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.