W81XWH-21-RFI-TJK1.docx

W81XWH-21-RFI-TJK1

REQUEST FOR INFORMATION (RFI)

1.0 RFI TITLE: CURRENT GOOD MANUFACTURING PROCESS (CGMP) MANUFACTURING OF 100,000 DOSES OF ALFQ FOR PHASE 2B/3 CLINICAL TRIALS AND THE CAPABILITY TO MANUFACTURE FOR A COMMERCIALLY LICENSED VACCINE

2.0 AGENCY: Walter Reed Army Institute of Research (WRAIR)

3.0 LOCATION: 503 Robert Grant Avenue, Silver Spring, Maryland 20910

4.0 SUBJECT: The Walter Reed Army Institute of Research is conducting market research to determine whether a commercial solution can be provided to meet requirements for cGMP manufacturing of 100,000 doses (minimum of 20,000 doses/lot) of ALFQ for Phase 2B/3 clinical trials and the capability to manufacture for a commercially licensed vaccine. This market research may also assist with the further development and/or refinement of the requirements.

5.0 DISCLAIMER: This is an RFI as defined in FAR 15.201(e) to ascertain whether a commercial item exists that provides the capabilities described herein.

This RFI is issued solely for information and planning purposes and does not constitute a solicitation. Neither unsolicited proposals nor any other kind of offers will be considered in response to this RFI. Responses to this notice are not offers and will not be accepted by the Government to form a binding contract. In keeping with the standards of FAR Part 10, the Government may request additional information from respondents. Respondents are solely responsible for all expenses associated with responding to this RFI or any follow-up information request. All information received in response to this RFI or any follow-up information request that is marked Proprietary will be handled accordingly. Responses to the RFI will not be returned. At this time, questions concerning the composition and requirements for a future request for proposal will not be entertained.

6.0 DESCRIPTION: WRAIR has a requirement to manufacture 100,000 doses (minimum of 20,000 doses/lot) of ALFQ under cGMP conditions as part of COVID-19 vaccine development program. The Government’s Operation Warp Speed (OWS) aims to deliver millions of doses of safe and effective vaccines. In response to OWS, the Government requires partners that can cGMP manufacture and release thousands of doses of ALFQ and have capabilities to scale up the manufacturing to millions of doses. The Government requires partners to cGMP manufacture 100,000 doses (minimum of 20,000 doses/lot) of ALFQ in compliance with 21 CFR Part 210 and 211.

Studies Chemistry, Manufacturing, and Controls Information. In addition, the manufacturing of ALFQ preferably should be compliant with relevant MHRA and EMA regulations and guidance.

ALFQ is an adjuvant formulation composed of ALF55 drug substance (DS), QS-21, and Sorensen’s Phosphate Buffer for which the Army owns a patent (US Patent: US10434167B2). GMP-grade lipid components and QS-21, and USP-grade excipients can be procured commercially. ALFQ has a molar ratio of approximately DMPC: cholesterol: DPMG:3D-PHAD®: QS-21 at 9:12.2:1:0.11:0.05. The ALF55 DS is an Army Liposome Formulation (ALF) with monophosphoryl lipid A and 55% cholesterol. The lipid assembly contains DMPC, cholesterol, DMPG, and 3D-PHAD® in a molar ratio of 9:12.2:1:0.11 (DMPC: cholesterol: DMPG:3D-PHAD®). The ALF55 DS has a particle size distribution of 30–150 nm while the ALFQ drug product (DP) has a polydisperse size distribution ranging from nm to μm. The previous lot of ALF55 DS was manufactured by lipid deposition method. Other scalable processes for the manufacturing of ALF55 DS can be proposed.

The purpose of this RFI is to solicit information on the availability or developmental status of:

•Preparation of liposomes at large scale capacity •Analytical testing to evaluate the safety, quality, identity, and purity of the ALFQ DP

· Develop qualified and validated analytical assays for testing and monitoring of the ALF 55 DS and ALFQ DP •Liquid Chromatography with tandem mass spectrometry or other analytical methods that can determine the quantity of lipid components, QS-21, and degradation products of ALFQ •Develop qualified and validated assays for particle size characterization of ALFQ

· Implement, qualify, and validate Army developed red blood cell lysis assay for the measurement of free QS21 •As applicable, compliance with the FDA, and preferably MHRA and EMA regulations including facility registration •List of liposomal formulations and drugs if any registered at the said facility

Industry partners may provide information on individual aspects of these requirements as partnering is encouraged to meet the total desired requirements.

