Ambr 250 High Throughput Bioreactor System
ID: HT942525Q0036Type: Presolicitation
Overview

Buyer

DEPT OF DEFENSEDEFENSE HEALTH AGENCY (DHA)ARMY MED RES ACQ ACTIVITYFORT DETRICK, MD, 21702, USA

NAICS

Analytical Laboratory Instrument Manufacturing (334516)

PSC

LABORATORY EQUIPMENT AND SUPPLIES (6640)

Original Source

https://sam.gov/opp/f90037f4d22d49e3bbcfc6764f950951/view
Timeline
  1. 1
    Posted Mar 25, 2025, 12:00 AM UTC
  2. 2
    Updated Mar 25, 2025, 12:00 AM UTC
  3. 3
    Due Not available
Description

The Department of Defense, through the Defense Health Agency, is seeking to procure an Ambr 250 High Throughput Bioreactor System for the Pilot Bioproduction Facility at the Walter Reed Army Institute of Research in Silver Spring, Maryland. This procurement aims to enhance capabilities for monoclonal antibody production, allowing for simultaneous testing of multiple conditions to accelerate the manufacturing of vaccines and biologics for military-relevant infectious diseases. The system must meet specific Minimum Essential Characteristics, including the ability to process up to 12 cultures, automated controls for critical parameters, and compliance with FDA regulations, particularly 21 CFR Part 11 for data integrity. Interested vendors should note that the anticipated solicitation release is on April 10, 2025, with a contract performance period from June 1, 2025, to May 31, 2029. For further inquiries, contact Ms. Brenda Mena at brenda.i.mena.civ@health.mil or Ms. Sharew Hailu at sharew.hailu.civ@health.mil.

