Precision & Performance for Cell & Gene Therapy Trials
At MLM, we specialize in high-complexity services that support the unique needs of Cell & Gene Therapy (CGT) and Advanced Therapy Medicinal Product (ATMP) trials. From global PBMC processing to advanced immune profiling, our capabilities are purpose-built to accelerate translational research and deliver confidence in every sample.
Global PBMC Network Access
Access a trusted global network for Peripheral Blood Mononuclear Cell (PBMC) isolation and processing, supported by harmonized SOPs across all collection sites. With centralized oversight, we ensure sample quality and consistency—critical for reproducible immune monitoring.
- Standardized PBMC protocols globally
- Pre-qualified partner sites for CGT requirements
- On-site training and assay harmonization support
Cryopreservation & Biostorage
MLM safeguards irreplaceable CGT samples with precision cryopreservation protocols and long-term storage across North America and Europe.
- Liquid nitrogen, -80°C, and scalable storage solutions
- Integrated storage with our testing workflows—no transport delays
- 24/7 monitoring, emergency backup, and GxP compliance
Real-Time Sample Tracking & Reporting
From vein-to-freezer to results delivery, our proprietary Sample Management System® provides full visibility and data integrity.
- 100% traceable chain of custody
- Automated alerts and site-specific dashboards
- Samples retrievable within 10 minutes
Advanced Flow Cytometry
From multi-color panels to rare cell detection, we offer expert-designed and custom-developed flow cytometry assays for deep immunophenotyping.
- High-dimensional flow (up to 12+ colors)
- Cell viability, transduction efficacy, immune cell function
- GMP/GLP-compatible workflows and data handling
Cytokine & Biomarker Testing
Measure therapeutic impact through validated cytokine and soluble biomarker panels using highly sensitive multiplex technologies.
- Broad portfolio of inflammation, immuno-oncology, and CGT-relevant biomarkers
- Singleplex and multiplex options
- Customized panels available on request
Multiplex Assays
Maximize insights per sample with multiplexed immunoassays, delivering higher throughput and cost-effective quantification.
- Luminex®, MSD®, Ella™ and other platforms
- Validation support for exploratory biomarkers
- Optimized for small-volume CGT sample types
Specialized Assay Expansion
Your therapy is unique—your assays should be too. We partner on custom assay development and expansion to meet evolving trial needs.
- Assay transfer, bridging, and co-development
- Preclinical to clinical assay validation
- Fit-for-purpose and exploratory platforms
HLA Typing & Genetics
Ensure compatibility and safety through HLA typing and genetic testing services designed for precision CGT programs.
- HLA Class I & II typing (qPCR and sequencing)
- S2 lab capacity in Europe + North American compliance
- GLP-grade reporting, rapid turnaround
Safety Testing
MLM delivers global safety testing capabilities with harmonized platforms, ensuring compliance and consistency.
- Hematology, clinical chemistry, serology, cytokines
- 365-day availability with 5-hour TAT
- Harmonized reporting across U.S. and EU sites
Histology & Tissue Analysis
Support in-depth preclinical or translational tissue analysis with flexible histopathology solutions.
- IHC, ISH, IF, multiplex staining
- Whole-slide imaging and digital image analysis
- Over 900+ validated biomarkers
Long-Term Biostorage / Cryopreservation
Your samples, secured for the long haul. Our long-term biostorage solutions ensure sample stability and regulatory confidence.
- Over 20 years of storage experience
- Ambient, refrigerated, frozen, and cryogenic options
- Redundant systems and global harmonization
Why MLM for CGT & ATMP Trials?
MLM is uniquely positioned to meet the demands of Advanced Therapy trials through:
- Validated, compliant workflows : GxP-aligned operations and harmonized global SOPs ensure full regulatory compliance and audit-readiness.
- Scientific assay expertise : Our PhD-led teams specialize in advanced immunology, biomarker validation, and custom assay design for complex biologics.
- Scalable infrastructure for complex programs : Global sample management, integrated cryostorage, and real-time tracking systems make us a true end-to-end lab partner.
Ready to Build Your Trial with Confidence?
Let’s accelerate your Cell & Gene Therapy program with precision, reliability, and flexibility at every stage.