****Please read the attachment for the full RFQ****** Background Several companies are seeking to participate in Center for Drug Evaluation and Research (CDER)’s Emerging Technology Program, to manufacture biosimilars and New Molecular Entity (NME) biologics using continuous manufacturing (CM) and single use technologies. The limited knowledge on the risks of CM and single use technologies on the quality of biotech products necessitates expanded research in this area. The Division of Product Quality Research (DPQR) is establishing a continuous platform for a biologic produced by a Chinese Hamster Ovary (CHO) cell line. A bioreactor will be operated for extended durations of time (≥25 days) under perfusion mode and will utilize several other supporting instruments and systems to enable drug substance production up to a capture step. A significant amount of process data will be generated from bioreactor, perfusion system, nutrient analyzer, autosampler, protein purifier and any other system which could be included later to facilitate CM. A centralized data acquisition and management software is essential for successful CM campaigns and future data analysis. Biologics manufacturing data management software, such as MYstro, is Commercial Off the Shelf software that is available to meet our data management requirement for the CM and future analysis of the CM campaign performances. Objective To purchase one (1) MYstro software, brand name or equal, with a computer and monitor and other required IT accessories to integrate data acquisition and management from different components of the CM campaigns. 3. Instruction to Quoters This solicitation is issued under FAR Part 12 and 13.5 procedures. This is an unrestricted procurement. The NAICS code is 541519. Quoters responding to this RFQ must be registered with an Active status in the System for Award Management (SAM): www.sam.gov. Quoters shall certify their quotes to be valid for 30 days. Quoters shall be Original Equipment Manufacturers, authorized resellers and/or servicing agents of the software manufacturer. Quoters should ensure that all information is provided to determine technical acceptability and that their initial submission represents their best pricing. The Government will not research items to determine compatibility; all information regarding compatibility must be contained within the quotation. Quotations must meet all the requirements of this solicitation in order to be considered technically acceptable. Quoters shall submit all assumptions in their quotation. All Quoters providing quotations must clearly state the overall cost to the Government. Quoters shall submit a complete pricing for all products listed in this RFQ. Partial quotes will not be considered. Incomplete pricing or pricing with omissions may not be considered for award. Equal To quotations must submit Technical volume with detailed point-by-point description of how the equal to product meets all the salient characteristics of this solicitation. Equal to Quotations shall be required to operate seamlessly with connecting operating software and/or hardware. Equal To solutions shall include a breakdown of all costs associated with the integration of the proposed solution into FDA environment. These costs shall be incorporated in the overall cost to the Government. For equal to quotations, Quoters will submit Section 508 Product Accessibility Templates (PAT) in full text with their quotations. For more information regarding PATs see: http://www.hhs.gov/web/section-508/contracting/technology-products/product-accessiblity-template/. Please submit questions to Min Jie (Terry) Zeng via email at
[email protected] no later than 12PM Eastern Time on June 10, 2020. Please submit quotes to Min Jie (Terry) Zeng via email at
[email protected] no later than 12PM Eastern Time on June 19, 2020. 4. Evaluation Criteria The Government shall award a contract resulting from this solicitation to the responsible quoter as a fixed‐price contract on the lowest price technically acceptable (LPTA) evaluation method. Award will be made on the basis of the lowest evaluated price meeting or exceeding the non‐cost factor (technical conformance to the requirements of the solicitation). The Quoter’s initial quotation should contain the Quoter’s best terms from a price standpoint. Failure to demonstrate meeting any of the requirements will result in a rating of technically unacceptable and will not be considered for award.