Leading Contract Development and Manufacturing Organization (CDMO) MabPlex International, serving the global biopharmaceutical and biotechnology industries with sites in China and the United States, confirmed that an Investigational New Drug (IND) application has been approved by the U.S. Food and Drug Administration (FDA) for one of the company’s undisclosed customer’s proprietary antibody drugs.
The IND program is the means by which a pharmaceutical company obtains permission to start human clinical trials and to ship an experimental drug across state lines, within the United States, to clinical investigators before a marketing application for the drug has been approved.
MabPlex, which offers 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, was contracted to develop and manufacture the product from cell line development to IND filing in both the United States and China.
MabPlex’s high standards in development and cGMP quality management have been recognized by regulators in the United States, Australia and China, demonstrating the strength of the company’s global CDMO services…
For this project, 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, MabPlex will assist in completing the IND filing for the Chinese NMPA 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,” noted Jianmin Fang, Ph.D, Chairman and Chief Executive Officer of MabPlex International.
“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.
Founded in 2013, MabPlex currently has two sites in China (Yantai and Shanghai) and one site in the United States (San Diego, CA).