Good Manufacturing Practice (GMP)-manufactured Monoclonal Antibody

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) copy of the batch record for 100-L GMP manufacturing, provided in PDF format. - One (1) copy of the Certificate of Analysis (CoA) for 100-L GMP Drug Substance (DS), provided in PDF format. - One (1) batch of Drug Product (DP) (approximately 500 vials). - One (1) copy of the batch record for 100-L DP GMP manufacturing, provided in PDF format. - One (1) copy of the CoA of 100-L GMP DP, provided in PDF format. - Seven (7) analytical reports for the long-term DP stability study (1M, 3M, 6M, 9M, 12M, 18M and 24M), provided in PDF format. - Three (3) analytical reports for the accelerated DP stability study (1M, 3M and 6 M), provided in PDF format. - One (1) final report for the DP stability study, provided in PDF format. Abbreviations: M: Month DP: Drug Product CoA: Certificate of Analysis GMP: Good Manufacturing Practice Only one award will be made as a result of this notice. This will be awarded as a firm-fixed price purchase order. The period of performance for full performance is September 23, 2024 - September 24, 2025. The North American Industry Classification (NAICS) code for this acquisition is NAICS: 325412 - Pharmaceutical Preparation Manufacturing which has a size standard of 1,300 Employees. United BioPharma, Inc. is an other than small business. This will be the only notice of the Government's intent to solicit, negotiate, and award to one source to satisfy this requirement. The Government plans to award a contract for this requirement within 19 days of this notice. THIS IS NOT A SOLICITATION FOR COMPETITIVE QUOTATIONS. The Government understands that United BioPharma is the only vendor who can provide the requested monoclonal antibody for NIAID. However, companies that believe they can provide the GMP-manufactured Monoclonal Antibody UB-421 (100 Liters) should submit a capability statement via email to Hershea Vance at Hershea.Vance@Nih.gov by 3:00pm EST on Wednesday, September 20, 2024. A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government. Any responses received by NIAID after this date and exact time specified are late and will not be considered. This notice does not obligate the Government to award a contract or otherwise pay for any information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. For additional information or to submit responses, please contact Hershea Vance, Contract Specialist at Hershea.Vance@Nih.gov