A02 RFI-GMP Manufactured QS-21 14 Mar 24.pdf

REQUEST FOR INFORMATION (RFI)

1.0 RFI TITLE: Procurement of Good Manufacturing Practice (GMP) QS-21

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

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

4.0 SUBJECT: WRAIR is conducting market research to determine whether a commercial solution for the manufacturing and delivery of QS-21 which denotes its source Quillaja saponaria and number 21 as its identity in the reverse phase high performance liquid chromatograph (RP-HPLC). The code QS21 is also used. The form of the QS-21 shall be a lyophilized powder.

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:

Product Description:

• QS-21: QS denotes its source Quillaja saponaria and number 21 as its identity in the reverse phase high performance liquid chromatograph (RP-HPLC). The code QS21 is also used. The form of the QS-21 shall be a lyophilized powder.

• Quantity required: 750 mg

• Product manufacturing requirements: The product shall be manufactured under current Good

Manufacturing Practice (cGMP) conditions in compliance with 21 CFR part 210 and 211. The vendor shall answer questions pertaining to the quality of manufacturing, accommodate an onsite audit and enter into a quality agreement with the Office of Regulatory Affairs (ORA) and the Walter Reed Army Institute of Research (WRAIR). The manufacturing details shall be provided to ORA/WRAIR for inclusion in the Army Liposome Formulation with QS-21 saponin (ALFQ) Master File on file with the Food and Drug Administration (FDA). Alternatively, the vendor shall provide a letter of cross-reference to their QS-21 Master File on file with the FDA. A sample of the same lot of QS-21 shall be tested at Laboratory of Adjuvant and Antigen Research (LAAR)/WRAIR to ensure that the QS-21 meets the acceptance criteria stated below.

• Product component details required: The QS-21 shall meet the specifications described below. In addition, the QS-21 shall be placed on a stability plan of a minimum of two years. The stability data shall be provided or included in the vendor’s master file.

Table 1. Specifications for GMP QS-21 as stated in the below table.

DETERMINATION PROPOSED

SPECIFICATION

PROCEDURE Site/Responsibility

Purity (Conc.) – LC-MS/MS Total QS-21 (QS21-1, QS21-2, QS21-R1, QS21-R2)

≥ 90.0 % UPLC-MS/MS LAAR

QS21-1 (relative to other isomers) ≥ 80.0 % UPLC-MS/MS LAAR Purity (Area %) – HPLC QS-21a (main peak) and QS-21b QS-21 group (RRT 0.80 - RRT 1.05)

≥ 90.0 % ≥ 90.0 %

HPLC Vendor

Impurity/Degradant

QS21-HP ≤ 5.0% UPLC-MS/MS LAAR

Characteristics Appearance White Soft Powder Visual

Inspection Vendor/LAAR

Identification Identity RT and MW correspond to reference

UPLC-MS/MS LAAR

Infrared Absorption Spectrophotometry

Spectrum corresponds to reference

USP<197> Vendor

Tests Water (%) ≤ 5.0 Ph. Eur.2.5.32.;

USP<921>

Vendor

Sulphated Ash For information only. Ph. Eur.2.4.14.;

USP<281>

Vendor

Heavy Metals (ppm)

- Arsenic

- Lead

- Cadmium

- Mercury

≤ 1.5 ≤ 40 ≤ 0.2 ≤ 0.3

Ph. Eur.;

2.4.20.

Vendor

Acetic Acid Content (%) ≤ 0.5 HPLC Vendor Residual Solvents (ppm) Vendor

- Methanol

- Acetonitrile

- Dichloromethane

≤ 3000 ≤ 410 ≤ 600

GC

-TAMC

-TYMC

-Bile-tolerant Gram-Negative Bacteria -Escherichia coli (/0.1 g) -Salmonella (/0.1 g) -Pseudomonas aeruginosa (/0.1 g) -Staphylococcus aureus (/0.1 g)

≤ 200 ≤ 20 Absent Absent Absent Absent Absent

Ph.Eur.2.6.12;

2.6.13;

USP<61>,

<62> Ph.Eur.2.6.12;

2.6.13;

USP<61>,

<62>

Ph.Eur.2.6.13;

USP<62>

Ph.Eur.2.6.13;

USP<62>

Ph.Eur.2.6.13;

USP<62>

Ph.Eur.2.6.13;

USP<62>

Bacterial Endotoxin (UI/mg) < 0.4 Ph.Eur.2.6.14;

USP<85>

Vendor

Potential Impurities ≤ 1. 0 ≤ 5.0 (Total)

UPLC Vendor

Specific Delivery Requirements:

• Packaging requirements: QS-21 shall be delivered in at minimum of two different containers to facilitate the manufacture of 2 lots of ALFQ. The container shall be compatible with QS-21 preferably type 1 glass.

The QS-21 shall be shipped under temperature-controlled conditions with 2 temperature monitors.

The above is for information purposes only for response to the RFI.

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 the RFI response shall be: “Procurement of GMP MANUFACTURED QS-21”. 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. Discuss the respondent’s ability to meet the following:

A. Quantity required: 750 mg

B. Ability to meet specific requirements

C. Specific Delivery Requirements:

• Packaging requirements: QS-21 shall be delivered in at minimum of two different containers to facilitate the manufacture of 2 lots of ALFQ. The container shall be compatible with QS-21 preferably type 1 glass.

The QS-21 shall be shipped under temperature-controlled conditions with 2 temperature monitors.

• Delivery location:

Walter Reed Army Institute of Research (WRAIR) Pilot Bioproduction Facility (PBF) Forest Glen Annex, Building 501 Silver Spring, MD 20910

Please note that responses are due no later than 1200 PM ET, 22 March 2024. The preferred method of submission is via email. The point of contact for this action is Nathaniel Reus, Contract Specialist at nathaniel.a.reus.civ@health.mil

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 Nathaniel Reus, Contract Specialist at nathaniel.a.reus.civ@health.mil no later than the 1200 PM ET on 22 March 2024.

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.

Question Answer 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) mailto:nathaniel.a.reus.civ@health.mil mailto:nathaniel.a.reus.civ@health.mil

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

Has this item of supply been sold, in substantial quantities in the commercial marketplace?