Notice of Intent to Sole Source - Micron Biomedical - Dissolving Microneedle patch

The objective of this project is to manufacture microneedle (MN) patches to deliver live attenuated rotavirus vaccine for use in an animal toxicology study. A manufacturing process will be implemented to produce MN patches that are suitable for a future pre-clinical trial. As such, appropriate controls will be implemented to meet and/or exceed the requirements described in FDA's Guidance for Industry: Good Laboratory Practice and cGMP for Phase 1 Investigational Drugs. Controls will be developed and implemented for the process , personnel, equipment, facilities, environment, materials/components, packaging/labeling, records, and testing. Also, because the rotavirus antigens are sensitive to heat and other sterilization methods, terminal sterilization is not an option. Therefore, the MN patches will be manufactured under controlled bioburden conditions. Through contamination control methodologies along with aseptic techniques the contractor shall conduct production runs of high quality MN patch vaccines. The MN patch vaccine formulation shall be optimized for stability and potency, and a scalable manufacturing process shall be developed that is compatible with aseptic processing within a cGMP environment. To date, Micron Biomedical has been the only vendor capable of meeting the stringent lab requirements for mass production of these patches.