Ambr 250 High Throughput Bioreactor System
ID: PANDHA25P0000-007301Type: Sources Sought
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/24683d3341424317ae64902a5cb93c17/view
Timeline
    Description

    The Department of Defense, through the Defense Health Agency (DHA) and the Army Medical Research Acquisition Activity, is seeking sources for the procurement of an Ambr 250 High Throughput Bioreactor System. This bioreactor is required to support up to 12 simultaneous cultures for both mammalian and microbial cells, with features such as automated aseptic processing, programmable control loops for pH and dissolved oxygen, and compliance with current Good Manufacturing Practices (cGMP) and 21 CFR Part 11 regulations. The system will enhance the capabilities of the Walter Reed Army Institute of Research's Pilot Bioproduction Facility for the production of monoclonal antibodies, aligning with the government's focus on advancing health technologies for military medical readiness. Interested parties should contact Brenda Mena at brenda.i.mena.civ@health.mil or Sharew Hailu at sharew.hailu.civ@health.mil for further details, with the performance period for the contract expected to run from June 2025 to May 2026.

    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) required for a High Throughput Bioreactor, intended for federal RFPs and grants. The bioreactor must support up to 12 simultaneous cultures for both mammalian and microbial cells, utilizing single-use vessels and providing extensive control features, including programmable PID control loops for pH and dissolved oxygen. Key specifications include automated aseptic processing, integration with analytical instruments, and self-contained cooling systems. The design emphasizes a scalable vessel format, allowing for small volume high throughput from 100 to 250 mL, with the capability to scale up to 30 L. Each bioreactor requires individual controls for temperature, agitation, gas flow, and sampling, along with the ability to monitor and manage various gases and pH levels. Additionally, it must feature integrated clean-in-place systems and comply with 21 CFR Part 11 requirements for data integrity. This document is essential for guiding manufacturers and service providers in developing bioreactor systems that meet specific scientific and regulatory standards, emphasizing automation, precision, and scalability in bioprocessing applications.
    SOW - Ambr 250 Bioreactor system.pdf
    The Statement of Work (SOW) outlines a requirement by the Walter Reed Army Institute of Research (WRAIR) for a high throughput bioreactor to enhance its Pilot Bioproduction Facility's capacity to produce monoclonal antibodies. This bioreactor needs to accommodate up to 12 simultaneous cultures, facilitating rapid and scalable fermentation processes for the development of biologics and therapeutics. The SOW details the objectives, including the procurement of an integrated bioreactor system compliant with current Good Manufacturing Practices (cGMP) and 21 CFR Part 11 regulations, with essential features such as automated liquid handling, software for predictive scale conversion, and a one-year service and maintenance package. The performance period specified includes a base contract from June 2025 to May 2026 and outlines optional maintenance periods. The contractor is responsible for installation, site acceptance testing, and extensive operator training. Compliance with federal laws, especially related to health and safety, and data privacy, is emphasized throughout. The document reflects the federal government's emphasis on acquiring advanced technology to address health threats effectively and enhance military medical readiness, aligning with broader government RFP objectives for public health and safety innovation.
    Lifecycle
    Title
    Type
    Ambr 250 High Throughput Bioreactor System
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