Manufacturing: Monoclonal Antibody Reference Material
ID: NIST-MML-24-SS05Type: Sources Sought
Overview

Buyer

COMMERCE, DEPARTMENT OFNATIONAL INSTITUTE OF STANDARDS AND TECHNOLOGYDEPT OF COMMERCE NISTGAITHERSBURG, MD, 20899, USA

Original Source

https://sam.gov/opp/d2758a1f8c574d01b77b966fcb89c4bd/view
Timeline
    Description

    Sources Sought COMMERCE, DEPARTMENT OF NATIONAL INSTITUTE OF STANDARDS AND TECHNOLOGY is seeking vendors who can potentially perform additional upstream/downstream process development and scale-up to produce 1-5 kg of cNISTmAb from a single bioreactor run. The material is intended for research use and is not intended for animal or human consumption, clinical testing, or therapeutic use. The intent is to produce research-grade material in an environment representative of all salient features of biopharmaceutical biomanufacturing. Vendors should indicate their capabilities regarding "GMP-like" manufacturing, delivery of mAb at 100 mg/mL in L-Histidine, documentation/description of capabilities of biomanufacturing workflow, container closure for a 100 mg/mL mAb substance, assurance of homogeneity across individual mAb substance containers, batch records and/or process data, relevant experience handling CHOZN cell lines and manufacturing of biopharmaceutical products, and the ability to deliver a portion of the mAb as finished Reference Material. Interested parties should email a written response to donald.graham@nist.gov. NIST anticipates issuing a Request for Quotation in the second quarter and awarding a contract no later than the fourth quarter of fiscal year 2024.

