmacology, and regulatory support to biotech and pharmaceutical drug developers.

- **Founded:** 2018
- **Headquarters:** Pleasanton, United States
- **Founders:** Alex M. Chen (Co-founder and CEO of parent Crystal Pharmatech; CEO of Crystal Bio Solutions), Shiaw-Lin (Billy) Wu (Co-founder and Chief Scientific Officer of Crystal Bio), Ye Gu (Co-founder and Chief Technology Officer of Crystal Bio)
- **Products:** Bioanalysis and biomarkers, Biologics characterization and CMC analytics, Quantitative clinical pharmacology, Regulatory affairs and medical writing
- **Notable:** Operates a 10,000-square-foot GLP/GcLP bioanalytical and biomarker lab in Pleasanton and a 5,300-square-foot CMC analytical lab in Cranbury., Published a neutralizing-antibody assay case study in which an adjusted dilution improved positive-control detection fourfold and drug tolerance fivefold., Added a quantitative clinical pharmacology division in September 2025.

## Products & services

- **Bioanalysis and biomarkers** — GLP/GcLP assay development, validation, sample analysis, pharmacokinetics, immunogenicity, biomarker testing, and related clinical sample logistics.
- **Biologics characterization and CMC analytics** — Mass-spectrometry, chromatography, biophysical, and potency methods for identity, structural variation, impurities, stability, and comparability.
- **Quantitative clinical pharmacology** — Population PK/PD, exposure-response, dose optimization, trial simulation, noncompartmental analysis, biostatistics, and SAS programming.
- **Regulatory affairs and medical writing** — Regulatory strategy, IND/CTA and BLA/MAA support, eCTD documentation, and authority interactions.

## Achievements

- Operates a 10,000-square-foot GLP/GcLP bioanalytical and biomarker lab in Pleasanton and a 5,300-square-foot CMC analytical lab in Cranbury.
- Published a neutralizing-antibody assay case study in which an adjusted dilution improved positive-control detection fourfold and drug tolerance fivefold.
- Added a quantitative clinical pharmacology division in September 2025.

## Latest updates

- **2026-08** — Announced an October scientific symposium on bioanalysis, biomarkers, immunogenicity, and clinical pharmacology.
- **2026-01** — Named Allan Cortes head of West Coast business development.
- **2025-09** — Launched quantitative clinical pharmacology and appointed Lorin Roskos to lead it.

## Links

- Website: https://www.crystalbiosolutions.com/
- LinkedIn: https://www.linkedin.com/company/crystal-bio-solutions
- Twitter/X: https://twitter.com/crystalpharma

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Last updated: 2026-09-28