* GMP Facility Compliant under FDA CFR PART21 AND ATMPs Regulations.
** Experienced in CMC Studies for Global IND Application & GMP Manufacturing for IIT and Clinical Trials : T cell projects / Cell and gene therapy projects
** Experienced in Integrated IND Application Service (Succeeded in IND Applications),Acquired US IND approvals.
--Possible IND filling U.S and Europe.
I) From plasmid to cell therapy products (Plasmid, Lentiviral Vectors, Cell therapy Products): acquiring IND approvals assisted.
* Timeline from microbial banking to first cell product primary batch : 7 months .
II)Process development and GMP manufacturing--Analytical development & qualification--Quality control and stability study--
Preclinical assessment and clinical trial protocol draft--Revision of materials of IND--Application
