Amendment 1 12_20_2024.pdf

AMENDMENT #1: RFP 75N95025R00005

The purpose of this Amendment is to:

1) To add the Solicitation attachment entitled “RFP TRND 3 11_27_24 Final_Clean”

2) Provide responses to Questions received as of 12/20/2024.

3) Extend the deadline for submission of questions. Section A.12. of the solicitation is amended as follows:

OFFEROR’S QUESTIONS: Questions must be emailed to the Contract Specialist at michelle.cecilia@nih.gov by 03:00 PM EDT, January 3, 2025. Questions and answers shall be published on SAM.gov as an RFP amendment.

ALL OTHER TERMS AND CONDITIONS REMAIN UNCHANGED

mailto:michelle.cecilia@nih.gov

AMENDMENT 1 – POSTED 12/20/24

Drug Product: Questions and Answers

Q1: Synthetic peptide: 37-amino acid peptide (SPDP) target, do you seek total chemical synthesis? Or are your seeking manufacture the SPDP in E.coli? It seems not clear.

A1: Technical Area 2 concerns “Formulation Development, Manufacture and Analysis of Synthetic Peptides, Oligonucleotides, and Related Drug Products”. Thus, we expect solid phase synthesis of all subject drug products, not production in biological systems (e.g., E.coli).

Q2: I am not sure that the manufacture and analysis of synthetic peptide: 37-amino acid peptide (SPDP) target to be designed and expressed and purified from E. coli with endotoxin removal? This could be the cheapest way for large-scale manufacture down the road? This is our expert, we have done pre-GMP works for both 9 Meters (NC) and BioHybrid Solutions (NC) for the government contracts before.

A2: The drug products under Technical Area 2 are to be chemically synthesized, not expressed and purified from E.coli.

Q3: We are considering to be part of the sub-contractor if needed for:

IV. Anticipated activities considered ancillary to the manufacture and analysis of synthetic peptides, oligonucleotides, and related substances include, but are not limited to, the following:

a. Deliver study reports, including but not limited to weekly status update reports, summary development reports, analytical methods development and qualification/validation protocols and reports, forced degradation study protocols and reports, Master Batch reports, GMP campaign reports, and CMC report in CTD format.

b. Conduct bi-weekly or weekly (as required) project update teleconferences.

c. Perform technology transfer from/to a third party when required.

d. Store non-GMP and GMP lots of RS, DS and DP.

e. Ensure compliance with cGMP.

f. Maintain quality systems to support cGMP activities.

A3: The Government allows Offerors to propose subcontracting arrangements with other vendors. However, a fully responsive proposal should come from the primary Offeror, not from a potential subcontractor. That is, if your company is only seeking to act as a subcontractor in fulfillment of certain tasks, your company should not submit a proposal in response to this RFP.

Rather, you should work with your expected prime contractor to provide them with the necessary technical and workforce, etc. details about your company that they would compile into the full response to the RFP.