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IntestiCult Organoid Growth Medium (Human)

Waiver type - Procurement: Nonavailability

Agency: NATIONAL INSTITUTES OF HEALTH (7529) • Product Service Code (PSC) : 6509 | Last Modified: 07/19/2024

Procurement Summary

The Laboratory of Infectious Diseases (LID) has a long history of vaccine development and identification of new agents of viral diseases. LID is noted for undertaking high-risk, high-re ward programs that require extraordinary time and resource commitments, such as programs to develop vaccines for viral hepatitis, severe childhood respiratory diseases, viral gastroenteritis, flaviviruses, and herpes viruses. Within the LID is the Caliciviruses Section focus on the role of human caliciviruses inhuman disease, with a focus on the development of prevention and control strategies for the noroviruses. The Caliciviruses Section requires a IntestiCult Organoid Growth Medium (Human), which is a cell culture medium for establishment and maintenance of human intestinal organoids. The IntestiCult Organoid Growth Medium (OGM) is a complete growth medium optimized for human intestinal organoids. It includes all necessary components for organoid culture, such as growth factors and supplements, eliminating the need for additional additives. This medium provides a robust environment for stem cell development, ensuring consistent and reproducible results, which are essential for reliable experimental outcomes. With this complete medium formulation and optimized protocol the lab can derive organoids from human intestinal crypts. Organoid growth across donor samples, including those that are other wise difficult to grow, is enabled by an enriched stem cell population. Organoids grown in IntestiCult Organoid Growth Medium (Human). incorporate a functional lumenen closed by a polarized intestinal epithelial cell layer and, for versatile modeling applications, can be further differentiated in 3D or in 2D as submerged monolayers or air-liquid interface (ALI) cultures using IntestiCult Organoid Differentiation Medium(Human). The mission need the item(s) are intended to satisfy include obtaining reference laboratory-quality results from the IntestiCult Organoid Growth Medium(Human). By using the application the lab can study the development and function of intestinal epithelium, modeling intestinal diseases, and screening molecules for both efficacy and toxicity in an intestinal model. Intestinal organoid cultures will also be used for investigation of adult stem cell properties and for regenerative therapy approaches. This is necessary in the lab’s experimentation.

Waiver Rationale Summary

Based on the above market research findings and results from the Sources Sought, no acceptable domestically manufactured products that meet the government needs that mined, produces, or manufactured in the United States. Two domestically manufactured was submitted for evaluation, but it was found unacceptable. A foreign manufactured was found that meets the needs of the Government.

Did / Will the solicitation include one of the standard BAA provisions announcing the agency’s intention to provide a price preference for domestic end products and construction material?

Yes

Was a sources sought or Request for Information issued?

Yes

OMB Determination

Consistent with Policy

Product

DRUGS AND BIOLOGICALS, VETERINARY USE

NAICS

325414 - Biological Product (except Diagnostic) Manufacturing

Date Submitted

07/17/2024

Procurement Instrument Identifier (PIID)

Solicitation ID

N/A

Procurement Stage

Pre-solicitation

Expected Maximum Duration of the Proposed Waiver

0 - 6 months

Waiver Coverage

Individual Waiver

Funding Agency

NATIONAL INSTITUTES OF HEALTH