D1 PD Purchase Description.pdf

Version 11-30-2016-1 FAR Part 11—Describing Agency Needs

PURCHASE DESCRIPTION

1. Name of Item or Project Title: Purchase of CombiFlash NextGen 300+ Automated

Flash Chromatography System with UV and ELSD detectors (Brand-Name or equal) with trade-in. This is a COVID-19 Action.

2. Statement of Need and Purpose: The National Center for Advancing Translational

Sciences (NCATS), Early Translation Branch (ETB) seeks to purchase one (1) automated flash chromatography system that is capable of purifying compounds based on both UV absorbance and, importantly, evaporative light-scattering detection (ELSD) to support the Antiviral Program for Pandemics (APP) with purification of small molecules from various medicinal chemistry programs.

3. Background Information and Objective: The National Institutes of Health (NIH) is the nation’s leading medical research agency and the primary Federal agency whose mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability, conducting, supporting and making medical discoveries that improve people’s health and save lives.

NCATS is one of 27 Institutes and Centers at the NIH and its mission is to catalyze the generation of innovative methods and technologies that will enhance the development, testing and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions.

The NCATS ETB mission is to uncover new small molecule therapeutics and advance the process of therapeutic development. Overall this project will support ongoing work for small molecule and combination screening, in silico virtual screening, nanobody/antibody design and optimization that are part of NCATS’s ongoing work to support the pandemic response.

NCATS has become a key partner in the Antiviral Program for Pandemics (APP), a multi-agency initiative that includes National Institute of Allergy and Infectious Diseases

(NIAID) and Biomedical Advanced Research and Development Authority (BARDA), to accelerate antiviral development through early discovery and preclinical development of safe and effective oral antivirals. The initial priority for the APP is to develop treatments for SARS-CoV-2 and other coronaviruses, with the program expanding to address other virus families with pandemic potential. NCATS will apply its proficiency in drug discovery and development and its cutting-edge technologies to fill critical needs of the APP, such as (i) target validation, (ii) high-throughput screening (HTS) for drug starting points, (iii) medicinal chemistry for lead optimization, and (iv) preclinical, investigational new drug

(IND)-enabling development.

Medicinal chemistry is essential to the development of probe molecules to test therapeutic hypotheses in disease-relevant models. It provides the starting point for all information in structure-activity relationship (SAR) studies and in the optimization of physicochemical/PK properties. Small molecule synthesis plays an important role in such SAR campaigns across all projects in the chemistry lab. The majority of organic syntheses require flash column chromatography for purification of compounds, which can be conducted in either ‘normal phase’ or ‘reverse phase’. During purification, flash chromatography instruments commonly detect eluting compounds based on ultraviolet light (UV) absorbance. However, when a compound of interest does not contain a chromophore (capable of absorbing UV light), detection must be done based on ELS.

Many intermediates and building blocks for medicinally relevant final compounds (as well as final compounds themselves) do not contain chromophores and as such, flash chromatography systems equipped with ELSD is an essential aspect of lab workflow.

Thus, CombiFlash NextGen 300+ Automated Flash Chromatography System with UV and ELSD detectors (Brand-Name or equal) is required for NCATS researchers and scientists to conduct new and ongoing research studies as well as for purification of small molecules from various medicinal chemistry programs in the APP initiative.

4. Generic Name of Product: Automated flash chromatography system with UV and evaporative light scattering detectors.

5. Brand-Name Purchase Description: For reference purposes, the automated flash chromatography system with with UV and evaporative light scattering detectors that meets the need of this requirement is the CombiFlash NextGen 300+ Automated Flash

Chromatography System with UV and ELSD detectors, as follows:

Part Number Description Quantity

685250001

CombiFlash NextGen 300+ Automated Flash Chromatography System, UV detector 200-400 nm with

PeakTrak software control via 12" capacitive touchscreen.

Flow rate range of 1-300mL/min. Maximum pressure limit of 300psi (20bar) Automated solid load injection valve. RFID rack and column read. Automatically loads column method information and writes back run information to the column.

Automatically loads rack configuration. Active solvent level sensing One set of collection racks (quantity 2):

----- 117V - (140) 18x150mm test tubes (Standard) -----234V - (150) 16x150mm test tubes (Standard)

1 ea

605257001 ELSD Upgrade for CombiFlash NextGen 300 and 300+;

Factory Installed 1 ea

605237048

Adjustable Solid Load Cartridge Cap (SLCC), fits 12 and 25 gram-size sample load cartridges. Includes one loading rod.

Compatible with the Combiflas Rf or NextGen and EZPrep system. Optional accessory for NextGen system or EZPrep system.

1 ea

Shipping, Handling, and Installation 1 ea

12 months warranty 1 ea

6. Salient characteristics The salient characteristics of the Automated flash chromatography system with UV and evaporative light scattering detectors include:

• Be automated and contain both a UV detector (200-400nm) and ELSD.

• Be compatibile with both liquid and solid loading.

• Have a flow-rate from 1-300 mL/min with a maximum pressure of at least 300 psi.

• Be compatible with current lab test tubes and test tube racks (wracks built by Teledyne).

• Handling and Shipping to NCATS, FOB Destination.

• Installation.

• Twelve (12) months warranty on the instruments after installation.

7. Quantity: One (1) CombiFlash NextGen 300+ Automated Flash Chromatography

System with UV and ELSD detectors (Brand-Name or equal), as provided in the

Purchase Description.

8. Delivery Date: Delivery is required within ninety (90) days after receipt of order (ARO).

Delivery shall be made to the below address with FOB Destination.

National Center for Advancing Translational Sciences (NCATS)

9800 Medical Center Drive

Building and Room for installation to be provided at award.

Rockville, MD 20850

The installation shall be conducted on dates and times agreed upon by the vendor and the NCATS point of contact designated on the award, no later than thirty (30) days after installation.

9. Trade-in: The quoter must take into consideration the following trade-in equipment when providing a quote in order to offers a discount to the purchase price of the new property in exchange for the old, similar property:

Item Description: The CombiFlash Rf+ is a UV based automated flash chromatography normal phase purification system

Model: CombiFlash Rf+

Manufacturer: Teledyne ISCO

Serial # 214G20021

Condition: Good

Location of the Equipment: NCATS, C2 chemistry lab at 9800 Medical Center Drive

Rockville, MD 20850