Inactive

Amendment 2: The purpose of this Amendment is to provide a 2 week extension to the current quotation due date of August 30, 2024. All quotations are now due no later than 12:00PM EST, on September 13,... Amendment 2: The purpose of this Amendment is to provide a 2 week extension to the current quotation due date of August 30, 2024. All quotations are now due no later than 12:00PM EST, on September 13, 2024. End of Amendment 2. ___________________________________________________________ Amendment 1: The purpose of this Amendment is to provide Government responses to the timely submitted vendor questions below: 1. Vendor Question: Is there reference material available to determine the critical quality attributes (e.g. glycosylation profile) prior to initiation of the work? Government Response: NIST will provide information on the critical quality attributes of the material upon award of the purchase order as outlined in the Statement of Requirement, after the kick-off meeting. 2. Vendor Question: What is the highest consistent titer seen in the current 2L scale bioprocess? Government Response: 2 g/L End of Amendment 1. ___________________________________________________ DESCRIPTION: THIS IS A COMBINED SYNOPSIS/SOLICITATION FOR COMMERCIAL PRODUCTS OR COMMERCIAL SERVICES PREPARED IN ACCORDANCE WITH THE FORMAT IN FAR SUBPART 12.6-STREAMLINED PROCEDURES FOR EVALUATION AND SOLICITATION FOR COMMERCIAL ITEMS-AS SUPPLEMENTED WITH ADDITIONAL INFORMATION INCLUDED IN THIS NOTICE. THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION; QUOTATIONS ARE BEING REQUESTED, AND A SEPARATE WRITTEN SOLICITATION WILL NOT BE ISSUED. THE SOLICITATION IS BEING ISSUED USING SIMPLIFIED ACQUISITION PROCEDURES UNDER THE AUTHORITY OF FAR PART 13.5 SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL ITEMS. This solicitation is a Request for Quotation (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2024-05 dated May 22, 2024. The associated North American Industrial Classification System (NAICS) code for this procurement is 541714 Research and Development in Biotechnology (except Nanobiotechnology) with a small business size standard of 1,000 employees. This acquisition is being solicited as an unrestricted full and open competition. Contractors must possess an ACTIVE registration in the System for Award Management system, www.SAM.gov, when submitting a quotation and shall continue to be registered until time of award, during performance, and through final payment of any contract resulting from this solicitation. The Contracting Officer will confirm that quoters have an “active” registration at the www.sam.gov website upon receipt of the quotation. If the SAM.gov registration is not active, the quotation will not be considered for award. BACKGROUND: The Biomolecular Structure and Function (BSF) group in the Biomolecular Measurement Division of the Materials Measurement Laboratory at the National Institute of Standards and Technology (NIST) intends to develop a monoclonal antibody expressed from the National Institute of Standards and Technology Chinese Hamster Ovary (NISTCHO) reference cell line as a NIST Reference Material (NIST RM). The material is intended to be highly representative of Chinese Hamster Ovary (CHO)-expressed monoclonal antibodies used as biopharmaceuticals. This reference material is planned to be a companion molecule to both the NISTmAb (RM 8671) monoclonal antibody reference material (reference product) and the NISTCHO (RM 8675) cell line reference material (non-originator expressing cell line). As such, the BSF group intends to contract the manufacturing of a monoclonal antibody expressed from the NISTCHO cell to an organization capable of performing such manufacture and characterization to include key features of GMP (Good Manufacturing Practice) manufacturing to enable a comparable production process and similar quality attributes (commonly referred to as “GMP-like”). This material will be released with quantitative data traceable to fundamental units of measurement and is expected to be utilized as a system suitability tool in the biopharmaceutical industry. The objective of this solicitation is to establish a Firm-Fixed-Price purchase order based on the specifications described in the attached Statement of Requirements (SOR). All Contractors shall provide a firm-fixed-price quotation for the following line item(s): CLIN 0001: Nominally 1 kilogram (kg) of purified monoclonal antibody in accordance with the Statement of Requirements. Date(s) and place(s) of delivery and acceptance and FOB point are required in accordance with the attached Statement of Requirement document. Due Date for Quotations and Questions All quotations must be submitted, via e-mail, to the Contract Specialist, Sadaf Afkhami, at Sadaf.Afkhami@nist.gov, with a carbon copy to the Contracting Officer, Donald Graham at Donlad.Graham@nist.gov. Submissions