Solicitation

Notice
Q&A

HT942524Q0047: Procurement of GMP Manufactured QS-21

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Notice ID

Solicitation Type

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Description

The purpose of the Amendment 0002 of Solicitation HT9425-24-Q-0047 is due to the following:1. To provide answers to questions received from industry.2. To provide updates to MECS3. To extend proposal due date to 18 June 20244. To provide Attachments as part of the answers from questions receivedThe copy of the copies of amended solicitation HT9425-24-Q-0047-0002 attached is posted twice and they are the same documents.No more questions will be accepted at this time.

Points of Contact

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Update Details

Subject

Posting Date

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Product or Service Code

NAICS

Place of Performance Zip Code

Place of Performance Address

Walter Reed Army Institute of Research (WRAIR)ROBERT GRANT AVENUE BLDG 503SILVER SPRING MD 20910-7500

Recovery Act

Yes

Contract Information

Contracting Office DoDAAC

Contracting Office Name

Contracting Office Address

808 SCHREIDER ST FORT DETRICK          MD 21702-5014 FORT DETRICK  MD  21702 FORT DETRICK MD 21702 USA

A Material Safety Data Sheet (MSDS) must be attached to offer submissions in accordance with FAR Clause 52.223-3.

Attachments

Name	File/URL	Date	Document Type	Include in Response
B08_Amendment_Solicitation_HT942524Q0047_0002_docx	B08_Amendment_Solicitation_HT942524Q0047_0002_docx.pdf	2024-06-11	Attachment	No
Abucayon_2023_ACS_Omega_8_21016_supplement	Abucayon_2023_ACS_Omega_8_21016_supplement.pdf	2024-06-11	Attachment	No
Abucayon_2023_ACS_Omega_8_21016_UPLC_MS__method_to_quantify_qs_21_adjuvant	Abucayon_2023_ACS_Omega_8_21016_UPLC_MS__method_to_quantify_qs_21_adjuvant.pdf	2024-06-11	Attachment	No
B08_Amendment_Solicitation_HT942524Q0047_0002_docx	B08_Amendment_Solicitation_HT942524Q0047_0002_docx.pdf	2024-06-11	Attachment	No
FDA_Guidance_for_Contract_Mfg_for_drugs_Quality_Agreements_2016	FDA_Guidance_for_Contract_Mfg_for_drugs_Quality_Agreements_2016.pdf	2024-06-11	Attachment	No
QS21_Chemical_Descriptions	QS21_Chemical_Descriptions.docx	2024-06-11	Attachment	No
Quality_Agreement_Template	Quality_Agreement_Template.docx	2024-06-11	Attachment	No
QUALITYAGREEMENT	QUALITYAGREEMENT.pdf	2024-06-11	Attachment	No
Supplier_Quality_Questionnare_05Feb2024_WL_ORA	Supplier_Quality_Questionnare_05Feb2024_WL_ORA.docx	2024-06-11	Attachment	No

Update / Notice

Update / Notice ID	Description	Posted Date	Response Date
0001	The purpose of the amendment to the solicitation is to extend proposal due date to 14 June 2024 while responses are being prepared for questions received.	2024/06/04 14:20 UTC	2024-06-14 10:00 Eastern Standard Time
HT942524Q0047	This is a new requirement for Research and Development requirement for the manufacturing of (minimum of 20,000 dose/lot) of Army Liposome Formulation containing QS-21 (ALFQ) under Current Good Manufacturing Practices (cGMP), in support of Walter Ree	2024/05/08 11:31 UTC	2024-06-07 10:00 Eastern Standard Time