Co-Director: Zhuyong Mei, M.D.
We provide GMP manufacturing of therapeutic grade cellular products and viral and non-viral vectors for use in early phase clinical trials and to facilitate the preparation of the associated regulatory documentation.
Services
- Manufacturing of a wide range of cellular therapy products and associated intermediates for use in cancer therapy
- Manufacturing of viral (adenoviral, retroviral and herpes virus) and non-viral vectors, and associated master and working cell banks, to support clinical gene therapy studies
- Provision of assistance in preparing the appropriate regulatory documentation for submission of investigational new drug applications to the FDA
Charge Back Fees and Forms
- Due to the wide range and unique nature of the products manufactured, fees are determined on a per product basis.
- Submission forms for vector manufacturing can be obtained by contacting Zhuyong Mei (see right).