This is a Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources to perform a potential requirement. For equipment/supply requirements, responses must include: (1) the place of manufacturing (i.e. address if supply/equipment is a domestic end product and include country of manufacture), as well as (2) the size status of the manufacturer under the applicable NAICS code (i.e. address Non-Manufacturer Rule). This notice is issued to help determine the availability of qualified companies technically capable of meeting the Government requirement and to determine the method of acquisition. It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract. Responses will not be considered as proposals or quotes. No award will be made as a result of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this notice. This notice is strictly for research and information purposes only. Background: The National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH) develops new candidate drugs for individuals with rare and neglected disease, and HEAL and APP projects. NCATS’ facilitates drug discovery from the basic research lab to the pre-clinical stage, concentrating its efforts on the pre-clinical stage of drug discovery and development. In doing so, NCATS will help bridge the wide gaps in time and resources that often exist between basic research and clinical testing of new drugs. Liquid Chromatography (LC) and Mass Spectrometry (MS) capability is required in order to conduct the necessary comprehensive pharmacokinetic (PK) analysis of drug candidates. The LC-MS instrumentation will allow the Drug Metabolism & Pharmacokinetics Core Lab to further characterize drug candidates’ ADME properties. The procurement of the LC-MS instrumentation will bring the Drug Metabolism & Pharmacokinetics Core Lab up to current standards which will provide the group with more accurate and reliable results. Purpose and Objectives: Trade in of Xevo TQ-S and Exion UPLC for ADME. To replace and trad-in the 10 yrs old Waters UPLC-MS/MS instrument with a new unit. This instrument is used daily in the lab to quantify drug concentrations in biological samples collected from pharmacokinetic studies. The salient physical, functional, or performance characteristics that “equal” products must meet are specified in the purchase description below. Purchase Description: Waters Xevo TQ Absolute w/ Acquity Premier and Andrew+ Robot Procurement Salient characteristics: The following salient characteristics are necessary for the requested supplies: All components of the system and software shall be manufactured and serviced by the same company/organization. In order to conduct the proper PK analyses of drug candidates in various matrices and improve sample recovery, the UPLC system must have the following capabilities: • Shall have biocompatible and inert, including High Performance Surfaces (HPS) Ultra-Performance Liquid Chromatography sample introduction systems to include pumps with integrated degassers, flow through needle autosamplers, and column compartments. This will improve separation and detection of metal-sensitive analytes by mitigating non-specific binding. Such analytes include organophosphates, oligonucleotides, peptides, and phospholipids. This will improve the detection of previously undetected analytes and increase efficiency by eliminating time consuming system and column passivation. • The sample manager shall be able to accommodate at least ninety six (96) of the standard 2-mL vials or >2 microplates (96 or other wellplates), and be optionally extended to accommodate a total of 21 well-plates. The sample manager must have primary and secondary fluidic paths that are made of biocompatible and inert materials including HPS. • The column manager compartment shall support independently controlled temperature zones for each of the individual columns and the flow path must have HPS technology (or equivalent) as found in the MaxPeak HPS columns. • Shall be able to support eCord Technology which documents the methods and usage of Acquity UPLC columns, up to 50 sample sets, the minimum and maximum pressure and temperature, sample and injection totals for the column can be stored and accessed using Acquity UPLC system console software. The eCord must be part of each individual column for traceability. • The software: Shall run on Windows 10 operating systems. Shall provide a single point of control for all of the LC/MS/MS system’s components, features, and functionality and allow data processing concurrent with sample analysis. Shall be able to run at the same time as other programs on the computer such as Spreadsheet software. In order to conduct the proper chemical analyses of drug candidates in various matrices and offer the lowest limits of detection possible the mass spectrometer system must have the following capabilities: • The mass spectrometer MRM sensitivity (ESI+) for a 1 pg on-column injection of reserpine must give a chromatographic signal-to-noise greater than 3,000,000:1, using raw unsmoothed data (Gradient separation, LC mobile phase flow rate of 0.6 mL/min, MRM transition m/z 609 > 195). The