The National Institute of Standards and
Technology (NIST) is seeking vendors for the contract vialing of monoclonal antibody reference material. The period of performance is 18 months from the award of the contract. The work will be completed at the contractor's facility, and the homogenized bulk monoclonal antibody deliverable units will be transferred to the NIST Office of Reference Materials storage facility. The contractor must attend a kickoff meeting within 14 days of contract award, and participate in status meetings on a minimum monthly basis. The contractor must provide a final report with a detailed explanation of the steps involved in material preparation, including transportation, estimated time of each step, temperature, methodology and instrumentation used for dilution, fill, freeze, and storage, methodology and instrumentation used for analytical testing, and product specifications. The contractor must also provide progress reports every two weeks. The contractor must deliver 30,000 labeled vials of 10 mg/ml nistmab rm **** monoclonal antibody separated into 3 lots of 10,000 vials each, 10,000 labeled vials of 10 mg/ml nistmab ps **** monoclonal antibody in one lot of 10,000 vials, and 30,000 labeled vials of 10 mg/ml cnistmab rm **** monoclonal antibody separated into 3 lots of 10,000 vials each. The material must remain frozen at -80C. The protein concentration should be 0. 5 mg/ml of the 10 mg/ml target concentration as demonstrated by UV-Vis absorption. The purity of the monomeric molecule shall be 95% and demonstrated through high-performance size exclusion chromatography. The contractor must arrange for appropriate transportation and/or shipping of the labeled monoclonal antibody containers, which maintains the units under appropriate dry ice storage conditions (-80C), to the NIST Office of Reference Materials (ORM) or other NIST provided location. The contractor will maintain responsibility for the quality of the monoclonal antibody units until they are officially received by NIST ORM. The contractor shall deliver, as an electronic PDF document, a compiled report of analysis of the monoclonal antibody containers. NIST will review the report within 15 working days. NIST reserves the right to address scientific or quality questions to appropriate contractor representatives, and to pause the review period while awaiting contractor response. The government retains a government use license to all inventions arising from this work. Contractor employees must comply with NIST identification and access requirements and wear a visible identification badge. Media inquiries must be relayed to the NIST director. The source sought is not a request for quotation. It is a market research tool to determine potential and eligible business firms that can provide the product described. Responses should include the country where the product is manufactured, spec data sheets, examples of products, typical lead time, and any other relevant information. The capability statement must be received by the contracting officer, Angela Hitt, via email no later than the date and time posted in the notice.