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Request for Solutions (RFS) Lyophilized Pathogen Reduced Cryoprecipitate Prototype Manufacturing Advancement (Lyo-Cryo) Project   2

ID: W900KK-22-9-0011 • Type: Solicitation
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Description

Posted: May 9, 2022, 12:42 p.m. EDT

Please note, Amendment 01 has been issued as of, May 09, 2022. The submission date for all solutions remains unchanged as referenced in the RFS.

The Lyophilized Pathogen Reduced Cryoprecipitate Prototype Manufacturing Advancement (Lyo-Cryo) Project Request for Solutions (RFS) is a solicitation for prototypes. Please note, this RFS is NOT associated with the Cornerstone Consortium and is being issued through a collaborative effort between Industrial Base Analysis and Sustainment (IBAS) program, Program Executive Office (PEO) for Simulation, Training, & Instrumentation (STRI) and Army Contracting Command (ACC) Orlando. The Government will be accepting questions related to the RFS. The Government intends to provide any responses as soon as possible.

Question respondents are advised that the U.S. Government will not pay for any information or administrative costs incurred in the submission of questions to this Draft RFS; all costs associated with question submissions to this RFS will be solely at the respondent's expense.

Questions to this RFS must be submitted to lindsay.r.jaime.civ@army.mil, using Attachment 2 Vendor Questions Form. A closing date for questions will be identified in the RFS.

Please note, the intent of releasing this RFS is to provide notice of an OTA effort under the IBAS program. The RFS is being issued in accordance with 10 U.S. Code 4200.

Notice ID: W900KK-22-9-0011

Posted: April 19, 2022, 9:31 a.m. EDT
Posted: March 29, 2022, 11:58 a.m. EDT
Background
The Lyophilized Pathogen Reduced Cryoprecipitate Prototype Manufacturing Advancement (Lyo-Cryo) Project Request for Solutions (RFS) is a solicitation for prototypes. This RFS is NOT associated with the Cornerstone Consortium and is being issued through a collaborative effort between Industrial Base Analysis and Sustainment (IBAS) program, Program Executive Office (PEO) for Simulation, Training, & Instrumentation (STRI) and Army Contracting Command (ACC) – Orlando. The Government will be accepting questions related to the RFS. The Government intends to provide any responses as soon as possible.

Work Details
The project has an overall development scope that includes increased manufacturing of lyophilized, pathogen reduced plasma cryoprecipitate blood product by establishing a new prototype manufacturing line. The vendor shall deliver a product that meets specific unit specifications including Fibrinogen, Factor VIII, Von WB, Factor XIII, Fibronectin, pH level, and Unit size.

The vendor shall also demonstrate, assess, and verify the current manufacturing capability for lyophilized, pathogen-reduced plasma cryoprecipitate blood product stored in a non-temperature-controlled environment. Additionally, the vendor shall develop a large-scale prototype manufacturing line for lyophilized, pathogen-reduced plasma cryoprecipitate blood products and file for FDA New Drug Approval Biologics License Application (BLA).

Period of Performance
The anticipated delivery schedule aims to complete all Government's full set of requirements within 24 months after award.

Place of Performance
The geographic location(s) for performance will be determined during agreement negotiations.

Overview

Agency
ACC Orlando (ORL) [DoD - USA - AMC - ACC]
Response Deadline
May 13, 2022, 1:00 p.m. EDT Past Due
Posted
March 29, 2022, 11:58 a.m. EDT (updated: May 9, 2022, 12:42 p.m. EDT)
Set Aside
None
NAICS
325413 - In-Vitro Diagnostic Substance Manufacturing
PSC
6910 - Training Aids
Place of Performance
United States
Source
SAM
Current SBA Size Standard
1250 Employees
Est. Level of Competition
Average
On 3/29/22 ACC Orlando issued Solicitation W900KK-22-9-0011 for Request for Solutions (RFS) Lyophilized Pathogen Reduced Cryoprecipitate Prototype Manufacturing Advancement (Lyo-Cryo) Project due 5/13/22. The opportunity was issued full & open with NAICS 325413 and PSC 6910.
Primary Contact
Name
Lindsay Jaime   Profile
Email
lindsay.r.jaime.civ@army.mil
Phone
(321) 235-7763

Secondary Contact

Name
Mark A. Muniz   Profile
Email
mark.a.muniz6.civ@army.mil
Phone
(407) 208-3213

Documents

Posted documents for Solicitation W900KK-22-9-0011

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Additional Details

Source Agency Hierarchy
DEPT OF DEFENSE > DEPT OF THE ARMY > AMC > ACC > ACC-CTRS > ACC-ORL
FPDS Organization Code
2100-W900KK
Source Organization Code
500036903
Last Updated
May 28, 2022
Last Updated By
mark.a.muniz6.civ@mail.mil
Archive Date
May 28, 2022