24-QA Original RFP.pdf

Attachment 24

Q&A Original RFP

Q: Is it a requirement to be able to supply services for every aspect of the RFP or is a “No Bid” section permitted?

A: It is not necessary to bid on all three technical areas. It is entirely acceptable to propose on only one technical area, and that does not put an offeror at a disadvantage. Our expectation is that many vendors specialize in only one or two areas at the most. Each technical area proposed upon is evaluated on its own merits. We expect to make multiple awards within each technical area so that the Government has a roster of qualified vendors to serve the needs of each technical area. See Attachment 7-Additional Technical Proposal Instructions, and Attachment 12-Additional Business Proposal Instructions for additional guidance.

Q: Would an Offeror be allowed to subcontract a DS activity to external vendors rather than execute the activity internally within our own facilities when internal capabilities are limited?

A: The intent of this RFP is to receive proposals from Offerors that fulfill the comprehensive range of requirements detailed within each Technical Area proposed upon. In cases where an Offeror may not be able to fulfill all requirements using purely internal resources, it is acceptable to propose partnering / subcontracting arrangements that would enable the Offeror to complement their own internal expertise and capabilities to provide that comprehensive support. Per the Additional Technical Proposal Instructions (See Attachment 7-Additional Technical Proposal Instructions), “Offerors proposing Subcontracts to perform portions of the Statement of Work should clearly identify the specific tasks for which they plan to utilize subcontractors, as well as the method and level of integration/coordination between the prime Contractor and all proposed Subcontractors, and the expected advantages of such an approach.”

Q: "Subsections 3.A., 3.B., and 3.C. (of Attachment 7) must be complete on their own and include all requested information for that subsection. Subsections may not refer to other subsections for information." Please confirm that the subsections should be complete, but remain within the same Volume document, and not standalone documents.

A: Each Technical Area should be completely addressed within its own section but not as a standalone document.

Q: Wondering if you have a detailed RFP, meaning the chemistry part of the deliverables for this request. All I saw was the general information in the documents. I am looking for specific product or chemical structures, quantities, qualities, timelines, etc.

A: The more specific technical details are to be found in the Sample Task Orders. One Sample Task Order is provided for each Technical Area, and they are to be found in Attachments 4, 5, and 6.

Q: Will you be able to share the current process and chemical structure of the molecule?

A: There is no specific compound structure or detailed, step-by-step synthetic scheme. Please note that an offeror’s response to the Sample Task Order is not meant to contain a highly precise cost estimate directed to a defined molecule / therapeutic candidate per se (e.g., costs of specific raw materials) or to include a fully realized proposed cGMP process. The Technical Evaluation Factors (Section M.), provide more details about how the responses to the Sample Task Orders will be evaluated. In brief, the response will be used to assess the offeror’s understanding of the types of requirements that the Government might have in future task orders, and the overall soundness, feasibility and completeness of the proposed approach. The additional clarifying details should help offerors frame their response and provide a basis for estimating key cost elements (e.g., labor, potential process improvements).

Q: Can the peptide sequence be disclosed? Does the peptide sequence contain any unusual amino acids? Does the peptide require any type of modification, such as cyclization?

A: There is no specific amino acid sequence for the therapeutic candidate noted in Sample Task Order 2, under Technical Area 2 (Synthetic Peptides, Oligonucleotides and Related Drug Substances). The sequence can be assumed to contain no unusual amino acids or required modifications (e.g., cyclization). Generally, Offerors should consider the presence of D-amino acids, common homo-amino acids (addition of a methylene group to the alpha-carbon of an amino acid), and the presence of several hydrophobic amino acids in sequence.

The Sample Task Order within a given Technical Area is meant to serve as an example of the type of requirements that the Government might have in future, specific task orders under the wider umbrella. The Technical Evaluation Factors (Section M) will provide more details about how the overall response will be evaluated. In brief, the response will be used to assess the Offeror’s understanding of the types of requirements that the Government might have in future task orders, and the overall soundness, feasibility and completeness of the proposed approach.

Q: We are interested in Technical Area 1, but we typically only focus on small molecules that are classified as amino acid derivatives. Does this small molecule represent an amino acid or is this unclear now?

A: The small molecule compound referred to in Sample Task Order 1 is not an amino acid or amino acid derivative. Task orders related to amino acid derivatives are expected to be issued under

Technical Area 2 (Process Development, Manufacture and Analysis of Synthetic Peptides, Oligonucleotides and Related Drug Substances). It is less likely that task orders issued under Technical Area 1 (Process Development, Manufacture and Analysis of Small Molecule Drug Substances) would be related to amino acid derivatives.

Q: Is this RFP open to viral vector production?

A: Yes. Viral vector production is encompassed by Technical Area 3 (Process Development, Manufacture and Analysis of Biopharmaceutical Drug Substances).

Q: We have the capabilities to support both mammalian and microbial development and manufacturing programs, but the requirements of the two expression systems differ. Should we focus our bid on one or the other? If both, I think we’d be looking at two separate proposals. Is that acceptable?

A: As indicated in Technical Area 3 (Biopharmaceutical Drug Substances), the Government anticipates activities in any of the named areas, including, but not limited to, development of mammalian cells lines and microbial strains. As such, Offerors should provide information for any relevant types of systems with which they have expertise within the single Technical Area response.

The Additional Technical Proposal Instructions (See Attachment 7-Additional Technical Proposal Instructions) provide details as to how an Offeror’s proposal should be structured. In brief, an Offeror should seek to convey the breadth and depth of their capability to support the range of activities noted in the Statement of Work for any Technical Areas proposed upon, in as efficient and succinct a manner as possible within the single response. The Technical Evaluation Factors (Section M) provide details about how the overall response will be evaluated. In brief, the response will be used to assess the Offeror’s understanding of the types of requirements that the Government might have in future task orders, and the overall soundness, feasibility and completeness of the proposed approach.

Q: If microbial expression is preferred, should we focus our bid on E. coli, Pichia, or some other microbial expression system?

A: The Government is interested in a range of potential expression systems, as future task orders may be served better by some expression technologies over others. An Offeror should seek to convey the breadth and depth of their capability to support the range of activities noted in the Statement of Work, highlighting the key tools and technologies to which they have access that enable successful performance of said activities.

Q: Should we focus our bid on a mAb? Fc-fusion? Complex recombinant? Molecule type will have a large impact on what the overall bid will look like.

A: Technical Area 3 encompasses a range of potential biopharmaceutical drug substances of interest, inclusive of proteins, antibodies, cell-based therapies and viral vectors for gene therapy.

For the purposes of developing the overall Technical Proposal, Offerors should provide information for the breadth of modalities with which they have expertise within the single Technical Area response. The Sample Task Order provides an example of the type of requirements that the Government might have in future, specific task orders under the wider umbrella.

The Technical Evaluation Factors (Section M) provide more details about how the overall response will be evaluated. In brief, the response will be used to assess the Offeror’s understanding of the types of requirements that the Government might have in future task orders, and the overall soundness, feasibility and completeness of the proposed approach.