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
    Description

    The Department of Defense, through the Army Medical Research Acquisition Activity, is soliciting proposals for the procurement of a Brand Name Ambr 250 High Throughput Bioreactor system to enhance monoclonal antibody production capabilities at the Walter Reed Army Institute of Research (WRAIR). The bioreactor must support up to twelve simultaneous cultures, be compatible with both mammalian and microbial cell cultures, and include features such as programmable control loops, automated processes, and real-time data display. This procurement is critical for advancing biotechnological research and vaccine development within a cGMP-compliant facility, with proposals due by July 15, 2025. Interested small businesses should direct inquiries to Brenda Mena or Sharew Hailu via email, and are encouraged to review all attached documents for detailed specifications and requirements.

    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
    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.
    Attachment 1 - SOW - Ambr 250 Bioreactor system rev.pdf
    The Statement of Work (SOW) outlines the requirement for a high throughput bioreactor to enhance the production capabilities for monoclonal antibodies at the Walter Reed Army Institute of Research's Pilot Bioproduction Facility (PBF). This cGMP-compliant facility develops vaccines for military-relevant infectious diseases, producing 500 to 2,000 doses per batch. The new bioreactor system should allow rapid and scalable fermentation processes through parallel operation of multiple bioreactors, significantly improving the efficiency of vaccine and drug development. Key deliverables include installation, site acceptance testing, operational qualifications, and comprehensive training for staff, with an overall contract period extending from August 2025 to August 2029. The contractor must meet various performance and compliance requirements, including technology aligned with safety regulations and capabilities for automated sample processing. The bioreactor must also ensure certain Minimum Essential Characteristics (MECs), such as real-time data display and programmability, to facilitate effective research development. This procurement reflects the U.S. Department of Defense's commitment to advancing medical capabilities for service members, addressing infectious disease challenges through innovative technologies.
    Attachment 2 - MEC - Ambr 250 Bioreactor system.pdf
    The document outlines the Minimum Essential Characteristics (MEC) for a High Throughput Bioreactor required for federal and state RFPs. The bioreactor must support up to twelve simultaneous cultures for Design of Experiments (DOE) and be compatible with mammalian and microbial cell cultures using single-use vessels. Key features include programmable PID control loops for pH and dissolved oxygen management, an integrated sterile operating environment for automated processes, and capabilities for analytical instrument integration. The bioreactor should allow robotic liquid handling, involve real-time data display and predictive scaling capabilities, and accommodate small volumes (100-250 mL) up to scalability of 30 L. Individual controls for temperature, impeller speed, gas flow, and sampling must be provided. Additional specifications encompass a clean in place (CIP)/sterilize in place (SIP) system for pumps and liquid lines. The MECs are designed to ensure the bioreactor can be effectively utilized in laboratory research settings and meet rigorous federal compliance standards, specifically concerning 21 CFR Part 11 requirements. The intention behind documenting these specifications reflects a commitment to advancing biotechnological research capabilities while emphasizing automation, efficiency, and regulatory adherence.
    Attachment 3 - JA Modified for FAR Part 13.501 Ambr 250 Bioreactor System_Redacted.pdf
    Draft- SOW - Ambr 250 Bioreactor system.pdf
    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.
    HT942525Q0036.pdf
    The document outlines a federal government solicitation (HT942525Q0036) for the procurement of an Amber 250 High Throughput Bioreactor system, including installation, calibration, maintenance services, and associated shipping. Proposals are due by July 15, 2025, requiring interested parties to submit technical, past performance, and price proposals in three distinct volumes. The evaluation criteria emphasize a Lowest Price Technically Acceptable process, expecting an acceptable technical rating to qualify for contract consideration. Key deliverables include adherence to regulatory guidelines, such as 21 CFR Part 11 assessments, on-site repairs within 48 hours, and documentation for site acceptance testing. The contractor must also be an authorized reseller of the bioreactor. The solicitation further details submission requirements, including necessary representations and certifications, and underscores the significance of compliance with FAR clauses. Overall, this solicitation exemplifies the federal acquisition process, focusing on transparency, competition, and performance standards within government contracting.
    Lifecycle
    Title
    Type
    Ambr 250 High Throughput Bioreactor
    Combined Synopsis/Solicitation
    BRAND NAME Ambr 250 High Throughput bioreactor for WRAIR
    Solicitation
    Ambr 250 High Throughput Bioreactor System
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