75A5012R00003_AVAT_mAb_RFI_SAM.Final.docx

RFI 75A5012R00003 - AVAT

75A5012R00003_AVAT_mAb_RFI_SAM

Biomedical Advanced Research and Development Authority (BARDA) Administration for Strategic Preparedness & Response (ASPR) Dept of Health and Human Services (HHS)

Request for Information (RFI) and Draft Statement of Objectives (SOO)

Manufacturing Optimization for Filovirus Human Monoclonal Antibodies

Issued: 20 March 2024

Responses Requested by 20 April 2024

Biomedical Advanced Research Development Authority (BARDA) Contracts Management & Acquisition (CMA) 400 7th Street, SW, Washington, DC 20024 MedicalCountermeasures.gov

1.0 Objective

The objective of this Request for Information (RFI) is for BARDA program officials to better refine the requirements for manufacturing optimization for Filovirus Human Monoclonal Antibodies. BARDA is considering using BARDA’s BioMaP-Consortium vehicle (BioMaP) for this project.

The information requested from this RFI will serve as continued market research in support of a potential program under BARDA’s BioMaP-Consortium wherein BARDA would partner with organizations to work towards advancing biomanufacturing technologies. None of the information in this RFI is intended to suggest a particular approach or contract solution.

2.0 Project Scope

This initiative will support the advanced manufacturing development of a monoclonal antibody (mAb) cocktail. A primary aim of this initiative is to identify a high yield, low-cost manufacturing process for the target mAbs that does not impact potency.

The sequence information for the mAbs will be provided to Offerors after award, dependent upon execution of a Material Transfer Agreement (MTA) with the IP holder. The base period will focus on producing high yield cell lines that will support a scalable manufacturing process while maintaining product potency. Multiple offerors are anticipated to be awarded the base period work, and products resulting from that work will then be sent to a CRO of BARDA’s choosing for potency assessment. After assessment, the government will evaluate the products generated in the Base period, using potency and cell line yield as the primary evaluation criteria. The government may then award an option period to select CDMOs (no more than two) for manufacturing optimization. The option period may support optimization of upstream and downstream processes for drug substance production, prioritizing cost of goods and manufacturing as well as supporting proof of concept for manufacturability at a pilot scale (200-2000L); an additional option period may support technology transfer of the manufacturing process to another entity. Final deliverables will include manufacturing reports and a tech transfer report.

3.0 Sources Sought

BARDA is interested in advancing manufacturing development for an already identified monoclonal antibody (mAb) cocktail composed of two mAbs. Work will be focused on the development of this antibody cocktail at a CDMO. BARDA anticipates project awards will be made to multiple Contract Development Manufacturing Organization’s (CDMOs) with the best solution and capability to manufacture the two antibodies.

3.1.1 Specifications/Requirements:

· CDMO will be required to enter into a Joint Material Transfer Agreement (MTA) with BARDA and an IP Holder to obtain mAb sequences and comparability/reference material.

· CDMO with the capabilities to perform the following:

· Establish high yield, clonal cell clines with a preference towards Chinese Hamster Ovary (CHO) expression systems.

· Demonstrate the ability to produce the two mAb cocktail at a scale greater than or equal to 5 liters

· Create Research Cell Bank/Master Cell Bank (cell line generation and initial process development in small batch scale manufacturing processes)

· Perform process optimization of the upstream and downstream manufacturing processes

BARDA encourages experienced specialists to respond for a full or partial solution so we can better understand the current state of the science. Respondents do not have to be a member of the BioMaP consortium vehicle to submit a response for this RFI.

Please submit papers by email to laura.saddison@hhs.gov and erin.greninger@hhs.gov no later than the close of business on April 20, 2024.

This RFI is issued for information and planning purposes only and does not constitute a solicitation. All information received in response to the RFI that is marked as proprietary will be handled accordingly by the Government and ATI. Responses to this RFI are not considered offers and cannot be accepted by BARDA to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI. All information submitted in response to this RFI shall remain with the Government and will not be returned.

4.0 Format:

Respondents are invited to submit responses to any of the questions in Section 5.0. Responses to this RFI should explore the listed questions as well as similar issues to best support the successful advancement of this effort. Additionally, BARDA is grateful for any questions or feedback provided on Attachment #1 – Draft Statement of Objectives (SOO). Attachment #1 feedback is welcome via track changes and/or generally in Section 6.0.

Responses to RFI should include:

Date: [Insert Date of Submission] Title: [Insert descriptive title of project] Point of Contact: [Insert name, organization, email address, phone number]

5.0 RFI Questions:

As part of the RFI response, BARDA is requesting responses to the following questions:

1. Technical questions:

a. Is your company capable of developing optimized cell line expression systems for monoclonal antibodies based on antibody sequence alone? What additional information or reagents would a) be required for or b) assist in your company providing the best product, considering post translational modifications and other factors potentially relevant for expression and potency?

b. What challenges do you foresee with executing the scope of work as described above, focused on maximizing cell line yield and lower cost of goods?

c. What steps would be taken to identify the best cell line for expression of the target antibodies?

d. What average titer (i.e. g/L) does your company achieve for mAb expressing cell lines? Are these cell lines proprietary and, if so, what are the licensing opportunities for the cell lines?

e. What USG investments in monoclonal antibody manufacturing, in general, will help move the field toward a lower cost process? Toward a faster manufacturing process?

f. Are the timelines indicated in the SOO considered reasonable?

g. BARDA intends to require that the MTA with the IP holder must be in place within four months of award. Please comment on appropriateness of this timeline.

h. The government proposes that product generated in the Base period of the award will be sent to a CRO for potency testing. Data generated by the CDMO will be used to determine whether option periods are awarded. Does your organization see challenges with this approach?

2. General questions:

a. Would a requirement to join the BioMaP consortium prevent you from responding to this RRP?

b. Is your CDMO willing and able to enter into a joint Material Transfer Agreement (MTA) with the IP Holder to obtain mAb sequences and comparability/reference material?

c. In one paragraph or less, please describe your CDMO organization’s experience partnering with product developers, in the same or similar capacity as required by this scope of work?

d. Would an Industry Day hosted by BARDA to discuss the requirements of the SOO and a public Q&A session be useful?

e. If offered, would your organization participate in a 1:1 meeting with BARDA?

f. If you are notionally interested in partnering, is there anything that would prevent the response as a partner, i.e., exclusivity, IP or any issue adding a partner to your team?

g. If available, would your organization be interested in participating in a public-facing “Interested Parties Portal” to identify potential partners for this notional opportunity?

h. When this Request for Project Proposals (RPP) solicitation opens, how many days will your organization require to provide a thorough response?

i. Would your organization prefer an Other Transactions Agreement (OTA) over a FAR-based contract for this effort? Please state your reasoning.

6.0 Attachment #1 – Draft Statement of Objectives Feedback:

Please provide general feedback to Attachment #1 here:

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