ALACHUA, Fla.--(BUSINESS WIRE)--Nanotherapeutics, Inc., a contract development and manufacturing organization (CDMO), announced today that the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), has awarded the company a contract for advanced biologics manufacturing services as part of a multiple award IDIQ (Indefinite Delivery/Indefinite Quantity) pool. The contract has a maximum ceiling of $159.4 million and a performance period of up to 10 years.
“Our contract with the NIAID represents a major achievement for the company,” stated Robert V. House, Ph.D., Nanotherapeutics’ Senior Vice President, Government Contracts. Having successfully fulfilled numerous contracts for various divisions of the U.S. Government over the past 16 years, this new award is a reflection of the strength of Nanotherapeutics’ advanced biologics expertise and proven development and manufacturing capabilities. We are pleased to begin work on the initial task order and are honored to have been chosen to fulfill such an important, long-term contract.”
Under terms of the contract, Nanotherapeutics will support the NIAID’s efforts in basic and applied research to develop and evaluate a range of therapeutics and diagnostics. Activities will include those commonly associated with the development of biopharmaceutical products for treating or diagnosing infectious disease that are required for submission of applications including, but not limited to, an Investigational New Drug (IND) Application and/or Biologic License Application (BLA). Specific services will include product development planning and evaluation; analytical assay development and product characterization; process development; cGMP manufacture; regulatory activities and documentation; and management support. All work will be conducted at Nanotherapeutics’ 183,000 square foot, state-of-the-art, multi-purpose-multi-product, Biosafety Level-3 capable Advanced Development and Manufacturing (ADM) Facility located in Florida.
James M. Matthew, President, Chief Executive Officer and Chief Financial Officer of Nanotherapeutics, added, “We are delighted to have the opportunity to expand our relationship with the NIAID. The award of this major government contract speaks volumes about the strength of our team, proprietary technology platforms and expertise within the area of infectious disease. We look forward to supporting the Government’s ongoing efforts and leveraging the exceptional capabilities of our new ADM facility for both government and commercial contracts in the future.”
This project has been funded in whole or in part with Federal funds from the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under contract No. HHSN272201600006I.
About Nanotherapeutics, Inc.
Nanotherapeutics is a contract development and manufacturing organization (CDMO) that operates a U.S.-based 183,000 square foot, state of the art, single-use, multi-purpose-multi-product, BSL-3 capable facility offering clients extensive capabilities, including a pilot facility for performing optimization of upstream, downstream and formulation functions, bulk cGMP manufacturing, and analytical development for proteins, antibodies, viral vaccines and gene therapy drug products. The Company provides expertise from preclinical through FDA licensure in a variety of production platforms, including microbial and mammalian cell culture. The Company also owns a second, Czech Republic-based, 165,000 square foot, 6,000-liter capacity BSL-3 facility for manufacturing vaccines using its proprietary Vero cell platform. For more information, visit the Company website at www.nanotherapeutics.com.