Point(s) of Contact
Brenda Mena
brenda.i.mena.civ@health.mil
Sharew Hailu
sharew.hailu.civ@health.mil
Files
Title
Posted
-MEC - Ambr 250 Bioreactor system.pdf
Mar 25, 2025, 4:06 PM UTC
The document outlines the Minimum Essential Characteristics (MEC) for a High Throughput Bioreactor required for government RFPs and grants. Key specifications include the capacity to process up to 12 simultaneous cultures of mammalian and microbial cells, utilizing single-use vessels, and featuring programmable PID control for pH and dissolved oxygen management. It emphasizes the integration of automated aseptic processes, full control of gas flow for headspace gassing, and the need for connections to analytical instruments for real-time data processing. The bioreactor must accommodate robotic liquid handling capabilities for sampling and liquid addition, along with features for scalable operation from a working volume of 100-250 mL to up to 30 L. Additional requirements include monitoring capabilities for pCO2, dissolved oxygen, and pH, as well as individual control for various parameters such as temperature, impeller speed, and gas flow. The system is expected to comply with 21 CFR Part 11 regulations, ensuring data integrity and security. Overall, the document serves as a comprehensive technical specification for procuring a bioreactor designed for sophisticated biological process management, underscoring the importance of automation, precision, and regulatory compliance in the context of government-funded research.
Draft- SOW - Ambr 250 Bioreactor system.pdf
Mar 25, 2025, 4:06 PM UTC
The Walter Reed Army Institute of Research (WRAIR) requests the procurement of a high-throughput bioreactor system to enhance its Pilot Bioproduction Facility (PBF) capabilities for monoclonal antibody production. This cutting-edge bioreactor will allow simultaneous testing of multiple conditions to accelerate the manufacturing of vaccines and biologics for military-relevant infectious diseases. The equipment will accommodate up to 12 parallel cultures and supports both mammalian and microbial cell cultures, with integrated controls for pH, dissolved oxygen, and automated processes. The contract specifies a base performance period spanning from June 2025 to May 2026, with options for annual extensions. Key deliverables include installation and operational qualification documentation, site acceptance testing, and ongoing maintenance. Compliance with FDA regulations, including 21 CFR Part 11, is essential for data integrity and security. The contractor must also provide training for personnel and ensure safety compliance per OSHA standards. This RFP reflects the government’s commitment to bolstering military health readiness through advanced biomanufacturing technologies, addressing both current and emerging infectious diseases that impact military personnel.
Lifecycle
Title
Type
Ambr 250 High Throughput Bioreactor System
Currently viewing
Presolicitation
Similar Opportunities
A Human Multi-Organ Tissue Equivalent Platform to Model High Consequence Threat Agents
Buyer not available
The Department of Defense, through the Army Medical Research Acquisition Activity, is seeking a contractor to develop a Human Multi-Organ Tissue Equivalent Platform aimed at modeling high consequence threat agents. This initiative focuses on creating a micro-engineered organ/tissue equivalent platform that will facilitate the modeling of pathogenic outcomes from emerging infectious diseases and the testing of medical countermeasures, particularly for respiratory viruses such as SARS-CoV-2, MERS, and pandemic H1N1 influenza. The project is critical for enhancing the military's capability to protect warfighters from both natural and manmade threats, ensuring rapid identification of effective medical responses. Interested contractors must submit their capabilities by 10:00 AM EST on April 14, 2025, and can direct inquiries to Kirstin L. Quinn at Kirstin.L.Quinn.civ@health.mil.
Notice of Intent to Sole Source_ CN Bio Innovations
Buyer not available
The Department of Defense, through the U.S. Army Medical Research Acquisition Activity (USAMRAA), intends to award a sole-source contract to CN Bio Innovations Limited for the procurement of a PhysioMimix Organ-on-a-Chip (OOC) Multi-Organ Standard System and a Full System. This specialized equipment is required to support the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) and must facilitate advanced organ modeling, including adjustable perfusion and fluidics, 3D organ model formation, and automation for long-term experiments. The systems will include necessary accessories and training for personnel, with a warranty period of two years post-delivery. Interested vendors may challenge this sole-source determination by submitting a capability statement by April 14, 2025, and inquiries should be directed to Matthew Gembe at matthew.w.gembe.civ@health.mil or by phone at 301-619-1350.
Microbial Identification System (MIS)
Buyer not available
The Department of Defense, through the United States Army Health Contracting Activity, is seeking information regarding a commercial solution for a Microbial Identification System (MIS) to enhance its MicroScan autoSCAN-4 System. The objective is to procure a system that meets the Critical Operational Device Specifications (CODS), which include operational characteristics, support for specific testing panels, and compatibility with a LabPro computer running Windows 11. This procurement is crucial for ensuring reliable laboratory systems in medical environments, particularly in austere settings. Interested vendors must submit their responses by 4:00 PM Central Time on April 3, 2025, to Linda McGhee at linda.a.mcghee.civ@health.mil, and are encouraged to provide detailed information about their capabilities and products as outlined in the RFI documents.
Water for Injection/Pure Steam Generation and Distribution Systems Maintenance
Buyer not available
