Amendment #1 - updating the project summary July 18, 2024
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) has a need for a Good Manufacturing Practice (GMP) -manufactured Monoclonal Antibody to provide advanced syntax analysis capabilities. Specifically, NIAID, LIR is seeking a GMP manufactured Monoclonal (UB-421) Antibody that will be administed to people living with HIV (PLWH) carrying multidrug-resistnat virus (MDR). Any proposed monoclonal UB-421 antibody, must be FDA regulated. The antibodies will be used in a LIR clinical trial. Each batch of antibody that is manufactured, must undergo a series of rigorous tests and report data to the FDA to obtain approavl for use in humans.
The final monoclonal antibody drug substance (DS) product must meet the following criteria:
1. Appearance: Clear and colorless solution
2. Protein Concentration: 9.0 to 11.0 mg/mL
3. pH: 6.0 to 7.0
4. Peptide mapping: The profile of the Sample solution corresponds to the profile of the Standard solution
5. Monomeric IgG by SEC: H.M.W NMT 5.0 % Monomeric lgG NLT 95.0%
6. Low molecular weight impurities by L.M.W impurities S 5.0% non-reducin2: CE-SDS
7. Charge variant by IEX: S1/S2: 5-33%; S2/S2: 12-51% S2/S3: 9-23%; S3/S3: 2-10% Other variants: NMT 49%
8. Residual DNA: ≤4 pg per mg protein
9. Protein A: ≤15.0 ng/mg protein
10. CHO HCP: ≤100.0 ng/mg protein
11. rCD4 Binding Assay by ELISA: 80.0-125.0 % binding activity of Reference Standard
12. Bioburden: ≤1 CFU/10 mL
13. Bacterial Endotoxin Test: ≤1 EU/mL
14. Tween 80 concentration: 0.02 % to 0.08 %
15. HIV-1 neutralization assay: 25-150 % relative potency (ICS0) of Reference Standard
16. Provide evidence of FDA approval number
Monoclonal Antibody Drug Product (DP) requirement:
The final Monoclonal Antibody Drug Product (DP) product must meet the following criteria:
1. Appearance: Homogeneous, clear, colorless, and odorless solution
2. Physical testing: (1) Foreign and Particulate Matter: free from particulate matter that can be observed on visual inspection. (2) Container closure testing: rotate the cap by hand to check the compactness and invert bottle for more than 10 seconds to check that there is no leakage or cover off
3. Protein Concentration: 9.0 to11.0 mg/mL
4. pH: 6.0 to 7.0
5. Peptide mapping: The profile of the Sample solution corresponds to the profile of the Standard solution
6. Monomeric IgG by SEC: H.M.W: NMT 5.0% Monomeric lgG NLT 95.0%
7. Low molecular weight impurities by non-reducing CE-SDS: L.M.W: impurities: ≤ 5.0%
8. Charge variant by IEX Sl/S2: 5-33%; S2/S2: 12-51% S2/S3: 9-23%; S3/S3: 2-10%, Other variants: NMT 49%
9. rCD4 Binding Assay by ELISA: 80.0%-125.0% binding activity of Reference Standard,
10. Particulate matter: (1) ~ 10μm particle: NMT 6000 per container (2) > 25um particle: NMT 600 per container
11. Sterility No detectable growth
12. Bacterial Endotoxin Test : ≤ 1 EU/mL
13. Tween 80 concentration 0.02%-0.08%
14. Extraction volume > 10mL.
Anticipated Period of Performance
It is anticipated that an award will be made on or about September 23, 2024. Delivery of equipment will be required as soon as possible.
Capability Statement/Information Sought
If your organization has the potential capacity to provide a GMP-manufactured Monoclonal Antibody which meets the minimum salient characteristics listed above, please provide the following information:
1. Organization name, address, point of contact, email address, website address, telephone number, UEI number
2. Type of business (e.g., 8(a), HUBZone, Other than Small, etc.) pursuant to the applicable NAICS code
3. Identification of any Best-in-Class contract vehicles including Government Wide Acquisition Contracts (GWAC) (e.g., GSA schedule, NITAAC) they may possess or are aware of that would support this possible requirement. If your organization does not provide the products/services under a GWAC, please identify availability as OPEN MARKET ONLY.
4. Tailored capability statement addressing the capability of the instrument to meet NIAID’s minimum salient characteristics. Capability document shall be no more than six pages.
5. Place of manufacture for the GMP-manufactured Monoclonal Antibody and if applicable, any accessories/components.
6. Evidence that the organization is an authorized reseller or manufacturer of the instrument. Only Original Equipment Manufacturer (OEM) products are acceptable.
Submission Instructions
Interested businesses who consider themselves qualified to provide the above listed GMP-manufactured Monoclonal Antibody are invited to submit a response to this Sources Sought Notice by July 25, 2024, at 3:00 PM EST. All responses under this Sources Sought Notice shall be emailed to Hershea Vance at hershea.vance@nih.gov. The response date remains unchanged as a result of this amendment.
Disclamer 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).
