Good Manufacturing Practice (GMP)-manufactured Monoclonal Antibody Tender, USA - 107154612

Procurement Summary

Country : USA

Summary : Good Manufacturing Practice (GMP)-manufactured Monoclonal Antibody

Deadline : 20 Sep 2024

Other Information

Notice Type : Tender

TOT Ref.No.: 107154612

Document Ref. No. : NOI-NIAID-24-2226773

Competition : ICB

Financier : Self Financed

Purchaser Ownership : Public

Tender Value : Refer Document

Purchaser's Detail

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Tender Details

Description

THIS IS A NOTICE OF INTENT AND NOT A REQUEST FOR QUOTATIONS

This notice is published in accordance with Federal Acquisition Regulation (FAR) 5.101(a)(1) requiring the dissemination of information regarding proposed contract actions. This is a Notice of Intent to award a sole source, firm-fixed price purchase order under the authority of 41 U.S.C. 1901, as implemented by FAR 13.106-1(b)(2) and 13.501(a) - Only One Responsible Source and No Other Supplies or Service Will Satisfy Agency Requirements and is not a request for competitive proposals.

The National Institute of Allergy and Infectious Diseases (NIAID), intends to negotiate on a sole source basis with United BioPharma, Inc., located at No. 45-1, Guangfu N. Rd., Hukou Township, Hsinchu County 30, Taiwan (R.O.C.) on an other than full and open competition basis for the one (1) lot of Good Manufacturing Practice (GMP)-manufactured Monoclonal Antibody UB-421 (100 Liters). 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.

The 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.

The required specifications are as follows:• One (1) ...
Active Contract Opportunity
Notice ID : NOI-NIAID-24-2226773
Related Notice : NIAID-SS-24-2226773
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: Presolicitation (Original)
All Dates/Times are: (UTC-04:00) EASTERN STANDARD TIME, NEW YORK, USA
Original Published Date: Sep 12, 2024 05:22 pm EDT
Original Response Date: Sep 20, 2024 03:00 pm EDT
Inactive Policy: 15 days after response date
Original Inactive Date: Oct 05, 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