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.

Related news

Show more

Related products

show more

Automating clinical trials for success

Automating clinical trials for success

Formedix | 06-Oct-2021 | Technical / White Paper

This article gives gives a brief overview of why automation is absolutely essential for clinical trial success.

What should a clinical metadata repository do?

What should a clinical metadata repository do?

Formedix | 26-Jul-2021 | Technical / White Paper

Choosing a clinical metadata repository (MDR) software can be a tough task as the capabilities and features of your chosen MDR could make or break your...

Adapting supply chains to new ways of working

Adapting supply chains to new ways of working

World Courier | 15-Jul-2021 | Technical / White Paper

COVID-19 has changed the way we operate. We have adapted our supply chain solutions to meet our clients’ requirements while following World Courier standard...

Empowering Clinical Trial Sponsors with Analytics

Empowering Clinical Trial Sponsors with Analytics

PerkinElmer | 14-Jul-2021 | Technical / White Paper

Is your Clinical Data Review creating problems or solving them? Take Control of Your Data. PerkinElmer Informatics Clinical Solutions, powered by Tibco...

Related suppliers

Follow us

Products

View more

Webinars