Cell Culture & Cell-Based Bioassay Services

Our BSL-2 facility handles all cell types including immortalized cell lines (MDCK), primary cells, and diverse tissue samples from brain, blood, and milk. We support both monolayer and suspension formats, enabling comprehensive testing across multiple biologic drug modalities including peptides, mAbs, proteins/enzymes, ADCs, gene therapies, cancer vaccines, and cell therapies. Our extensive experience covers testing requirements throughout the entire development lifecycle. 

We deliver custom potency assay development and validation per ICH guidance, alongside comprehensive cellular analysis. Potency assays are arguably the most important cell-based bioassays, as these assessments are needed to demonstrate proof of activity. Our testing capabilities include: 

• Cell proliferation and viability determination 

• Cytokine screens and reporter gene assays 

• Gene expression and cell signaling assays 

• Ligand binding assays 

• Cell death and apoptosis testing 

• Cytotoxicity studies 

• Drug target identification and isolation from tissue samples 

Access our established platform methods for rapid implementation, significantly reducing development time by eliminating the need to start and develop assays from scratch. Get complete support from discovery through commercialization, including method optimization. Our solutions encompass stability assessments, routine lot testing, media qualification and characterization. We provide IND/BLA submission support and regulatory consulting throughout your development journey. 

1. Comprehensive bioassay capabilities: 

• Potency assays: Custom bioassay development and validation per ICH guidance, including biologic drug cellular uptake and cellular response to a biologic drug 

• Bioassay method optimization 

• Drug permeability assays 

• Cell proliferation and viability determination (MTT/MTS assays) 

• Cytokine screens 

• Reporter gene assays by fluorescence 

• Gene expression analysis 

• Cell signaling assays 

• Ligand binding assays 

• Cell death and apoptosis testing 

• Cytotoxicity studies 

• Drug target identification and isolation from tissue samples 

• Biologic drug characterization 

• Basic research and drug discovery 

• Biologics License Application (BLA) submission support 

• Routine lot testing 

• Potency testing within a stability assessment 

• Media qualification and characterization 

Our team operates from Life Sciences hubs across the world, providing global access to our expert capabilities. Find out where your nearest Life Sciences hub is on our Locations Page. 

Our team provides tailored bioassay solutions for various applications, leveraging accumulated knowledge to eliminate the need for developing assays from scratch. Leading biopharmaceutical companies rely on our cell culture facility and bioassay laboratory to verify their drug objectives and development programs. We understand the unique challenges of large molecule therapies. Our expertise spans from determining candidates and making initial investment decisions to lot release and stability testing for biologic drug development.