SOURCES SOUGHT
Q -- 3.5 kg GMP Lot of sPIF
- Notice Date
- 5/7/2018
- Notice Type
- Sources Sought
- NAICS
- 325411
— Medicinal and Botanical Manufacturing
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, 6001 Executive Boulevard, Room 4211, MSC 9559, Bethesda, Maryland, 20892-9559, United States
- ZIP Code
- 20892-9559
- Solicitation Number
- NIHDA201800195
- Archive Date
- 5/31/2018
- Point of Contact
- Jeffrey Schmidt, Phone: (301) 402-1488
- E-Mail Address
-
schmidtjr@mail.nih.gov
(schmidtjr@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. Please note that to qualify as an eligible small business for purposes of a small business set-aside, at least 50% of the cost of contract performance incurred for personnel must be expended for employees of the small business awardee (see FAR 52.219-14 Limitations on Subcontracting). Purpose and Objectives The Bridging Interventional Development Gaps (BrIDGs) program at the National Center for Advancing Translational Sciences (NCATS), National Institutes of Health (NIH) assists researchers in advancing promising therapeutic agents through late-stage pre-clinical development toward an Investigational New Drug (IND) application and clinical testing. BrIDGs is currently collaborating with BioIncept to develop Synthetic Preimplantation Fact (sPIF) as a potential treatment for Graft-Versus-Host Disease (GVHD). The purpose of this contract is for BrIDGs to acquire an additional 3.5 kg (on net peptide basis) of cGMP sPIF to allow for additional studies to be conducted, and to conduct a three year stability study of the cGMP batch. Background Information Multiple cGMP lots of sPIF acetate have been acquired by BrIDGs and BioIncept. The sPIF structure is: H-Met1-Val-Arg-Ile-Lys5-Pro-Gly-Ser-Ala-Asn10-Lys-Pro-Ser-Asp-Asp15-OH The counter ion is acetate. Project Requirements In their Capability Statement, respondents shall address the following general requirement: 1.Because multiple cGMP lots of sPIF acetate have been previously acquired, the contractor shall have 3.5 kg of GMP sPIF available or shall be able to manufacture 3.5 kg (on net peptide basis) cGMP lot of sPIF peptide. If the contractor intends to manufacture 3.5 kg GMP lot of sPIF, the Contractor must have prior experience with manufacturing GMP sPIF on a kilogram scale or multi-hundred gram scale and must have an established manufacturing process and qualified analytical methods. These requirements are included to ensure continuity of science; because some of the prior lots of GMP sPIF have been used in toxicology studies and clinical studies, an impurity profile should be similar to the impurity profile of the previous lot (lot no. 2K13043). The Certificate of Analysis (COA) for lot 2K13043 is provided as an attachment to the solicitation. The HPLC method used for lot 2K13043 can be provided on request. In their Capability Statements, respondents shall address the following specific requirements: 2.The Contractor shall deliver a 3.5 kg (on net peptide basis) cGMP lot of sPIF peptide. Respondents shall comment on whether the 3.5 kg GMP lot of sPIF can be delivered as a single batch or has to be delivered in multiple batches. Respondents that propose to manufacture the 3.5 kg GMP lot of sPIF, the Respondents shall comment on whether the facility that will be used to manufacture the batch is the same one that manufactured the previous batch-this is the Government's preferred option. 3.The Contractor shall deliver a QA-approved Certificate of Analysis for the GMP batch. 4.The GMP batch shall be released to the specifications established by the previously acquired cGMP lots of sPIF acetate. 5.The Contractor shall issue a CMC report in CTD format. If a prior CMC report exists, updating with information from the 3.5 kg batch is acceptable. 6.The Contractor shall conduct a three-year stability study of the GMP batch of sPIF peptide per ICH guidelines, using a validated stability-indicating HPLC method and the material from the GMP batch, and deliver a final report describing these studies. The Contractor shall monitor the stability of sPIF peptide for purity, impurities (report total and individual impurities), appearance, identity and residual water at freezer temperature (-20 °C ± 5 °C) at 0, 3, 6, 9, 12, 18, 24 and 36 months, and at 25 °C ± 2 °C/60% RH ± 5% RH at 0, 1, 3 and 6 months. Respondents shall describe in their proposal the container system used for packaging the stability samples and how the samples are to be handled to maintain their integrity. Anticipated Period of Performance The Government anticipates a period of performance of September 2018 - March 2022. Other Important Considerations Work performed under this program must be conducted in accordance with Current Good Manufacturing Practices regulations (cGMPs) and, as appropriate, Good Laboratory Practice regulations. In addition, data and documentation generated under this program must be prepared in a form acceptable to the FDA for inclusion in a Drug Master File (DMF), IND application, or New Drug Application (NDA). Required Information All capability statements must provide the following: (1) DUNS number; (2) organization name; (3) organization address; (4) point of contact; (5) point of contact title, address, telephone, and email address; and (6) size and type of business (e.g., 8(a), HUBZone, etc.) pursuant the applicable NAICS code. Submission Instructions and Due Date Written capability statements must be SUBMITTED NO LATER THAN WEDNESDAY, MAY 16, 2018 to the below Contracting Office Address, Attn: Jeffrey Schmidt. Electronic capability statements will be accepted by the primary point of contact. 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).
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- Record
- SN04912828-W 20180509/180507230619-0795da7d58e786ad66bf03a615b72879 (fbodaily.com)
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