MabPlex International Ltd, a leading and fully integrated Contract Development and Manufacturing Organization (CDMO) serving the global biopharmaceutical and biotechnology industries with sites in China and the United States by offering comprehensive (cell line) development, process characterization, conjugation optimization, cGMP manufacturing, and aseptic fill finish solutions for monoclonal antibody (mAb) and antibody-drug conjugate (ADC) therapeutics, announced today that an Investigational New Drug (IND) application has been approved by the U.S. Food and Drug Administration (FDA) for its customer’s proprietary antibody drug.
MabPlex was contracted to develop and manufacture the product from cell line development to IND ling in both the United States and China.
MabPlex provided fully integrated services from cell line development to final drug product including a complete CMC package in support of the United States IND submission. Additionally, the IND ling for the Chinese NMPA will be completed in the near future.
“This approval adds another milestone to our global repertoire of international IND submissions after the successful approval of an Australian IND last year,” said Jianmin Fang, Ph.D, Chairman and Chief Executive Officer of MabPlex International, Ltd.
“MabPlex’s high standards in development and cGMP quality management have been recognized by US, Australian and Chinese regulators demonstrating the strength of our global CDMO services,” Fang added.