Acquisition of research grade (>98% pure) trityl radical derivative, Oxo63 for in vivo Electron Paramagnetic Resonance Imaging
General Information
Short Title: Acquisition of research grade (>98% pure) trityl radical derivative, Oxo63 for in vivo Electron Paramagnetic Resonance Imaging.
Document Type: Special Notice
Solicitation Number: 75N91019Q00086
Posted Date: 7/11/2019
Response Date: 7/22/2019
Classification Code: 6850 - Miscellaneous Chemical Specialties
NAICS Code: 325199 - All Other Basic Organic Chemical Manufacturing
Contracting Office Address
Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E232 Bethesda, MD 20892, UNITED STATES
This acquisition will be processed under FAR Part 12 - Acquisition for Commercial items and will be made pursuant to the authority in FAR 13.106-1(b)(1) using simplified acquisition procedures for commercial items. The North American Industry Classification System code is 325199 and the business size standard is 1,250 employees.
Only one award will be made as a result of this solicitation. This will be awarded as a firm fixed price type contract.
It has been determined there are no opportunities to acquire green products or services for this procurement.
Description
The rapid uncontrolled growth of cancer cells requires a different metabolism than the steady, controlled growth of normal cells. This results in abnormal vasculature resulting in poor tumor perfusion and oxygenation resulting in tumor hypoxia. Hypoxic tumors display resistance to radiation. Pre-treatment status of tumor oxygenation will be useful in the choice of optimal therapy. EPR Imaging is the only imaging technique which can obtain maps of tissue oxygenation non-invasively and quantitatively with good spatial and temporal resolutions. Further work will help translate this modality for human use.
There are several paramagnetic tracers which can be used for in vivo assessment of tissue oxygen quantitatively. Nitroxide radicals, LiPc, trityl radicals have all been used for in vivo applications. One of the tracers used for EPR imaging, Oxo 63 is safe and has the pharmacologic and toxicologic profile for use in pre-clinical research on mouse models of human cancers. It has been extensively used in imaging experiments with mice. It has already been used in humans at lower doses in hyperpolarized MRI. It is now necessary to use this agent in larger animals such as rats, dogs, and pigs to get information needed to translate to humans.
Over several years, CCR has been using Oxo63 as the paramagnetic tracer for in vivo EPR imaging experiments to study the physiology of tumors implanted in mice. Of all the paramagnetic tracers Oxo 63 ((tris[8-carboxy-2,2,6,6-tetrakis(2-hydroxymethyl)benzoyl[1,2-d']bis(1,3)dithio-4-yl]methyl radical) is a tracer CCR has been using since 2000 in all of the small animal imaging studies. This compound is a patented product and available from only GE Healthcare. CCR has acquired this material from GE in the past. The material obtained was of high purity and with all the chemical analyses and authentications. Also, this material comes certified with the Material Safety data sheet. Acquiring this material ensures continuity in CCR's experimental research. NCI has made the choice of using this molecule based on its long pharmacologic half-life, low toxicity at the doses needed for imaging, optimal spectral features. Several experiments in mouse models of human cancers have revealed that pre-treatment assessment of tumor physiology in terms of absolute measurement of tumor pO2, its dynamics and changes in response to treatment provided valuable information in the choice of treatment based on tumor pO2. Now it is appropriate to study larger objects such as rats, rabbits, pigs, and dogs with this technique to obtain information needed to evaluate this technology for human use. Larger animals entail usage of this agent at doses larger than that used in mice.
An amount of 25 Grams of Oxo 63 is needed. The product should have water solubility at 100 mM and spectral features needed for detection by EPR imaging such as oxygen dependent line widths in the range of 200 - 500 mG.
The following product features/characteristics are required for this requirement, inclusive of hardware and/or software:
• An amount of 25 grams of Lyophilized powder of Oxo 63 ((tris[8-carboxy-2,2,6,6-tetrakis(2-hydroxymethyl)benzoyl[1,2-d']bis(1,3)dithio-4-yl]methyl radical), at a >98% purity in individual vials of 100 mg.
• A Certificate of Analysis pertaining to the purity and stability.
• Shipping charges must be included in the quote. NCI will not be responsible in the event charges are not included in the quote.
Note: NCI plans to award a contract that has FOB origin delivery terms
To NCI's knowledge, Oxo63 is a chemical material available only from GE Healthcare since it is covered by their patents. GE has supplied this material in prior years-most recently in 2013-which has been used for all the imaging studies. Hence getting this material from GE Healthcare ensures continuity with material prepared under identical conditions. Thus, the proposed vendor is the sole source that can meet the needs of this requirement.
This notice is not a request for competitive quotation. However, if any interested party, especially small businesses, believes it can meet the above requirement, it may submit a capability statement, proposal, or quotation, which shall be considered by the agency. The statement of capabilities and any other information furnished must be in writing and must contain material in sufficient detail to allow NCI to determine if the party can perform the requirement. Responses must be received in the contracting office by 12:00 PM EST, on July 22, 2019. All responses and questions must be in writing and faxed 240-276-5401 or emailed to David Romley, Contract Specialist OR via electronic mail at david.romley@nih.gov. A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. No collect calls will be accepted. In order to receive an award, contractors must be registered and have valid certification in the System for Award Management (SAM) through sam.gov. Reference: 75N91019Q00086 on all correspondence.
David H. Romley, Contract Specialist, Phone 2402767822, Email david.romley@nih.gov
