WHY U2XLab?
From Method Development to Sample Analysis
Full-Cycle Bioanalytical Service
A Full-Cycle Clinical Trial Partner
Pharmaceutical & Bioanalytical Service
01
Method Development
- Optimization of analytical methods based on analytical goals and candidate characteristics
- Application of diverse analytical platforms, including ELISA, LC-MS/MS, and Flow Cytometry
- Strategic consulting on analytical method development
02
Method Validation
- Execution of validation in strict compliance with FDA, EMA, MFDS, and ICH guidelines
- Assurance of data integrity and reliability under GCLP-certified conditions
- Preparation of method validation reports and support for regulatory submissions
03
Bioanalysis
- Dedicated execution of clinical trial specimen analysis
- Real-time monitoring of project progress and analytical result reporting
- Operation of a dual verification system for data quality
Dedicated Project Management
Quality-Driven Project Management
Assignment of an experienced and dedicated Project Manager (PM)
Prompt response to sponsor inquiries
01
Scientific Expertise
- Expert advisory on analytical design and strategy
- Global bioanalysis and operational support for clinical trials
02
Customized Solution
- Proposal of analytical strategies tailored to project characteristics
- Analytical design tailored to disease and sample characteristics
- Sponsor-tailored operational management
03
Responsive Communication
- Assignment of a dedicated Project Manager (PM)
- Regular updates on project progress and status
- Agile response to additional requirements and comprehensive issue management
Specialized PBMC Processing Services
Global PBMC Projects Completed : 20+
Monthly Processing Capacity: 300+ Vials
Minimum Processing Time: Within 4 Hours
01
PBMC Expertise
High Processing Capacity
Processing capacity of over 300 PBMC vials per month, backed by strict accuracy and reproducibility
Experienced Scientists with Extensive Bioanalytical Expertise
Extensive hands-on experience and technical expertise in PBMC and BMMC isolation
02
GCLP-Based Quality Management & Training System
Rigorous Quality Management
Consistent and highly reliable PBMC isolation through GCLP-compliant standardized processes
Training & Competency Assessment
Professional workforce management via SOP-based training and regular competency assessments, ensuring the delivery of customized services
03
Reliable Operational System
Dual Validation Process
Operation of a dual verification system to minimize errors during specimen processing and ensure result accuracy
Separation Equipment & Storage Facilities
Isolation Equipment: Biological Safety Cabinet (BSC), Centrifuge, Cell Counter
Storage Facilities: Deep Freezer, Liquid Nitrogen (LN₂) Storage Tank