Attch.1_SON_RFQ75N91024Q00054.pdf

STATEMENT OF NEED (SON)

1.0 TITLE

Acquisition of One (1) Brand Name or Equal Diagenode Bioruptor Plus Tabletop Bath Sonicator

2.0 BACKGROUND

The National Cancer Institute (NCI), Center for Cancer Research (CCR), Laboratory of Molecular Biology (LMB) conducts pre-clinical and clinical research to understand biochemical processes and to develop antibody-based agents for the treatment of various cancers. LMB is currently conducting clinical trials to evaluate the immunotoxin Moxetumomab pasudotox for treatment of Hairy Cell Leukemia (HCL). To determine the genetic mutations, gene expression changes, and cellular processes contributing to disease development and treatment resistance, it is necessary to extract DNA, RNA, and proteins from leukemic cells. In another project, LMB is developing lipid-based nanoparticles for chemotherapeutic drug delivery. This requires forming lipid vesicles through the application of ultrasonic sound waves. To accommodate both projects, and others LMB requires a tabletop bath sonicator that can be used for DNA and RNA shearing, tissue and cell disruption, DNA, RNA, and protein extraction, protein aggregation, and lipid vesicle formation. The LMB previously utilized a Diagenode Bioruptor instrument for these applications, but recently it stopped functioning and is unable to be repaired. Therefore, LMB requires the purchase of a new bath sonicator. To maintain the integrity of LMB’s research and the continuity of our results, we require a bath sonicator that performs to the same specifications, or better, than the old Bioruptor, in terms of sonication efficiency and reproducibility.

3.0 BRAND NAME OR EUQAL

This requirement is for one (1) Brand Name or Equal Diagenode Bioruptor Plus. The Federal Acquisition Regulation (FAR) provision 52.211-6 Brand Name or Equal (AUG 1999) is applicable to this requirement.

4.0 TYPE OF ORDER

This is a Firm Fixed-Price Purchase Order.

5.0 SPECIAL ORDER REQUIREMENTS

5.1 PRODUCT FEATURES/SALIENT CHARACTERISTICS

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

5.1.1 One (1) Brand Name or Equal Diagenode Bioruptor Plus:

1. Footprint: in order to fit into the space occupied by the previous instrument, the sonicator shall be a tabletop model and shall not exceed 35 cm x 35 cm x 50 cm (W x D x H).

2. Soundproof box: the sonicator shall operate within a metallic soundproof box (included in purchase), in order to minimize the exposure of lab staff to damaging ultrasonic noise.

The soundproof box shall be able to absorb at least 30 dBA of sound generated by the sonicator.

3. Flexibility in sample volume: the sonicator shall be able to process samples in 1.5 ml and

15 ml tubes, thereby allowing flexibility in sample volumes (from 100 ul up to 2 ml).

4. Throughput: the sonicator shall be able to process a minimum of 6 samples (in 1.5 ml or 15 ml tubes) at the same time, to allow for increased efficiency.

5. Closed environment: the sonicator shall process samples in closed tubes, and not require direct contact of any part of the sonicator with the sample. This will prevent cross-contamination between samples, non-sterility, and introduction of titanium particles to samples (which can be shed from probe sonicator tips). All of these elements are crucial for using sonicated samples in down-stream animal experiments.

6. Continuous sample rotation: the sonicator shall continuously rotate sample tubes through the ultrasound field so each sample is exposed to the same intensity of energy.

7. Sonication bath-based rotor: the sonicator rotor shall be designed such that ultrasound waves are randomly reflected off of the bath walls, therefore allowing dissipation of heat and providing uniform absorption of energy.

8. Adaptive cavitation technology: the sonicator shall use a highly-controlled ultrasonic energy with adaptive cavitation technology to achieve random and unbiased shearing for different fragment lengths from 150 bp to 1 kb. This will preserve the integrity of biological samples and ensure high sample recovery.

9. Isothermal technology: the sonicator shall have a cooling system that provides isothermal processing to preserve the integrity of biological samples, with an external valve that guarantees the automatic temperature control of the bath during the full shearing process.

10. Ease of use: the sonicator shall have a simple design with minimum control of different parameters.

11. Effective lipid vesicle preparation: the sonicator shall have high-throughput capability and reproducibility when preparing lipid vesicles (which are essential for our research).

Having closed tubes will eliminate the need for direct contact, preventing sample contamination. Precise temperature control will preserve the lipids from damage through overheating or oxidation. Sonication time required to form lipid vesicles should be no more than 20 minutes, with a minimal amount of large lipid aggregates remaining after this amount of time.

5.2 TRADE-IN

The Contractor shall accept trade-in of one existing system as part of this requirement. The trade-in includes one (1) Diagenode Bioruptor Sonicator model UCD200TM (Serial Number 302848).

The Contractor shall provide all applicable services for removal of the existing system such as labor, equipment, packaging/crates, shipping, and insurance. Removal of equipment from laboratory spaces must be coordinated with the TPOC to minimize impact on laboratory operations.

5.3 WARRANTY

In addition to the Implied warranty contained in FAR Clause 52.212-4, quoters are encouraged to provide express warranties. At a minimum, the Contractor shall provide a 12-month warranty or longer from date of final installation on all equipment and associated items provided under, or as a part of this purchase order. The warranty shall include repair and or replacement of parts, including travel, labor, and materials, at no additional cost to the Government. The warranty shall not exclude or limit the Governments rights for an Implied warranty as established in the terms and conditions of clause 52.212-4.

5.4 DELIVERY / INSTALLATION

Delivery of all items quoted shall be within sixty (60) calendar days after receipt of order. All shipping/handling shall be FOB Destination, and delivery/installation fees shall be included in the quote. Upon delivery, the Contractor shall notify the respective NCI Technical Point of Contact (TPOC), TBD at award, to schedule installation dates and times. Installation shall occur within sixty (60) calendar days of delivery, and shall be performed by, or under the direct super vision of, an Original Equipment Manufacturer (OEM) certified technician. Equipment shall be delivered to and installed at the following address:

Item Description Delivery Address Date 1 One (1) Tabletop Bath

Sonicator NIH/NCI/ Laboratory of Molecular Biology Building 37, Room 5110 37 Convent Drive Bethesda, MD 20892

60 Days After Award

6.0 INSPECTION AND ACCEPTANCE

Pursuant to FAR Clause 52.212-4, all items, services, materials, or supplies to be provided by the Contractor in relation to this Purchase Order are subject to final inspection and acceptance by an authorized representative of the Government. The authorized representative of the Government is the Technical Point of Contact (TPOC).

7.0 TECHNICAL POINT OF CONTACT

The Technical Point of Contact (TPOC) is responsible for inspection and acceptance of all work in relation to this requirement and will serve as the Governments primary point of contact throughout the duration of the requirement. All efforts must be coordinated with this individual.

The TPOC for this requirement is:

TBD (upon award)

Note: The TPOC has limited authority as defined within this Statement of Need. They do not have the authority to commit or obligate Government funds or make changes to the terms and conditions of the purchase order. As such, any changes to the purchase order must be performed by a warranted Government Contracting Officer with appropriate delegated authority to do so.