Acquisition of Good Manufacturing Practice (GMP) -manufactured UB-421 (Anti-CD4 Monoclonal... Tender

Procurement Summary

Country : USA

Summary : Acquisition of Good Manufacturing Practice (GMP) -manufactured UB-421 (Anti-CD4 Monoclonal Antibody) from United BioPharma, Inc. - Brand Name Only.

Deadline : 22 Aug 2024

Other Information

Notice Type : Tender

TOT Ref.No.: 105841877

Document Ref. No. : NIAID-SS-24-2226773-2

Competition : ICB

Financier : Self Financed

Purchaser Ownership : Public

Tender Value : Refer Document

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Tender Details

Description

Title: Acquisition of Good Manufacturing Practice (GMP) -manufactured UB-421 (Anti-CD4 Monoclonal Antibody) from United BioPharma, Inc. - Brand Name Only.

ID: NIAID-SS-24-2226773

Post Date: August 15, 2024

Response Date: August 22, 2024

Classification Code: 6505 - Drug and Biologicals

NAICS: 325412 - Pharmaceutical Preparation Manufacturing



Introduction

This is a Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources to perform a potential requirement.

Project Summary

The National Institute of Allergy and Infectious Diseases (NIAID), Laboratory of Immunoregulation (LIR) is conducting an ongoing clinical trial titled “A trial of anti-CD4 antibody UB-421 in combination with optimized background antiretroviral therapy in patients with multidrug-resistant HIV-1 infection.” Currently, the NIH, NIAID, LIR is treating patients harboring multidrug-resistant (MDR) HIV at the NIH Clinical Center with UB-421, a monoclonal antibody used to treat individuals living with HIV (PLWH) carrying MDR virus. This study is associated with Institutional Review Board (IRB) protocols #IRB001672 and IRB001927 and is conducted under an expanded access program approved by the Food and Drug Administration under Investigational New Drug (IND) applications #169181 and 166203.

United BioPharma, located in Taiwan, is the patent holder and manufacturer for UB-421, and the only company that possesses the cell line necessary for its production. As such, United BioPharma is the only known source to produce this drug.

NIAID, LIR has a requirement to purchase one (1) lot of Good Manufacturing Practice (GMP)-manufactured Monoclonal Antibody UB-421 (100 Liters) on a brand-name basis, NIAID, LIR is seeking sources capable of procuring this monoclonal antibody from United BioPharma, ...
Active Contract Opportunity
Notice ID : NIAID-SS-24-2226773-2
Related Notice
Department/Ind. Agency : HEALTH AND HUMAN SERVICES, DEPARTMENT OF
Sub-tier : NATIONAL INSTITUTES OF HEALTH
Office: NATIONAL INSTITUTES OF HEALTH NIAID
General Information
Contract Opportunity Type: Sources Sought (Original)
All Dates/Times are: (UTC-04:00) EASTERN STANDARD TIME, NEW YORK, USA
Original Published Date: Aug 15, 2024 05:31 pm EDT
Original Response Date: Aug 22, 2024 03:00 pm EDT
Inactive Policy: 15 days after response date
Original Inactive Date: Sep 06, 2024
Initiative: None

Classification
Original Set Aside:
Product Service Code: 6505 - DRUGS AND BIOLOGICALS
NAICS Code: 325412 - Pharmaceutical Preparation Manufacturing

Place of Performance: Bethesda, MD 20817 USA

Documents

 Tender Notice