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cGMP Manufacturing

Cell-Based Product cGMP Manufacturing

Cognate is a fully integrated contract BioServices organization providing the highest level of cGMP Cell-Based Manufacturing and quality expertise to clients who are focused on the commercialization of cell-based products. Our comprehensive service package supports companies in the specific areas of Preclinical Research, Assay Devlopment, Regulatory Services, Process Development, Process Scale-up and cGMP Manufacturing.

Cognate Operates cGMP Compliant Manufacturing:

	Experienced Manufacturing and Quality Staff in cGMP Manufacturing of Cell-Based Products
	Memphis facility US FDA Inspected
	Validated Class 10,000 (ISO Class 7) Production Suites
	Quality Control (QC) Laboratories

Our Comprehensive Package of Cell-Based cGMP Product Manufacturing Services:

	Large-Scale cGMP-Compliant Production of Cells for Commercial Applications or Clinical Trials Including the Use of Closed System Manufacturing Configurations
	Preparation of cGMP Master and Working Cell Banks
	Preparation of Raw Material Specifications, Standard Operating Procedures (SOPs) and Master Batch Records
	Cryopreservation Process Development and Optimization
	Manufacturing Process Validation from Design to Implementation
	Materials Management System
	cGMP Assay Transfer to QC and Assay Qualification / Validation
	Preparation of Raw Material Specifications, SOPs and Master Batch Records
	Materials Management System
	Shipping Validation Protocols
	Quality Control Testing
	cGMP assay transfer to QC and assay qualification
	Bioburden, mycoplasma and endotoxin testing
	Design and implementation of product release QC testing and characterization assays (including functionality assays)
	Stability testing for customized cell culture reagents and products

To print this information:
CB GMP Manu.pdf
CB Memphis.pdf