Notice of Intent to Sole Source - Micron Biomedical - Dissolving Microneedle patch
Closed Special Notice Posted
- Solicitation number
- 2024-87829
- Agency
-
CDC Office of Acquisition Services
Centers for Disease Control and Prevention, Department of Health and Human Services
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 541690 Other Scientific and Technical Consulting Services
- PSC
- B599 Special Studies/Analysis- Other
- Place of performance
- Atlanta, Georgia 30341, United States
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
This Special Notice from the Department of Health and Human Services Centers for Disease Control and Prevention Office of Acquisition Services announces the agency's intent to sole source a contract to Micron Biomedical for the manufacturing of microneedle (MN) patches to deliver live attenuated rotavirus vaccine. The purpose is to produce MN patches suitable for use in an animal toxicology study and future pre-clinical trial.
The notice states that Micron Biomedical has been the only vendor capable of meeting the stringent lab requirements for mass production of these patches. The key requirements include implementing appropriate controls to meet or exceed FDA's guidance for Good Laboratory Practice and cGMP for Phase 1 Investigational Drugs. Since the rotavirus antigens are heat sensitive, the patches will be manufactured under controlled bioburden conditions using contamination control methodologies and aseptic techniques. The solicitation has a due date of August 22, 2024, and the NAICS code is 541690 - Other Scientific and Technical Consulting Services.
Notice text
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.
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