7.0 SUBMISSION INSTRUCTIONS: Responses from all capable and qualified sources are encouraged to respond to this request. The subject header of the email for submission of questions and/or the RFI response shall be: “CGMP MANUFACTURING OF ALFQ”. All information regarding capabilities statements or any other proprietary information relative to this RFI shall be marked appropriately.

White papers should adhere to the following formatting and outline instructions:

1. All submissions shall be made electronically and be in one of the following formats: Microsoft Word or Adobe PDF. There is a 20-page limit.

2. Cover Page (1 page)

A. Title

B. Organization

C. Respondent’s technical and administrative points of contact (names, addresses, phone numbers, and email addresses)

D. Topic area(s) addressed

3. Completed Attachment 1

4. Discuss the respondent’s ability to meet the following:

A. Preparation of liposomes at large scale capacity and capabilities to make liposomal formulations.

i. Ability to receive non-sterile raw materials for the manufacture of bulk liposome DS.

ii. Ability and capacity for cGMP manufacturing of bulk liposome DS, and performance of in process controls.

iii. Ability to filter bulk liposome DS and QS-21 under sterile conditions.

iv. Ability and capacity for sterile filtration of bulk liposome DS and QS-21 and aseptic fill-finish of the ALFQ DP in 2 or 3 ml vials.

v. Ability and capacity to perform analytical testing for the release DS and DP.

vi. Accessibility to analytical methods available to determine the quantity of lipid components, QS-21, and degradation products of ALFQ.

vii. Ability and capacity to perform analytical testing for the long-term stability of DS and DP, as well as accelerated stability and stress testing.

viii. Synopsis of any relevant experience with the FDA regulations such as:

a. Aseptic process validation

b. The specific procedure(s) for the aseptic manufacturing of liposomal DPs and the methods for controlling and monitoring the process.

c. The Master Production Records (including process controls), as appropriate

d. Details on personnel qualified and trained to implement the aseptic manufacturing process.

e. FDA submissions / marketing authorizations (e.g., NDA, BLA, MAA), status of facility registration, product listings, and any recent inspections and results.

ix. Shelf life (in years) of final products supported by stability studies for similar or comparable liposome DPs

x. Estimated costs per vial of ALFQ DP (estimate for ii., estimate for iii., & estimate for iv-vii)

xi. Any associated intellectual property rights or patent coverage

B. Ability to ship ALFQ DP vials to Government facilities after completing the aseptic manufacturing process

C. Provide information related to the company’s quality systems

D. Provide information related to the company’s registration and listing with the FDA

E. System Description

i. A brief description of the proposed method

F. Cost

i. Provide the Rough Order of Magnitude (ROM) cost estimate (if able to represent in $$/vial)

G. Schedule

i. Estimated timeline/schedule for meeting manufacturing capacity

ii. Estimated timeline/schedule for aseptic manufacturing process, sterile fill-finish, DP release, review and approval of CMC documentation and quality-related documents, and initiation of stability testing (receipt to sterilization to shipment back to Government facility)

Please note that responses are due no later than 1200 PM ET, 23 November 2020. The preferred method of submission is via email. The point of contact for this action is Timothy Kelly, Contract Specialist. Only electronic responses are requested. No evaluation letters and/or results will be issued to the respondents. At this time no solicitation exists; therefore, please do not request a copy of the solicitation. NO PHONE CALLS PLEASE. It is the responsibility of any potential offeror to monitor this site for the release of any solicitation or synopsis.

9.0 SUBMISSION CONTACT INFORMATION: Interested entities shall forward submissions to Timothy Kelly at timothy.j.kelly169.civ@mail.mil no later than the 1200 PM ET on 23 November 2020. Telephonic communication will not be considered as submission nor receive response.

Responses shall be submitted via e-mail only. The font shall be Times New Roman, size 12, single space. All submissions become Government property and will not be returned.

10.0 REQUIRED INFORMATION: Fill in the below table when responding to this RFI.

RFI Number

Company Name

Company Address

Point of Contact

Phone Number

E-mail Address

Tax Identification Number (TIN)

CAGE Code

DUNS Number

Company Web Page

Company Location(s)

Company is / is not a Small Business

Company is / is not SAM Registered

Other Socio-Economic Classifications (e.g. 8(a), HUB Zone, Woman-Owned, Veteran-Owned, Service- Disabled Veteran-Owned)

If 8(a), date that the company graduates from the program