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
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    No associated files provided.
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    Title
    Type
    Manufacturing: Monoclonal Antibody Reference Material
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