Ambr 250 High Throughput Bioreactor System
ID: PANDHA25P0000-007301Type: Special Notice
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/a1463e2582c14cd68886c1cbbc930534/view
Timeline
    Description

    The Department of Defense, through the Army Medical Research Acquisition Activity, intends to award a sole source contract for the Ambr 250 High Throughput Bioreactor System to Sartorius Stedim North America, Inc. This procurement aims to enhance the Pilot Bioproduction Facility at the Walter Reed Army Institute of Research by developing a monoclonal antibody production capability, which is critical for producing biologics and therapeutics to address military-relevant infectious disease threats. The bioreactor system must support up to 12 simultaneous cultures, comply with current Good Manufacturing Practices (cGMP), and include features such as automated liquid handling and extensive control capabilities. Interested parties may submit their capability information by 2:00 p.m. EST on March 27, 2025, to Ms. Brenda Mena at brenda.i.mena.civ@health.mil, as this notice is not a request for competitive quotations.

    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.
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    Ambr 250 High Throughput Bioreactor System
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