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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,... 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, Inc., located at No. 45-1, Guangfu N. Rd., Hukou Township, Hsinchu County 30, Taiwan (R.O.C.) on behalf of NIH, NIAID, LIR. 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. Description of qualifications and experience in procuring biological drugs and dealing with foreign companies. Abbreviations: M: Month DP: Drug Product CoA: Certificate of Analysis GMP: Good Manufacturing Practice Anticipated Period of Performance It is anticipated that an award will be made on or about September 23, 2024. Delivery of supplies will be required as soon as possible following the award. Capability Statement/Information Sought If your organization has the potential capacity to provide, on a brand-name basis, a purchase of GMP-manufactured Monoclonal Antibody UB-421 (100 Liters) that meets the specifications listed above, please provide the following information: 1. Company Information Company name Address Point of contact (name, phone number, email) UEI number Business size and type (e.g., 8(a), HUBZone, Other than Small, etc.) pursuant to the applicable NAICS code 2. Please identify any Best-in-Class contract vehicles, including Government-Wide Acquisition Contracts (GWACs) such as GSA schedule, that your company possesses or is aware of that could support this requirement. If your organization does not provide the products/services under a GWAC, please specify that the availability is OPEN MARKET ONLY. 3. Capability Statement Description of the company’s capabilities and experience in supplying biopharmaceuticals, particularly those manufactured in Taiwan Relevant past performance information, including contract numbers, project descriptions, and customer points of contact Any certifications or qualifications relevant to the requirement 4. Technical Information Detailed information on how the company can meet the product specification and regulatory requirements Any additional information that demonstrates the company’s ability to fulfill the requirement Submission Instructions: Interested businesses who consider themselves qualified to provide the above listed Good Manufacturing Practice-manufactured Monoclonal Antibody one (1) lot of UB-421 (100 Liters) are invited to submit a response to this Sources Sought Notice by August 22, 2024 at 3:00 PM EST. All responses under this Sources Sought Notice shall be emailed to Linda Smith (Linda.smith2@nih.gov) and Hershea Vance at (hershea.vance@nih.gov). Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the 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 response is complete 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. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s)