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Assay Development

Assay Development

Cognate provides a broad range of analytical test methods, development and testing services for cell-based, products. Our experts understand assay development for early product research, process development, cGMP processes and quality control release testing. Cognate has a wide-range of testing and data analysis capabilities to support client product development needs. We have demonstrated experience with in vitro and in vivo assay development and analysis.

Our Comprehensive Package of Assay Development Services:

	Development of Cell Product Characterization Methods and Assays
	Quality Control In-Process and Product Lot Release Assays
	Custom Assay Development
	Potency Assay Development
	Development of Immune Monitoring Assays for T-Cells and other Immune Effector Cells
	Development of Antibody Response Monitoring Assays for in Preclinical Animal Studies and Human Clinical Trials
	In Vitro and In Vivo Immune Response Assays to Assess Stem Cell Immunogenicity
	Cell-Tracking For Biodistribution Studies - Experience With a Variety of Labeling Techniques Including Transgene Expression, Dye Labeling Chromosome PCR, etc.
	Cell Activation and Proliferation Assays
	Gene Expression Analysis by: Qualitative / Quantitative PCR Western/Northern blotting ELISA
	Oligo - and Antibody-based Microarray Analysis
	Assay Qualification and Validation for Pivotal Product Registration Trials
	Technology Transfer of Developed Assays to Client from Cognate

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CB Assay.pdf