The CTSI Good Manufacturing Practice, or GMP, Facility manufactures phase I & II clinical trial immunotherapeutic investigational drugs, drug substances, and intermediates.
How can we help?
The CTSI GMP Facility is committed to your success from concept to clinical trial reality. Our specializations include:
Our facility is dedicated to the production of phase I & II clinical trial immunotherapeutic investigational drugs, drug substances, and intermediates. We understand the critical nature of your projects and provide top-tier GMP manufacturing services.
With 3450 sq ft of cutting-edge production space, our facility is equipped with the latest technology and infrastructure necessary to support your phase I or II immunotherapeutic projects. We prioritize efficiency and precision in every aspect of our operations.
Our personnel have a wealth of knowledge and expertise in tech transfer, batch records, specification creation, analytical method development, and validations to meet phase-appropriate regulatory requirements.
Whether you’re working on an Investigational New Drug, or IND, application, or FDA approval, we’re here to help. We are currently supporting eight IND applications and four pending FDA approvals. Our facility has a proven track record in the successful development and manufacturing of cell therapy, CAR T Cells, and RNA-loaded Lipid Nanoparticles.
Interested in using our facilities? Want more information? Please contact…