Analytical Services for
Cell and Gene Therapy
& Biologics
At Elevalue Laboratories, we're committed to accelerating the development of groundbreaking therapies through comprehensive bioassay and analytical solutions — from assay development to IND & BLA submissions.
IND → BLA
Full Regulatory Pathway Support
5+
Assay Platforms
CGT & Biologics
Specialized Focus
Phase-Appropriate
Method Validation
One-Stop Shop for End-to-End Analytical Services
Comprehensive analytical support from assay development and qualification through testing — designed for the unique demands of CGT and Biologics.
Potency / Bioassays
Industry top-notch expertise in potency/bioassay development for Biologics and Cell & Gene Therapies, including MoA-reflective potency assays and QC-ready development.
Flow Cytometry
Multi-color flow panel development, CAR expression analysis, tetramer staining, cell purity and identity assessment, and immune cell differentiation.
Cell-Based Assays
Cell-killing, proliferation, cytokine release, apoptosis, reporter gene, and target-specific functional assays for comprehensive cellular characterization.
qPCR
RNA quantitation, target silencing, tissue specificity analysis, and durability assessment of RNA-LNP formulations.
Ligand-Binding Assays & MSD
HCP, host cell DNA, cytokine quantitation, ELISA potency measurement, biomarker analysis, immunogenicity, and PK/PD studies.
Assay Transfer & Validation
End-to-end assay transfer, analytical method qualification and validation, sample testing, and control strategy with specification justification.
Empowering Your Journey from Concept to Commercialization
Cell and Gene Therapy stands at the forefront of medical innovation, promising transformative treatments for previously incurable conditions.
At Elevalue Laboratories, we specialize in complex bioassay development and comprehensive analytical solutions. Our expertise accelerates your path to IND and BLA submissions through assay development, phase-appropriate analytical method validation, and comprehensive testing services for CGT and Biologics.
Let's ConnectOur Extensive Services Include
- Analytical Development for Cell and Gene Therapy and Biologics
- Potency assay development for CGT and Biologics for Initial IND and beyond
- Fast, Customized, QC-ready Assay Development
- Characterization Assay Development
- Assay Transfer
- IND-enabling analytical services
- Control Strategy with Spec Justification
- Custom Project
The Elevalue Laboratories Difference
Specialized Expertise in CGT & Biologics
Elevalue Laboratories is dedicated to the complexities of CGT and Biologics, bringing specialized knowledge and advanced methods that meet the unique demands of this field. Our team addresses the rigorous standards and challenges associated with these groundbreaking therapies.
Enabling Accelerated Pathways to IND & BLA
Speed and precision are crucial in the biotech industry. We prioritize both by enabling accelerated pathways through method validation that streamlines the route to successful IND and BLA submissions. Our experience helps you navigate regulatory requirements with confidence.
Comprehensive Analytical Solutions
From concept through commercialization, our laboratory offers a seamless suite of services — including bioassay development, analytical testing, and data analysis. One reliable partner for your project's entire analytical journey.
Speed and Precision
Speed and quality are both crucial in this sector. Quality is central to Elevalue Laboratories' core values. We are committed to delivering high-quality services with the speed required to meet your timelines and goals.
Ready to accelerate your IND or BLA submission?
Partner with Elevalue Laboratories for specialized CGT and Biologics analytical support. High quality, speed, and scientific expertise — from assay development to commercialization.