IDT Biologika announced the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services, has awarded the company a new Task Order within the 10-year Indefinite Delivery, Indefinite Quantity (IDIQ) contract no. HHSN272201800011I to provide process development activities and production of a vaccine against the Respiratory Syncytial Virus (RSV).
Awarded in 2018, the NIAID contract 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 new task order is for process development activities to adapt the current growth of Vero cells to a scalable process to produce live attenuated Respiratory Syncytial Virus (RSV). Respiratory syncytial virus causes infections of the lungs and respiratory tract that commonly affect children below the age of 2. The development and production activities will be performed at the IDT Biologika Rockville facility in Maryland (USA).
“It is a great honor to be awarded this Task Order. Our state-of-the-art manufacturing facility located in Rockville is well positioned to serve the current Task Order requirement. It contributes perfectly to the new strategy of IDT Biologika of supporting customers in developing and manufacturing vaccines and biological medicines that help fight diseases all over the world” said IDT Biologika Chief Executive Officer Dr. Jürgen Betzing.
Recently the company announced it is to concentrate on human vaccines and biologics, having transferred the animal health business to the French veterinary health group Ceva Santé Animale. IDT Biologika offers global expertise from an almost century of experience in vaccine development and manufacture and now specializes in the contract development and manufacturing of vaccines, gene therapy medicinal products, sterile liquids and lyophilized biologics.
“While the scale of our nimble technologies in Rockville allows us to specialize in the complex and varied processes inherent in preclinical through Phase 2 projects, we harmonize with the IDT Biologika headquarters in Germany to produce later-stage and commercial-scale products for our clients. We provide fully integrated services for GMP compliant end-to-end services in BSL2 facilities that satisfy FDA standards,” Dr. Betzing said.