    Point(s) of Contact
    Don Graham
    (301) 975-8567
    deg@NIST.GOV
    Files
    No associated files provided.
    Lifecycle
    Title
    Type
    Manufacturing: Monoclonal Antibody Reference Material
    Currently viewing
    Sources Sought
    Similar Opportunities
    Nanoparticle Nebulizers
    Active
    Commerce, Department Of
    The Department of Commerce, specifically the National Institute of Standards and Technology (NIST), is seeking sources for the procurement of two nanoparticle nebulizers designed to enhance semiconductor manufacturing yield through improved metrology for cleaning chemical purity. These nebulizers must generate ultrafine native particles smaller than 10 nm from ultra-pure water while minimizing interference from non-volatile particle precursors, and will be utilized in a controlled laboratory environment. This initiative is critical for advancing particle metrology in semiconductor cleaning processes, aligning with the industry's need for higher purity materials. Interested vendors should submit their responses, including technical specifications and company information, to the primary contact, Jenna Bortner, at jenna.bortner@nist.gov, by the specified deadline, ensuring they are registered and active in SAM.gov.
    Reagent Generation for Bioanalytical Method Development on Biologics
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the National Institutes of Health (NIH), is seeking qualified sources for a potential contract focused on reagent generation for bioanalytical method development related to biologics. The primary objective is to obtain information on the availability and capability of companies to generate and deliver reagents, including anti-drug antibodies, that support the quantification of novel biologic drugs in various biological matrices. This initiative is crucial for advancing drug development processes and improving success rates in preclinical stages, with the Therapeutic Development Branch (TDB) at NIH playing a pivotal role in moving therapeutic candidates through the drug development pipeline. Interested parties must submit their capability statements by November 8, 2024, to Nick Niefeld at nick.niefeld@nih.gov, referencing sources sought notice number 75N95025R00007.
    Reagent Dispenser
    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 information on domestically manufactured reagent dispensers through a Sources Sought notice. The procurement aims to identify U.S.-made products that meet stringent specifications, including features such as custom plate addition, high precision peristaltic pumping, and a dispensing volume capacity ranging from 0.5 to 2500μl, among others. This initiative underscores the importance of domestic manufacturing in scientific and medical instrumentation, aligning with the Buy American Act and Executive Order 14005. Interested vendors must submit their capability statements by October 25, 2024, to Kelly Lowe at kelly.lowe@nih.gov, ensuring compliance with the outlined requirements and confidentiality stipulations.
    Hardware and Software upgrade for IMS 1280
    Active
    Commerce, Department Of
    The National Institute of Standards and Technology (NIST) is seeking information from potential vendors for a hardware and software upgrade for the IMS 1280 mass spectrometer. The procurement aims to enhance the instrument control software and computer systems, including necessary cables and OEM software, along with a software manual. This upgrade is crucial for maintaining the operational efficiency of the analytical laboratory instrument, which plays a significant role in various scientific applications. Interested parties are encouraged to submit their capabilities and relevant information to Don Graham at deg@nist.gov by the specified response date, as NIST anticipates issuing a Request for Quotation in early FY2025, with contract awards expected by the third quarter of FY2025.
    Nano-differential mobility analyzer and water-based condensation particle counter upgrades
    Active
    Commerce, Department Of
    The Department of Commerce, specifically the National Institute of Standards and Technology (NIST), is seeking sources for upgrades to a nano-differential mobility analyzer (nano-DMA) and a water-based condensation particle counter (w-CPC) to enhance semiconductor manufacturing capabilities. The objective is to develop a system that can accurately measure the size distribution and number density of sub-50 nm particles, which is critical for ensuring the purity of cleaning chemicals used in semiconductor manufacturing processes. This procurement is vital for advancing metrological capabilities in particle detection, which is essential for the production of next-generation semiconductor materials. Interested vendors should respond to the notice by contacting Jenna Bortner or Forest Crumpler via email, providing detailed information about their capabilities and products, with responses encouraged before the specified deadline.
    Nano-Spotlight
    Active
    Commerce, Department Of
    The Department of Commerce, specifically the National Institute of Standards and Technology (NIST), is seeking information from potential sources capable of providing a Nano-Spotlight system for aerosol-based testing in semiconductor manufacturing. This system is essential for generating and collecting aerosolized particles from ultrapure water, which will be used for offline analysis to enhance semiconductor manufacturing yield by ensuring the purity of cleaning chemicals. The procurement aims to address critical challenges in particle metrology and is part of a broader initiative to support next-generation chip production. Interested vendors should submit their responses, including technical specifications and company information, to the primary contact, Jenna Bortner, at jenna.bortner@nist.gov, by the specified deadline. This notice serves as a market research tool and does not guarantee a contract award.
    Office of Advanced Manufacturing (OAM) being a Foundational Sponsor for the 2024 Manufacturing Momentum Summit - Combined Sources Sought/Notice of Intent to Sole Source
    Active
    Commerce, Department Of
    The Department of Commerce, specifically the National Institute of Standards and Technology (NIST), is seeking sources capable of providing foundational sponsorship for the 2024 Manufacturing Momentum Summit. The requirements for this sponsorship include registrations for various NIST teams, speaker opportunities, display space for Manufacturing USA Institutes, and recognition in event communications. This sponsorship is crucial for promoting advanced manufacturing initiatives and fostering collaboration among industry stakeholders. Interested parties should respond to Robert Singman at robert.singman@nist.gov by October 15, 2024, with their capabilities and any questions regarding the opportunity.
    Nano-scanning mobility particle sizer (nano-SMPS)
    Active
    Commerce, Department Of
    The Department of Commerce, specifically the National Institute of Standards and Technology (NIST), is seeking information from potential sources capable of providing a nano-scanning mobility particle sizer (nano-SMPS) system. This system is essential for enhancing semiconductor manufacturing yield by enabling the detection, identification, and quantification of sub-50 nm particles in cleaning chemicals, which is critical for the production of next-generation chips. The nano-SMPS will be utilized in a controlled laboratory environment to assess the efficiency of ultrafiltration systems and will require specific components such as an electrostatic classifier, charge neutralizer, differential mobility analyzer, and condensation particle counter. Interested parties should respond to the notice by contacting Jenna Bortner or Forest Crumpler via email, ensuring their submissions are complete and adhere to the outlined requirements, as this notice is for market research purposes and does not constitute a commitment to award a contract.
    Chemistry, Manufacturing and Controls and Related Services for Development of Drug Products
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the National Institutes of Health (NIH) through the National Center for Advancing Translational Sciences (NCATS), is seeking qualified small businesses to provide Chemistry, Manufacturing, and Controls (CMC) and related services for the development of drug products. The objective of this procurement is to support the Therapeutic Development Branch in ensuring the delivery of drug products of sufficient quality and quantity for preclinical, IND-enabling, and clinical studies, which are critical for advancing therapeutic candidates through the drug development pipeline. This opportunity is part of a Small Business Sources Sought notice, aimed at gathering information on the capabilities of small businesses to fulfill these requirements, with a focus on compliance with applicable regulations and the potential for a multiple-award Indefinite Delivery/Indefinite Quantity (IDIQ) contract. Interested vendors must submit their capability statements by 10:00 AM Eastern Time on July 21, 2024, to Michelle Cecilia at michelle.cecilia@nih.gov.
    Assay Kits for Lumipulse instrument
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the National Institutes of Health (NIH), is seeking information from qualified sources regarding the availability of assay kits for the Lumipulse G1200 instrument, which is essential for conducting assays related to Alzheimer's disease biomarkers. The procurement aims to acquire state-of-the-art assay kits for quantifying serum/plasma levels of abeta42, abeta40, and pTau 217, which will be utilized in ongoing research involving stored specimens from the Baltimore Longitudinal Study of Aging (BLSA). Interested vendors are encouraged to submit capability statements detailing their ability to meet the project requirements, including manufacturing details and company qualifications, by October 28, 2024, at 5 PM Eastern Time, to Iris Merscher at iris.merscher@nih.gov. This notice serves as a Sources Sought announcement and does not constitute a solicitation for proposals or quotes.