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

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HEALTH AND HUMAN SERVICES, DEPARTMENT OF | CENTERS FOR DISEASE CONTROL AND PREVENTION has floated a tender for Notice of Intent to Sole Source - Micron Biomedical - Dissolving Microneedle patch. The project location is USA and the tender is closing on 22 Aug 2024. The tender notice number is 2024-87829, while the TOT Ref Number is 105449264. Bidders can have further information about the Tender and can request the complete Tender document by Registering on the site.

Procurement Summary

Country : USA

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

Deadline : 22 Aug 2024

Other Information

Notice Type : Tender

TOT Ref.No.: 105449264

Document Ref. No. : 2024-87829

Competition : ICB

Financier : Self Financed

Purchaser Ownership : Public

Tender Value : Refer Document

Purchaser's Detail

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Tender Details

Description

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.
Active Contract Opportunity
Notice ID : 2024-87829
Related Notice
Department/Ind. Agency : HEALTH AND HUMAN SERVICES, DEPARTMENT OF
Sub-tier : CENTERS FOR DISEASE CONTROL AND PREVENTION
Office: CDC OFFICE OF ACQUISITION SERVICES
General Information
Contract Opportunity Type: Special Notice (Original)
All Dates/Times are: (UTC-05:00) CENTRAL STANDARD TIME, CHICAGO, USA
Original Published Date: Aug 07, 2024 09:16 am CDT
Original Response Date: Aug 22, 2024 04:00 pm CDT
Inactive Policy: 15 days after response date
Original Inactive Date: Sep 06, 2024
Initiative: None

Classification
Original Set Aside:
Product Service Code: B599 - SPECIAL STUDIES/ANALYSIS- OTHER
NAICS Code: 541690 - Other Scientific and Technical Consulting Services

Place of Performance: Atlanta, GA 30341 USA