must be received no later than 12:00 p.m. Eastern Time on September 13, 2024. FAX quotations will not be accepted. Quoters must reference the RFQ number in the subject line of the e-mail submission. Quotes shall not be deemed received by the Government until the quotation has entered the e-mail inbox of the individual(s) set forth above. Questions: All questions regarding this notice must be submitted via e-mail to the Contract Specialist, Sadaf Afkhami, at Sadaf.Afkhami@nist.gov, with a carbon copy to the Contracting Officer, Donald Graham, at Donlad.Graham@nist.gov, no later than 12:00 p.m. Eastern Time on August 20, 2024. All responses to the questions will be made in writing, without identification of the questioner, and will be included in an amendment to the solicitation. Even if provided in other form, only the responses included in the amendment to the solicitation will govern performance of the contract. Please reference the solicitation number in the subject line of email communications. Quotation Preparation Instructions: Each quotation shall consist of six (6) separate electronic files (in PDF format). In preparing the quotation, each electronic file shall stand on its own. For each given evaluation factor the Government will only evaluate the information provided in the corresponding section of the quotation. The Contractor’s quotation shall be clearly divided into the following six (6) files: Technical Quotation Experience Past Performance Price Quotation Provisions and Clauses Small Business Subcontracting plan 1. Technical Quotation: The technical quotation shall address the following: Technical Approach: The Contractor shall provide a detailed technical approach to each requirement in the SOR which shall include information demonstrating their overall understanding of the requirements and the complexity of developing and maintaining libraries, how the requirements will be met, and the means used to accomplish them. Additionally, the contractor shall provide information on delivery timeline for the deliverables, how the project is to be organized, staffed, and managed that demonstrates the Contractor’s understanding and effective management of important events or tasks. The Contractor must not simply state they will meet or exceed the requirement; evidence must be provided. 2. Experience The Contractor shall provide detailed information on their organization’s experience providing services similar to those listed in steps 1 through 3 in the SOR. The provided information must include a background description of the previous experience. 3. Past Performance The Contractor shall provide past performance information regarding up to five relevant contracts for the past three years with federal, state or local governments, and international and commercial customers. The information shall describe contracts of a similar type and scope as the current requirement. If the Contractor has no relevant past performance it must include a statement to that effect. The government reserves the right to consider data obtained from sources other than those described by the Contractor in its quotation. For each contract/order, the Contractor shall provide the following information: Contract number; Description and relevance to solicitation requirements including dollar value; Period of Performance – indicate by month and year the state and completion (or “ongoing”) dates for the contract; Reference Contact – If a non-Government contract, identify the name and address of the client with current telephone number and email address of a point of contact of the client responsible for the contract; Contracting Office – If a Government contract (Federal or state), identify the Contracting Officer (CO), and Contracting Officer’s Representative (COR), and their names, current telephone numbers and email addresses. Problems Encountered – include information regarding any problems encountered on the contracts described above and corrective actions taken to resolve those problems. 4. Price Quotation: The pricing quotation shall be separate from any other portion of the quotation. The Contractor shall submit a firm-fixed-price quotation for each CLIN to include all shipping/delivery costs. The price quotation shall include a cover page with the following information: The solicitation number 1333ND24QNB640640; The name and address, of the Contractor; The name, phone number, and email address of the Contractor’s point of contact; The Unique Entity ID # for Contractor’s active SAM.Gov registration. Any applicable discount terms. A statement that the Contractor agrees to all terms, conditions, and provisions included in the solicitation. If the Contractor objects to any of the terms and conditions contained in this solicitation, the Contractor shall state “The terms and conditions in the solicitation are acceptable to be included in the award document with the exception, deletion, or addition of the following:” [Contractor shall list exception(s) and rationale for the exception(s)]. It is the sole responsibility of the Contractor to identify in their quote any exceptions to the terms and conditions of the solicitation. A statement that the quotation is valid for a minimum of 90 days from the response deadline of this solicitation. 