Notice of Intent: Gemini Bio-GemCell TM Plus Xeno free Reagents
ID: 24-013197Type: Presolicitation
Overview

Buyer

HEALTH AND HUMAN SERVICES, DEPARTMENT OFNATIONAL INSTITUTES OF HEALTHNATIONAL INSTITUTES OF HEALTH - CCBETHESDA, MD, 20892, USA

NAICS

Biological Product (except Diagnostic) Manufacturing (325414)

PSC

IN VITRO DIAGNOSTIC SUBSTANCES, REAGENTS, TEST KITS AND SETS (6550)
Timeline
    Description

    The National Institutes of Health (NIH) intends to award a sole-source contract to Gemini Bio for the supply of GemCell™ Plus Xeno-Free reagents, essential for the Center for Cellular Engineering's operations in Bethesda, Maryland. This procurement is critical as the Center relies on these specific reagents for manufacturing human cell and tissue-based products used in clinical trials, which are vital for patient care and treatment protocols. The unique compatibility of Gemini Bio's products with existing manufacturing processes makes them the only viable source, as switching vendors would incur significant costs and delays, potentially impacting patient outcomes. Interested parties may submit capability statements to Sheri Eiri at sheri.eiri@nih.gov by September 8, 2024, at 12:00 PM EST for consideration.

