Current major assignment from the U.S. National Institute of Allergy and Infectious Diseases (NIAID)
IDT Biologika is developing a vaccine against respiratory syncytial virus (RSV) for the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. Department of Health and Human Services. A few weeks ago, the Dessau-based specialist in biotechnological vaccines and pharmaceuticals received its second task order as part of a ten-year contract. The assignment supports early research and development projects, including GMP manufacturing of Phase I/II clinical material for inclusion in Investigational New Drug (IND) applications and/or Biologic License Applications (BLA).The company is thus continuing to broaden its commitment to the growth market for viral vaccines.
Since the sale of its animal health division in June 2019, IDT Biologika is strategically focusing on contract development and manufacturing of vaccines, medical products for gene therapy, sterile liquids and lyophilized biologics. “This major order from the NIAID is another important step in implementing our strategy,” CEO Dr. Jürgen Betzing said at the CPhl Worldwide trade fair in Frankfurt. Already in July, IDT inaugurated a state-of-the-art production facility for viral vaccines, with an investment volume in the double-digit million euro range, at its company headquarters in Dessau. This new multifunctional vaccine building provides flexible production conditions that enable IDT to meet the requirements of current and future customers.
“The developments of recent months prove that we’re on the right track,” continues Betzing. “Around the world, companies in the biopharmaceutical industry, state institutions and scientific research institutes trust IDT’s services. The demand for solutions in this area is seeing significant double-digit growth. This long-term contract with the NIAID, as well as other successful transactions, underline the market’s trust in our technological capabilities and our flexibility and reliability.”
Development of the new vaccine in the U.S.
As part of the contract with NIAID, IDT Biologika will perform development services at its U.S. site in Rockville, Maryland, to adapt the current growth of Vero cells to a scalable process to produce live attenuated Respiratory Syncytial Virus (RSV). This includes GMP-compliant contract manufacturing of Phase I/II clinical material for applications as an Investigational New Drug (IND) and for approval applications in the form of Biologic License Applications (BLA). RSV causes infections of the lungs and airways that are common in children under two years old.
“The Rockville site’s size and its flexible technologies are well suited for the complex processes used in preclinical projects and Phase 2 projects. These include fully integrated GMP-compliant end-to-end services in BSL2 facilities that meet the requirements of the U.S. Food and Drug Administration (FDA),” explains Betzing. “Continuous coordination with IDT Biologika’s headquarters in Germany ensures that we are also able to produce development products on an industrial scale at a later stage.”