Tender Details

Country: USA
Summary: Notice of Intent to Sole Source - Micron Biomedical - Dissolving Microneedle patch
UST Ref No: 105449264
Deadline: 22 Aug 2024
Financier: Self Financed
Purchaser Ownership: Government
Tender Value: Refer Document
Notice Type: Tender
Document Ref. No.: 2024-87829
Purchaser's Detail:
Login to see full purchaser details. Login to see full purchaser details. Login to see full purchaser details. Login to see full purchaser details. Login to see full purchaser details. Login to see full purchaser details. Login to see full purchaser details. Login to see full purchaser details. Login to see full purchaser details.
Login to see details
Description:
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.
Documents:

If you are registered member, kindly login to view full details of this tender notice:

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

The HEALTH AND HUMAN SERVICES, DEPARTMENT OF | CENTERS FOR DISEASE CONTROL AND PREVENTION, a Government sector organization in USA, has announced a new tender for Notice of Intent to Sole Source - Micron Biomedical - Dissolving Microneedle patch. This tender is published on USARFP under UST Ref No: 105449264 and is categorized as a Tender. Interested and eligible suppliers are invited to participate by reviewing the tender documents and submitting their bids before the deadline on 2024-08-22.

The estimated tender value is Refer Document, and full details, including technical specifications and submission requirements, are provided in the official tender documents. Ensure all submissions meet the criteria outlined to be considered for evaluation.