NIH signs on IDT Biologika to manufacture clinical trial supply
IDT BIologika, a global vaccine and biopharmaceutical contract development and manufacturing organization (CDMO), has been awarded a task order from the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) to manufacture five E. coli master ell banks.
Germany-based IDT Biologika will manufacture the five master cell banks at its Rockville, Maryland facility, which its CEO Jürgen Betzing said is well-positioned to meet the requirements.
The Maryland facility was opened in 2015 and is equipped to handle process development, cell banking, current good manufacturing practice (cGMP) manufacturing, purification, and fill and finish services. IDT Biologika Corporation, a subsidiary of IDT Biologika, acquired the site from Aeras.
This contract is within the 10-year Indefinite Delivery, Indefinite Quantity (IDIQ) agreement with the NIAID. The 2018 agreement supports early research and development projects and provides manufacturing of Phase I/II clinical material for the use in Investigational New Drug (IND) applications and Biologic License Applications (BLA).
Vaccine development grants
The Coalition for Epidemic Preparedness Innovations (CEPI) also recently collaborated with IDT Biologika, granting the CRO $36m in 2018 to develop a vaccine against Middle East Respiratory Syndrome Coronavirus (MERS-CoV).
In 2016, IDT Biologika was also contracted by the Biomedical Advanced Research and Development Authority (BARDA) to provide live virus filling and finishing services at its Maryland facility.