The Department of Defense, through the Army Medical Research Acquisition Activity, is soliciting proposals from small businesses for the maintenance of Water for Injection (WFI) and Pure Steam Generation systems at the Walter Reed Army Institute of Research in Silver Spring, Maryland. The contract encompasses a range of maintenance services, including quarterly, semiannual, and annual tasks, as well as emergency response capabilities, all aimed at ensuring compliance with Current Good Manufacturing Practices (CGMP). This maintenance is critical for supporting the facility's mission of enhancing Soldier health through biological product research. Interested vendors must submit their proposals by April 15, 2025, and can direct inquiries to Ashley Atkins at ashley.n.atkins.civ@health.mil or by phone at 301-619-2297.
Workbench Software
Buyer not available
The Department of Defense, through the Defense Health Agency (DHA) and the Army Medical Research Acquisition Activity, is seeking information regarding the procurement of Workbench Software for the Walter Reed Army Institute of Research (WRAIR). This Request for Information (RFI) aims to identify a commercial bioinformatics software solution capable of supporting DNA and RNA analysis, specifically for next-generation sequencing (NGS) workflows, interpretations, and visualizations. The software will play a crucial role in enhancing military health performance and readiness by providing advanced analytical capabilities for genomic data. Interested parties are encouraged to submit their capabilities statements electronically by April 14, 2025, to Mr. Keith C. Crum at keith.c.crum.civ@health.mil, with the contract's base period commencing on May 30, 2025, and extending through multiple option periods until May 29, 2030.
Microbial Testing Supplies - Bridge Contract
Buyer not available
The Department of Defense, specifically the Department of the Army, is seeking to award a sole-source bridge contract for microbial testing supplies to Biomerieux Inc., covering the period from October 1, 2024, to September 30, 2025. This procurement is essential for the William Beaumont Army Medical Center Laboratory, as it involves leasing a microbial identification analyzer and a mass spectrometer, along with necessary reagents and middleware/server interface provision. The unique requirements for ATO authorization on DHA networks necessitate this sole-source approach, as Biomerieux is the only contractor capable of meeting these needs without service disruption. Interested parties can contact Troy Loge at troy.a.loge.civ@health.mil or Robyn Villafranco at Robyn.A.Villafranco.civ@health.mil for further details, with the total contract value estimated at $213,334.67.
Biostatistical Software
Buyer not available
The Department of Defense, through the Defense Health Agency (DHA), is conducting market research for biostatistical software solutions, specifically targeting Cytel’s East Horizon software and its associated modules. The objective is to identify commercial items that can fulfill specific biostatistical requirements essential for meeting FDA regulatory standards in medical research. This RFI is crucial for gathering insights into available software that supports various clinical trial designs and statistical analyses across the ORA portfolios. Interested vendors are encouraged to submit white papers by April 23, 2025, to Matthew Gembe at matthew.w.gembe.civ@health.mil, with all submissions treated as proprietary and not returned.
Sources Sought Notice- Reagents for Chemisty Immunoassays Test
Buyer not available
The Department of Defense, through the Medical Readiness Contracting Office - West (MRCO-W), is seeking sources for a contract involving the supply of reagents for chemistry and immunoassay testing, along with the lease of two chemistry analyzers and two immunoassay analyzers. The procurement aims to enhance diagnostic capabilities at the William Beaumont Army Medical Center (WBAMC) by providing a customizable laboratory track line, which includes essential modules such as centrifuges, cappers, and a deionized water unit, ensuring reliable and efficient patient care. Interested vendors must submit tailored capability statements and relevant documentation by April 17, 2025, at 10 AM (MST) to the designated contacts, Fabiola Palma-Trujillo and Robyn Villafranco, via email. This opportunity is part of the government's market research and does not constitute a commitment to contract.
TEMPERATURE AND OTHER ENVIRONMENTAL CONTROL MONITORING SERVICES
Buyer not available
The Defense Health Agency (DHA) is soliciting proposals for Temperature and Other Environmental Control Monitoring Services at the Walter Reed National Military Medical Center (WRNMMC) in Bethesda, Maryland. The contract requires the contractor to provide maintenance, technical support, and monitoring services for an existing environmental monitoring system, which includes a total of 1,200 inputs across seven management nodes, ensuring compliance with regulatory standards and operational reliability. This procurement is critical for maintaining the health and safety standards within military medical facilities, emphasizing the need for modernized systems and stringent data security measures. Interested vendors must submit their proposals by April 15, 2025, and can direct inquiries to Judith S. Meynard at Judith.S.Meynard.ctr@health.mil or Erica S. Oh at erica.s.oh.civ@health.mil.
Skalar Equipment Maintenance
Buyer not available
The Department of Defense, through the U.S. Army Medical Research Acquisition Activity (USAMRAA), intends to procure maintenance services for Skalar Robotic Analyzer SP2000 equipment on a sole source basis from Skalar, Inc. The procurement includes annual preventive maintenance, repair services, parts replacement, and one emergency visit per year, with a contract period anticipated to consist of one base year and four option years. This maintenance is crucial for ensuring the operational efficiency of laboratory equipment used in public health initiatives. Interested parties must submit a capabilities statement by April 21, 2025, at 12:00 PM EST, to the primary contact, Monica Perez, at monica.c.perez3.civ@health.mil.