2 Questions and Answers .xlsx

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Vialing of Monoclonal Antibody
Solicitation number
NB645030-25-01699
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This document is a Questions and Answers (Q&A) spreadsheet for a Request for Quotation (RFQ) issued by the National Institute of Standards and Technology (NIST) for Monoclonal Antibody Reference Material Vialing. The Q&A addresses five key technical questions, including specific requirements for vial systems, labeling, dispense volume, purity testing methods, and past performance documentation. Critical details include a mandatory requirement to use Thermo Matrix vial and rack systems, a dispense volume of +/- 25 ul, high-performance size exclusion chromatography for purity testing, and specifications for past performance submissions. The solicitation (NB645030-25-01699) is for vialing reference material in Gaithersburg, with the government emphasizing specific technical constraints that limit alternative approaches proposed by potential vendors.

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File Type Posted
Revision Statement of Work.pdf PDF
Attch 1- Statement of Work_KY 082625.docx DOCX document
Attch 1- Revised Statement of Work_KY 082625.docx DOCX document
8671 14HB-D-001.pdf PDF
8671-MSDS .pdf PDF
Attch 5- QAs.xls XLS spreadsheet
Attch 4- Past Performance Questionnaire.pdf PDF
Attch 2- Provisions for Completion.docx DOCX document
Attch 3- Experience Project Data Sheet.docx DOCX document
Attch 1- Statement of Work.docx DOCX document
Final RFQ MAB VIALING 8.13.25.docx DOCX document
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Sheet1 - Table 1 - Table 1

Attachment 5- RFQ Q&A's
Question No.RFQ Attachment No.REFERENCEQUESTIONGOVERNMENT RESPONSE
PageSectionPara.
112III5Are there any specific label type requirements: i.e., freezer-bond, Cryogenic, chemical-resistant, etc?RFQ has been updated to include label requirements.
212III6&9Please clarify dispense volume per vial for task 1, there is a discrepancy +/-25ul vs +/- 50ulDispense volume shall be +/- 25 ul. RFQ has been updated.
312III9The RFP requires the use of a Thermo Matrix vial and rack system. Could an alternative be utilized? For example, Azenta tubes have all the necessary features compatible with RFP requirements. In addtion, the advantageous feature of having both 1D barcodes on the side of the vial and 2D barcodes on the bottom, eliminating the need for the laborious task of label printing and application.The Thermo Matrix vial and rack system has been evaluated for workflow requirements and suitability has been tested for NIST needs, while other systems have not. Printed labels are a requirement to meet the needs of NIST customers. The Thermo Matrix vial and rack system is the only system that can be used.
415IV3The RFP requires the purity of the monomeric molecule demonstrated through high-performance size exclusion chromatography. Could an alternative such as Agilent's Capillary Gel Electrophoresis System be utilized?High-performance size exclusion chromatography is required.
5RFQ4Quotation Preparation Instructions, Volume III8The RFP states the following requirement for Volume III Past Performance: "The offeror shall provide a past performance for a minimum of one (1) and a maximum of three (3) relevant projects identified for Factor II-Experience through either the submission of a completed Past Performance Questionnaire (Attachment 4) submission or in the form of a Contractor Performance Assessment Reporting System (CPARS) report."

If the offeror identifies three relevant contracts in the Experience Volume, are they required to provide a CPARS or Past Performance Questionnaire (PPQ) for all three contracts? One of our relevant contracts may pose a challenge in obtaining a PPQ from the client due to recent changes in the contract administrative staff. The number of past performance questionnaries does not have to equal the number provided in the experiece section.

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