Sterilization Capacity for Vaccines and Therapeutics

An important strategic goal of the Administration for Strategic Preparedness and Response (ASPR) Biomedical Advanced Research and Development Authority (BARDA) and Defense Production Act (DPA) Title III Program is to support and facilitate development of the technological infrastructure within the domestic pharmaceutical manufacturing industry to provide new materials, products, capabilities, and manufacturing paradigms for the Nation. Specifically, ASPR, BARDA, and DPA Title III are seeking to expand domestic sterilization capacity to enable U.S. suppliers to support the production of 600 million vaccine doses within six to nine months with minimal disruption to the baseline public health supply chain. This increased capacity will support ASPR’s anticipated present and future requirements of domestic manufacturers contracted by the Federal Government to respond to a domestic public health emergency (PHE). In order to ensure sufficient manufacturing capability of sterile injectable

vaccine products and therapeutics for future domestic pandemic preparedness, the US Department of Health and Human Services (HHS) is leading the Industrial Base Expansion (IBx) of supplies and services to ensure adequate capacity of a variety of vaccine consumables, raw materials, vials, needles, and syringes for domestic consumption, while ensuring uninterrupted manufacturing of products supporting non-PHE requirements. HHS’s BARDA and DPA Title III Program have identified a requirement for sterilization capacity to support the COVID-19 pandemic response while ensuring adequate capacity for COVID-19 variants and future PHE demands. This requirement is becoming increasingly acute due to the reliance on unstable global sources of supply for Cobalt 60, and an increasing reliance on alternative and emerging technologies such as X-ray or dual Electron Beam (E-Beam)/X-ray sterilization capabilities. Strategic oversight for the Project Agreement(s) supported by this RPP will be provided by BARDA. The general objective of this project is to expand domestic sterilization capacity for products or services that are part of the FDA regulated supply chain for sterile injectable vaccines and therapeutics for which supply chain bottlenecks may exist during high demand periods in PHEs. The Government objective is for an industry partner to identify, develop, and qualify new U.S.-based X-ray or dual E-Beam/X-ray sterilization capacity to support USG COVID-19 and future PHE-related vaccine and therapeutic production. Subsequent purchase orders related to the production and supply of critical vaccines and therapeutics that require the use of the sterilization capacity established in relation to this RPP are subject to HHS' delegated Defense Production Act Priority Rating Authorities pursuant to Executive Order 13603 and the Health Resources Priorities and Allocations System.