Instrument Detection Limit (IDL) from ten replicate injections must be calculated to be less than 0.2 fg reserpine • The mass spectrometer MRM sensitivity (ESI-) for a 1 pg on-column injection of chloramphenicol must give a chromatographic signal-to-noise greater than 3,000,000:1, using raw unsmoothed data (Gradient separation, LC mobile phase flow rate of 0.8 mL/min, MRM transition m/z 321 > 152). The Instrument Detection Limit (IDL) from ten replicate injections must be calculated to be less than 0.2 fg chloramphenicol • The mass spectrometer should have width of less than 450 mm to allow use in the laboratory where space is limited. • The mass spectrometer system power consumption (including the mass spectrometer, rough pump and data system) should be less than 2000 W during routine use to reduce heat production and lessen the air conditioning burden on the laboratory. • The mass spectrometer must have UniSpray Ion Source capabilities. This atmospheric pressure ion source provides increased ionization efficiency and desolvation characteristics compared to ESI as well as a broader compound coverage than either ESI, APCI or APPI alone. This is important for detection of difficult analytes. • The mass spectrometer must have a mass range of 2 to 2,048 m/z. • The software: Shall run on Windows 10 operating systems. Shall provide a single point of control for all of the LC/MS/MS system’s components, features, and functionality and allow data processing concurrent with sample analysis. Shall be able to run at the same time as other programs on the computer such as Spreadsheet software. In order to improve sample preparation by reducing human error and offering greater flexibility of an automation device the pipet robot must have the following capabilities: • The pipet robot must have the ability to be placed into a laminar flow hood or biosafety cabinet to support use under sterile conditions. The robot must have dimensions of 42” W x 24” H x29” D when not in use to accommodate space requirements for storage. • The pipet robot must be remote controllable be able to be used with any PC or laptop and viewable with a web browser. • The pipet robot’s liquid handling capabilities need to support a range 0.2uL to 10mL to accommodate diverse sample preparation needs. It must also support Bluetooth-enabled electronic pipettes sourced from Sartorius. Xevo TQ Absolute System with the following configuration - 1 Xevo TQ Absolute on MassLynx - 1 MS Ref StdsXEVO TQ-XS - 1 Dry Vacuum pump - 1 API UniSpray Source - 1 MassLynx Performance Workstation with TL - 1 Monitor, 27" - 1 ACQUITY Premier BSM/FTN - 1 ACQ Premier Col Mgr Active 2 Col (CM-A) - 1 ACQUITY UPLC SO H/I-Class - 1 XEVO Tandem Quad System Install Cert. - 1 NA - Professional Srv Training - 3 Days - 1 Analytical LC-MS Solvent Install Kit - 1 System Disposal-Waters - 1 UPLC/HPLC SYSTEM & SOFTWARE INSTALLATION - 1 Trade in - to include: - 1 Xevo TQ-S - s/n WAA246 Exion UPLC - s/n AB3AD5875089 Andrew Alliance Systems with the following configuration - 1 Andrew+ Pipetting Robot w/Licence - 1 The Andrew+ Start Up Kit - 1 Single channel AA pipette 5-120 uL - 1 8-Channel Pipette (5-120 uL) - 1 8-Channel Pipette (10-300 uL) - 1 Storage Plate Domino - 3 Deepwell Microplate Domino - 3 8-Channel Reservoir (50 PCK) - 1 Andrew+ Robot System Installation Cert. - 1 Andrew+ Standalone server - 1 Single channel AA pipette 50-1000 uL - 1 Single Channel Pipette (100-5000 uL) - 1 BH Tip 0.5-200 uL, Refil (10x96) - 1 BH Tip 100-5000 μl, ST (1x50) - 1 BH Tip 100-5000 μl, ST (1x50) - 1 Pipette Adaptor Single Channel - 1 Implementation Kit - 2 Delivery Date: Within 60 days after receipt of order Capability statement /information sought: Respondents must provide clear and convincing documentation of their capability of providing the equipment specified in this notice. The respondent must also provide their UEI number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HubZone, etc., pursuant to the applicable NAICS code and any other information that may be helpful in developing or finalizing the acquisition requirements. One (1) copy of the response is required and must be in Microsoft Word or Adobe PDF format using 11-point or 12-point font, 8-1/2” x 11” paper size, with 1” top, bottom, left and right margins, and with single or double spacing. The information submitted must be in an outline format that addresses each of the elements of the service requirement and in the capability statement /information sought paragraphs stated herein. The response must include the respondents’ technical and administrative points of contact, including names, titles, addresses, telephone numbers, and e-mail addresses. All responses to this notice must be submitted electronically to the Contract Specialist. Facsimile responses are NOT accepted. The response must be submitted to Morgen Slager, at e-mail address
[email protected] with the subject line 75N95022Q00315SS . The response must be received on or before June 28, 2022, 11:00 am, Eastern Time. Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in SAM.gov. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).