Crystal Bio Solutions offers Biologics mass spectrometry, CMC analytics, PK, immunogenicity and biomarkers. Services should be matched to the intended study and assay requirements.
Profile review: 2026-11-05 · Fields retain their individual source dates. Undisclosed values are not zero; early or historical events do not establish the latest financing. Awards and acquisitions are distinguished from equity rounds.
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Technology, programs & evidence
Biologics mass spectrometry, CMC analytics, PK, immunogenicity and biomarkers
Specialist contract research/testing services
Crystal Bio Solutions describes bioanalytical and biomarker services, biologics characterization and CMC analytics, and clinical pharmacology. Its website lists immunoassay, molecular, cell-based, and mass-spectrometry techniques. Scope and quality requirements should be confirmed for the specific study and site.
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European Journal of Drug Metabolism and Pharmacokinetics
A study in European Journal of Drug Metabolism and Pharmacokinetics modeled subcutaneous aqueous progesterone using single-dose crossover data from 50 healthy Chinese postmenopausal women. Machine-learning approaches screened potential covariates before conventional PopPK evaluation. Height and body-weight effects remained statistically identifiable but had limited clinical significance. Simulated repeated-dose exposure is model-derived, rather than an observed efficacy outcome in fertility patients.
A Communications Chemistry study reports RaPiD-mAb-MS, combining plate-based preparation with direct-infusion mass spectrometry for antibody peptide mapping. The original abstract describes analysis of 96 samples in about 1.5–2 hours, routinely exceeding 95% sequence coverage, across 28 antibodies and more than 2,000 samples. The reported comparisons cover several modifications and sequence variants; broader method suitability still requires evaluation.
On November 5, PharmaIN reported conference findings from PHIN-001: 12 participants with Child-Pugh B cirrhosis received PHIN-214; 10 completed 28 days. The issuer described Grade 1–2 treatment-related adverse events and exploratory renal, hemodynamic and PK findings. The ongoing small Phase 1 study does not establish clinical benefit. This is a company conference announcement, not a peer-reviewed paper.
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