One-Stop Shop for End-to-End Analytical Services
Comprehensive bioassay and analytical solutions purpose-built for Cell and Gene Therapy and Biologics — from assay development and qualification through testing and IND/BLA submission support.
What We Offer
Detailed Service Capabilities
Select a platform below to explore the specific tests and capabilities we offer.
Cell-Based Assays
Functional cell-based assays designed to characterize biological activity, potency, and mechanism of action for CGT and Biologics programs.
Tests & Capabilities
- Cell-Killing Assay
- Cell Proliferation Assay
- Cytokine Release
- Cell Activation
- Apoptosis
- Reporter Gene Assays
- Gene Delivery Efficiency
- Target-Specific Functional Cell-Based Assays
- Potency Bioassay Testing Services
Designed for Every Stage of Development
Our analytical services support the full development lifecycle — from early discovery through regulatory submission.
Lead Candidate Screening and Selection
Rapid, high-throughput analytical support to identify and advance the strongest candidates.
Formulation and Process Development
Analytical methods to characterize and optimize formulations throughout process development.
Stability Studies
Validated stability-indicating methods to support regulatory stability programs.
PK/PD
Biomarker and immunogenicity assays supporting pharmacokinetic and pharmacodynamic studies.
Comparability for Scale-Up
Side-by-side analytical comparability studies to support manufacturing process changes and scale-up.
IND PoC Data Package
Phase-appropriate assay development and validation data packages to support IND filings.
Ready to get started?
Contact us to discuss your project requirements. Our team will design a customized analytical program to meet your timelines and regulatory goals.
Request a Consultation