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
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