Integrated personalized cell technologies for improving health outcomes in children and adults
We will enable UW researchers and clinicians as well as external partners transition cell therapies through FDA CBER IND-enabling and Phase I/II clinical studies.
We assist in development of Standard Operating Procedures and Batch Production Records in support of new FDA CBER INDs.
Our team optimizes the manufacturing processes, including FDA-compliant production of variety of cell types, advanced cell manufacturing and cell enrichment.
We offer services to assist researchers and clinicians in various aspects of IND filing including writing/reviewing of CMC and supporting reports.
We participate in single center and multi center trials for academic and clinical-stage companies in cell technology space.
We partner with biotechnology and medical device companies to integrate their semi-automated and fully automated devices to improve GMP workflow.
We welcome academic and industry partners to work with us in order to design new technologies/devices or improve existing technologies/devices that can be used in the GMP cell manufacturing laboratories.
We serve as a beta site for testing any processes that will improve GMP laboratory practices.