Trasis All in One radiosynthesizer and HPLC with installation and training

Title: Trasis All in One radiosynthesizer and HPLC with installation and training
Document Type: Special Notice
Solicitation Number: 75N91019Q00096
Posted Date: 07/11/2019
Response Date: 07/18/2019
Classification Code: 6640- Laboratory Equipment and Supplies
NAICS Code: 541690 -- Other Scientific and Technical Consulting Services
Business Size: 15 Million

Contracting Office Address:
Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E128, Bethesda, MD 20892, UNITED STATES.

Description:
National Cancer Institute (NCI), is seeking sources that can provide a Trasis All in One radiosynthesizer and HPLC. The requirement includes the instrument, installation and training. The equipment will be used for clinical PET radiolabeling doses for the clinical trial patients in the Molecular Imaging Program (MIP) from IPharmaSupport at 12810 Tutor Lane, Houston, Texas 77077.

The response close date of this notice for this requirement is in accordance with FAR 5.203(a)(1). 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 acquisitions and is exempt from the requirements of FAR Part 6. The North American Industry Classification System code is 541690 and the business size standard is $15M.

The mission of the Molecular Imaging Program (MIP) is to develop new imaging agents for cancer and translate them into human patients. The MIP conducts research in designing, developing and testing new novel targeted imaging agents for the detection and characterization of cancer. These imaging agents include tissue-specific MRI, Positron Emission Tomography (PET), radionuclide, and optical probes. The MIP focused on the clinical translation of targeted imaging agents for cancer imaging.

Over the past few years the regulatory standards for translation and good manufacturing practice (GMP) manufacture have become stricter. A major breakthrough in GMP production technology is the Trasis All in One box. Instead of manually setting up the synthesis this box enables "cassettes" custom designed for each probe. The cassettes include their own HPLC such that the box can almost immediately be reused thus dramatically improving the productivity of the lab. This will impact the MIP by allowing it to produce more of the probes already produced in PET and be able to introduce new agents more quickly into the clinic.

This will be awarded as a severable firm fixed price type contract. The award will be in the aggregate.

It has been determined there are no opportunities to acquire green products or services for this procurement.

This will enable MIP to fulfill its mission of bringing new imaging agents and potentially therapeutic agents to the clinic.

The following products are required to fulfill the NCI MIP requirement:

1. Trasis Product Number 7115
- All in One (AIO) 18: Synthesizer with 18 rotary actuators
2. Trasis Product Number 7561
- Upgrade from AIO 18 to AIO 24
3. Trasis Product Number 7565
- Option AIO: Built-in UV sensor with variable wavelength
4. Trasis Product Number 7564
- Built-in radio HPLC for AIO
Additionally, NCI MIP requires installation and remote training which includes:

- Onsite installation
- Factory Acceptance tests: IQ+OQ (Results will be used to accept the equipment)
- Calibration
- Remote training 2 hours before the installation and 2 hours after installation
- Training for daily operations with hot runs for one Ready to use tracer.

SPECIAL ORDER REQUIREMENTS

PRODUCT FEATURES/SALIENT CHARACTERISTICS

The following product features/characteristics are required for this requirement:

• The Trasis All in One and HPLC must be compatible with current Trasis systems installed in the Clinical Center PET department
• Must have twenty-four (24) servomotor actuators for up to 24 cassette valves (must have the option for field modification to 36 servomotor actuators
• Must have two heaters (up to 220 oC;; optional cooling down to -40 oC) for reaction vessels (must have the option for field modification of an one (1) additional external heater
• Must have five servomotor syringe actuators (each shall accommodate 1, 3, 10 or 20 mL
• Must have vacuum and controllable from 50mbar to 1 bar absolute
• Must have pressure (Nitrogen; must be controllable from 1 bar to 5 bar abs)
• Must have User interface-controlled external I/Os
• Must have connection that allows collection of chemistry exhaust gas that may be potentially radioactive.

• Must have integral HPLC with injection valve and loop, column selection valve, shielded radio HPLC detector, manual and automatic radio-fraction collection and variable UV HPLC detector. HPLC includes HPLC pump and eluent selection module.

• Cassettes must be constructed in units of 6 valves. Each unit of 6 valves must be joined to comprise an array of up to 18 valves (6 or 12 or 18).

• All components must be compatible with the most aggressive acids, bases and solvents even at elevated temperatures.

• Cassettes shall be comprised of inert materials (such as TPX Polymethylpentene polymer) and be chemically compatible with: DMSO, THF, toluene, dichloromethane, etc., Strong mineral acids HCl, HBr and HI, and temperatures up to 140°C.

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 the NCI to determine if the party can perform the requirement. Responses must be received in the contracting office by 3:00PM EDT, on July 18, 2019. All responses and questions must be in writing and faxed (240) 276-5433 or emailed to William Neal, Contracting Officer via electronic mail at william.neal@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, current Entity Record, including current Representations and Certifications, in the System for Award Management (SAM) through SAM.gov. Reference: 75N91019Q00096 on all correspondence.

.