Our Services
What We Offer
Regulated Bioanalysis
Unitides, a bioanalytical CRO located in Madison (WI), specializes in LC-MS-based bioanalysis of small molecule drugs and metabolites, peptides, oligonucleotides, biologics and biomarkers with top quality and efficiency.
Key staff possess decades of experience in regulated bioanalysis
Critical infrastructure to support regulated bioanalysis
A state-of-the-art laboratory of 6,000 sq ft
67 active SOPs to support method validation and sample analysis per ICH M10
Onsite QAU
Electronic tracking for study samples/CALs/QCs
A 21 CFR Part 11 compliant system for 100% ‘paperless’ documentation
On-site and off-site instrument data backup
Whole-building power backup generator
24/7 temperature/humidity monitoring
Successfully completed many method validation and sample analysis projects to support GLP and clinical studies
Established relationship with >25 sponsors, including multiple top pharma and biotech companies
Selected as the preferred provider for LC-MS-based bioanalysis of protein biomarkers for a leading pharma company
Non-Regulated Bioanalysis
Unitides has extensive and diverse experience in LC-MS/MS-based bioanalysis. Our platforms include Sciex 6500+ coupled with Shimadzu UHPLC (LC40), LC-Fluorescence, and LC-UV systems. The following are example projects we can support currently.
Discovery bioanalysis of small molecules, peptides, and oligonucleotides (i.e., ASO and siRNA)
Discovery bioanalysis of biologics (i.e., mAbs, ADCs, and bispecifics) via immunocapture (IC) LC-MS/MS, IC-LC-UV, and IC-LC-HRMS
Bioanalysis to support dose range finding (DRF) studies
Method feasibility, development and pre-validation/qualification
Bioanalysis of biomarkers (i.e., small molecules, peptides, and proteins)
In vitro incubation and bioanalysis
Dose solution analysis
Biorepository services
Bioanalytical consulting