Manufacturing: Monoclonal Antibody Reference Material
ID: 1333ND24QNB640640Type: Combined Synopsis/Solicitation
Overview

Buyer

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

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714)

PSC

CHEMICALS (6810)

Original Source

https://sam.gov/opp/4db1faa2337d4283b3bb8541b0c28ac8/view
Timeline
    Description

    The Department of Commerce, through the National Institute of Standards and Technology (NIST), is seeking quotations for the manufacturing of a monoclonal antibody reference material derived from the NISTCHO cell line. The objective is to develop a monoclonal antibody that adheres to Good Manufacturing Practices (GMP) standards, which will serve as a reference material for the biopharmaceutical industry, ensuring high quality and consistency in bioprocesses. This procurement is critical for advancing biopharmaceutical development and will involve a firm-fixed-price purchase order for approximately 1 kilogram of purified monoclonal antibody, with quotations due by 12:00 PM EST on September 13, 2024. Interested contractors must contact Sadaf Afkhami at Sadaf.Afkhami@nist.gov or Donald Graham at Donald.Graham@nist.gov for further details.

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    Attachment 1- Statement of Requirement.pdf
    The document outlines a Request for Proposal (RFP) from the National Institute of Standards and Technology (NIST) for the manufacturing of a monoclonal antibody reference material derived from the NISTCHO cell line. The project focuses on developing a monoclonal antibody that adheres to Good Manufacturing Practices (GMP) standards, intended for use in biopharmaceuticals. Key contractor qualifications include experience with large-scale biopharmaceutical production and a facility that reflects biopharmaceutical manufacturing processes. The document details a three-step manufacturing process, beginning with a pilot run, followed by scale-up production, and ending with the homogenization of produced batches. Each step outlines specific deliverables, including product testing, documentation, and compliance evaluations, emphasizing the importance of maintaining product quality. The contract's duration is 18 months, with stipulations regarding the delivery of samples, reports, and compliance with NIST specifications. Emphasis is placed on the need for secure transportation and handling of materials to maintain integrity throughout the process. The government retains usage rights to inventions arising from this work, ensuring its investment in this significant biopharmaceutical development initiative is protected.
    Attachment 2- Provisions and Clauses.pdf
    The document outlines federal acquisition regulations and solicitation provisions applicable to an unspecified procurement. It emphasizes the incorporation of solicitation provisions by reference, maintaining their full text availability upon request. Key provisions include requirements relating to the System for Award Management, representations and certifications regarding telecommunications equipment, public disclosures of greenhouse gas emissions, and trade agreements compliance. Additionally, it stipulates prohibitions on contracting with entities involved with certain telecommunications services or those with delinquent tax liabilities. The document details the obligations of offerors, such as conducting reasonable inquiries to ascertain compliance with telecommunications equipment regulations and presenting disclosures for various representations. Procedures for submitting electronic invoices to the National Institute of Standards and Technology (NIST) and handling agency protests are also discussed. The provisions highlight accountability, compliance with federal laws, and adherence to affirmative action procedures. This RFP document serves as a comprehensive guide to ensure compliance with federal standards and regulations in procurement processes.
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    Manufacturing: Monoclonal Antibody Reference Material
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    Combined Synopsis/Solicitation
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