5. Provisions and Clauses The provisions and clauses applicable to this solicitation are identified in Attachment 2 titled “Provisions and Clauses”. Contractors shall provide a completed copy of all provisions highlighted in blue in the attached Provisions and Clauses document (Attachment 2). 6. Small Business Subcontracting Plan Contractors must submit a copy of their Small Business Subcontracting Plan. The plan will be reviewed but will not be used as part of the evaluation for award. EVALUATION CRITERIA The Government intends to award a single firm fixed price purchase order (PO) from this solicitation to the responsible Contractor whose quotation, conforming to the solicitation is found most advantageous to the Government, price and other factors considered. The Government will evaluate quotations based on the following evaluation criteria factors: 1) Technical Approach; 2) Experience; 3) Past Performance and 4) Price. Nonprice factors, when combined are more important than Price. A Contractor's failure to address any factor may be considered indicative of the Contractor's lack of understanding of the Government's requirements and may result in the quote being determined unacceptable. Evaluation Factors: Factor 1- Technical Approach: Evaluation of the technical approach shall be based on the information provided in the technical quotation. The Government will evaluate the Contractor’s understanding of the requirements described in the SOR and the complexity of producing monoclonal antibodies; the extent to which its technical approach to the SOR demonstrate its ability to provide the required services; and any risks associated with its technical approach, project organization, and staffing. Quotations that do not demonstrate that the Contractor can meet all requirements, will not be considered further for award. Factor 2- Experience The Government will evaluate the Contractor’s experience to determine the extent to which the general background, experience, and qualifications demonstrate its ability to perform the requirements described in the SOR. Potential contractors shall include experience with the following (if applicable): - CHO cell lines and manufacturing of monoclonal antibodies o CHOZN platform o NISTCHO RGTM 10197 - Scale up and manufacturing at the 200L scale and above - Process Development - Homogenization of large batches (minimum 10L scale) Factor 3- Past Performance In assessing the Contractor's past performance information, NIST will evaluate, as appropriate, (b) successful performance of contract requirements, quality and timeliness of delivery of goods and services, (c) communications between contracting parties, (d) proactive management and customer satisfaction. Evaluation of this factor will be based on information contained in the past performance portion of the quote, CPARS, and information provided by references. The Government will evaluate past performance information by contacting appropriate references, including NIST references, if applicable. The Government may also consider other available information in evaluating the Contractor’s past performance. The Government will assign a neutral rating if the Contractor has no relevant past performance information. Factor 4- Price: The proposed price will be evaluated. The evaluation will determine whether the proposed prices are reasonable in relation to the solicitation requirements. Prices must be proportionate with the technical portion of the quotation. Please note that this procurement IS NOT being conducted under the GSA Federal Supply Schedule (FSS) program or another Government-Wide Area Contract (GWAC). If a contractor submits a quotation based upon an FSS or GWAC contract, the Government will accept the quoted price. However, the terms and conditions stated herein will be included in any resultant Purchase Order, not the terms and conditions of the contractor’s FSS or GWAC contract. PROVISIONS AND CLAUSES: The provisions and clauses applicable to this solicitation are identified in Attachment 2 titled “Applicable Clauses & Provisions”. The full text of a Federal Acquisition Regulation (FAR) provision or clause may be accessed electronically at www.acquisition.gov/far. The full text of a Department of Commerce Acquisition Regulation (CAR) provision or clause may be accessed electronically at https://www.acquisition.gov/car. ATTACHMENTS: The following attachments apply to this solicitation: 1. Attachment 1- Statement of Requirement 2. Attachment 2- Provisions and Clauses