GenScript ProBio Congratulates TG ImmunoPharma on FDA Clearance of Clinical Trial for TGI-5 Monoclonal Antibody
Recently, Hefei TG ImmunoPharma Co., Ltd. (TG ImmunoPharma), a partner of GenScript ProBio, announced FDA clearance of its IND application for self-developed monoclonal antibody drug (project code TGI-5). GenScript ProBio warmly extends congratulations on this major milestone achievement. Currently, no product with the same target has been approved for marketing at home or abroad. The product was provided with pre-clinical CMC services by GenScript ProBio, a strategic partner of TG ImmunoPharma.
GenScript ProBio’s specialized biologics CDMO platform plays a key role in the TGI-5 application process of TG ImmunoPharma and contributes significantly to obtaining clinical approval from FDA. The integrated CDMO services, including cell line development, upstream and downstream process development, and clinical sample production, help the client complete the CMC process quickly and efficiently, and ensure the process stability and product quality, data reliability, providing solid support for the smooth delivery of the project. With professional technical strength and excellent quality, GenScript ProBio has become an critical partner of TG ImmunoPharma in achieving this important milestone, and ImmunoPharma will continue to bring more innovative treatments to global patients in the future.