NIH signs on IDT Biologika to manufacture clinical trial supply

By Maggie Lynch contact

- Last updated on GMT

(Image: Getty/Lucshen)
(Image: Getty/Lucshen)

Related tags: Nih, Biologics, Phase, IND applications

The NIH has contracted IDT Biologika to manufacture five E. coli master cell banks for BLA, IND, and Phase I/II 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.

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