    Point(s) of Contact
    Files
    No associated files provided.
    Lifecycle
    Title
    Type
    Similar Opportunities
    NIEHS - Exodus H-600
    Active
    Health And Human Services, Department Of
    The National Institute of Environmental Health Sciences (NIEHS) intends to negotiate a sole-source contract with Exodus Bio, Inc. for the acquisition of an Exodus H-600 automatic exosome isolation system. This procurement aims to enhance the NIEHS's capabilities in biological product manufacturing, specifically focusing on the isolation of exosomes, which are critical for various research applications in environmental health. The contract, associated with NAICS Code 325414, is expected to include one unit of the specified equipment, with a delivery timeframe of 60 days post-award. Interested parties capable of fulfilling this requirement are encouraged to submit a capability statement via email by September 18, 2024, and inquiries can be directed to Tanya Redfearn at shields3@niehs.nih.gov or by phone at 984-287-3052.
    Notice of Intent BD Rhapsody Single-Cell Analysis Reagent Kits
    Active
    Health And Human Services, Department Of
    Notice of Intent BD Rhapsody Single-Cell Analysis Reagent Kits The Department of Health and Human Services, Department of, National Institutes of Health, is planning to procure BD Rhapsody Single-Cell Analysis Reagent Kits. These kits are used for the manufacture of human cells and tissue-based products utilized in phase I/II clinical protocols for transplantation, adoptive immunotherapy, and gene therapy conducted in the Clinical Center at the NIH. The procurement includes a standing order for multi-type sequencing kits and reagents with a short shelf life. The contractor will be responsible for shipping the sufficient reagents and kits following the scheduled delivery dates. The shelf life of the sequencing reagents should be at least 3 months, and the shelf life of library generation kits should be at least 6 months. The contractor is also required to provide technical support for all kits and reagents at no additional cost. The period of performance for this procurement is from 5/1/2024 to 8/30/2024. The delivery schedule is overnight delivery Monday through Thursday to the Center for Cellular Engineering (CCE) at NIH/CC in Bethesda, MD. The vendor will be responsible for ensuring the safe transport of cryopreserved patient cells and maintaining the temperature and other parameters during the shipment of reagents and kits. The contractor will be paid per product delivered and is required to provide hard copies of proofs of each product delivered. Interested parties can submit their capabilities to the Office of Purchasing and Contracts by May 1st, 9:00 AM EST. Please note that this is not a request for proposal.
    Good Manufacturing Practice (GMP)-manufactured Monoclonal Antibody
    Active
    Health And Human Services, Department Of
    The National Institutes of Health (NIH), specifically the National Institute of Allergy and Infectious Diseases (NIAID), intends to award a sole source contract for the procurement of Good Manufacturing Practice (GMP)-manufactured Monoclonal Antibody UB-421, with a requirement of 100 liters. This procurement is critical for an ongoing clinical trial aimed at treating patients with multidrug-resistant HIV-1 infection, utilizing UB-421, which is exclusively manufactured by United BioPharma, Inc., the sole patent holder and provider of the necessary cell line for production. Interested parties who believe they can meet the specifications must submit a capability statement to the primary contact, Hershea Vance, by 3:00 PM EST on September 20, 2024, as the contract is expected to be awarded within 19 days of this notice, with a performance period from September 23, 2024, to September 24, 2025.
    BD FACS Symphony S6 Cell Sorter (Brand Name or Equal)
    Active
    Health And Human Services, Department Of
    The National Institutes of Health (NIH), specifically the National Institute of Allergy and Infectious Diseases (NIAID), is seeking to procure one (1) BD FACSymphony S6 SE Cell Sorter System (or equal) along with a twelve-month maintenance agreement for parts and labor. This procurement is critical as the existing cell sorter is nearing the end of its life cycle, and the new system must meet specific requirements, including compatibility with FlowJo software and advanced operational safety features, to support high-containment research involving infectious samples. Interested vendors are required to submit comprehensive quotes by September 19, 2024, with evaluations focusing on technical acceptability, past performance, and price to ensure the best value for the government. For further inquiries, vendors can contact Linda Smith at linda.smith2@nih.gov or Christian Brown at christian.brown@nih.gov.
    Using humanized mouse models of NNMT and SULT1A1 for follow-up efficacy studies
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, through the National Institutes of Health (NIH) and its National Center for Advancing Translational Sciences (NCATS), intends to award a sole-source contract to GemPharmatech, LLC for follow-up efficacy studies utilizing humanized mouse models of NNMT and SULT1A1. The primary objective of this procurement is to conduct a series of studies, including a Maximum Tolerated Dose (MTD) study, a pharmacokinetic (PK) study, and an efficacy study, to evaluate small molecule inhibitors developed by NCATS, necessitating the creation of mouse models that express human versions of the enzymes involved. This research is critical for advancing the development of therapeutics targeting various human diseases, and the project is expected to span 12 months. Interested parties may submit their capabilities by September 17, 2024, to Michelle Cecilia at michelle.cecilia@nih.gov, with the contract value and specific funding details not disclosed in the announcement.
    Notice of Intent to Sole Source – Medtronic
    Active
    Health And Human Services, Department Of
    The National Institutes of Health (NIH) intends to award a sole source contract to Medtronic USA, Inc. for the procurement of Concerto Coils and Vascular Plug Systems essential for patient care at the NIH Clinical Center in Bethesda, Maryland. The acquisition includes specific product numbers and quantities, highlighting the unique features of these medical devices that are critical for the clinical needs of the facility. This procurement is being conducted under the Federal Acquisition Regulation (FAR) Part 13, allowing for a sole source award due to the specialized nature of the products. Interested parties may express their interest and capabilities to Kristin Nagashima at kristin.nagashima@nih.gov by September 17, 2024, at 8 AM EST.
    Next-Generation Sequencing (NGS) Liquid Handling Systems – Brand Name or Equal
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the National Institutes of Health (NIH), is seeking quotes for two Next-Generation Sequencing (NGS) Liquid Handling Systems to enhance research capabilities at its Bethesda, Maryland campus. These systems are essential for high-throughput processing in infectious disease research, particularly for single cell-based antibody discovery and RNA/DNA processing, which are critical for pandemic preparedness. Interested vendors must submit their quotes by 12:00 pm EST on September 26, 2024, including detailed specifications and compliance with federal regulations, to Daveta H. Brown at daveta.brown@nih.gov.
    Brand-Name or Equal Axion Biosystems 48-well microelectrode array plates for the National Center for Advancing Translational Sciences
    Active
    Health And Human Services, Department Of
    The National Institutes of Health (NIH) is seeking proposals for the procurement of Axion Biosystems 48-well microelectrode array plates, specifically the CytoView MEA 48 model, as part of a project aimed at evaluating the safety of antisense oligonucleotides in neurological treatments. The acquisition includes 10 boxes of these plates, which are crucial for conducting neurotoxicity screening assays by recording neuronal electrical signals, thereby facilitating both acute and chronic toxicity assessments. Interested vendors must submit their quotations by 4:00 PM EDT on September 9, 2024, to the Contracting Officer, Mark McNally, at mark.mcnally@nih.gov, with the anticipated award date set for September 12, 2024. The procurement is expected to follow simplified acquisition procedures, with no set-aside restrictions, and the total price must encompass all shipping and handling costs.
    Piflufolastat F-18 injection drugs (Pylarify) from Sofie Co. (Notice of Intent to sole source)
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the National Institutes of Health (NIH), intends to negotiate a sole-source contract with Sofie Co. for the procurement of Piflufolastat F-18 injection drugs (Pylarify) essential for clinical nuclear medicine procedures at the NIH Clinical Center. This acquisition aims to secure compounded, patient-ready doses of the radiopharmaceutical, which is critical for diagnosing and treating diseases in accordance with patient care protocols. The drugs are FDA-approved and must be compounded and delivered on a time-sensitive basis due to their rapid radiation decay, making Sofie Co. the only authorized provider capable of meeting these specialized requirements. Interested parties may submit capability statements by September 18, 2024, to Lu Chang at lu-chang.lu@nih.gov, as this is not a request for proposals.
    Ambr 250 or Equal High Throughput Bioreactor System for NIAID VPP
    Active
    Health And Human Services, Department Of
    The National Institutes of Health (NIH), specifically the National Institute of Allergy and Infectious Diseases (NIAID), is seeking quotes for the procurement of two Ambr 250 or equivalent high-throughput bioreactor systems for its Vaccine Production Program (VPP). The primary objective is to replace aging equipment that has caused operational delays, thereby enhancing the efficiency of the Cell Culture Development team in their mission to develop vaccines for critical pathogens such as HIV and Ebola. This acquisition is vital for maintaining uninterrupted research operations and ensuring timely project milestones. Interested vendors must submit their quotes by 3:00 PM EST on September 17, 2024, to Kathy Song at kathy.song@nih.gov, and must comply with all specified technical requirements and federal contracting regulations.