Microfluidic-based microphysiological systems (MPS) assay platform

SOURCES SOUGHT NOTICE
1. Sources Sought Number: 75N95019Q00195

2. Title: Microfluidic-based microphysiological systems (MPS) assay platform

3. Classification Code: 6640 Laboratory Equipment and Supplies

4. NAICS Code: 334516 Analytical Laboratory Instrument Manufacturing

5. Notice Description:

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.

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.

6. Project Description:

The National Center for Advancing Translational Science (NCATS) of the National Institutes of Health has a requirement for a commercially-available microfluidic-based microphysiological systems (MPS) assay platform to support efficacy and toxicity/PK studies during lead identification and optimization efforts.

7. Purpose and Objectives:

The Division of Pre-Clinical Innovation (DPI) of NCATS has assessed MPS platforms that are currently commercially available according to cost, commercial readiness, medium compound throughput (12 treatment conditions at a time), and technical requirements for being a versatile system to enable flow and stretching assay settings. Such an apparatus will increase the throughput of microfluidic-based microphysiological systems, expand the breadth of advanced cellular assays that can be developed and screened under in vivo relevant mechanical flow and stretching conditions. By using a machine that can be programmed and operated in an incubator without the use of peristaltic pumps, tubing or syringes, it is expected that more precise and reproducible results are to be produced. In addition, walk-away time afforded by automating protocols will allow staff to focus on more complex intellectual pursuits associated with the research.

It has been determined that the MPS technology used in the instruments from Emulate, Inc., are the most appropriate of the MPS technologies commercially available that meet the requirements identified by NCATS scientists (see salient characteristics, below). The instrument is precisely poised to support particularly demanding assay protocols that NCATS scientist need to develop for developing compounds in more predictive assays for drug discovery and development. NCATS seeks to determine whether other sources for such an instrument are commercially available.

Project requirements:

NCATS has identified the following salient characteristics that any assay platform must meet or exceed:

SC-1: The system must use a Silicone Polymer Chip in which channels are separated by a membrane (pore diameter 5-10 um) which allows the chip to be placed under certain mechanical forces which recapitulate the microenvironment of the human body.

SC-2: The chip must be connected to a device that allows the addition of fluid to the epithelial chamber and the endothelial chamber independently without the use of peristaltic pumps, tubing or syringes.

SC-3: Flow and stretch on the system must be user selectable via a digital user interface allowing flow rates selection (between 0ul/hr - 1000ul/hr) and stretch should also be user selectable ( between 0.01Hz to Max 0.4Hz).

SC-4: The instrument in which chip is housed must fit inside an incubator and user shall be able to pre-program to control flow, stretch and enable the treatment of the cells in the epithelial and endothelial independently, and >10 Chips run per instrument.

SC-5: The chip must be of high clarity and optically transparent to allow high content imaging. The system must be designed so that the chip can be removed from the instrument which is housed in the incubator, and live cell imaging can be done on a microscope and the chip and module can be placed back in the system in the incubator.

SC-6: The Chip must be easily removable from the instrument control system that its housed in and there should be 4 reservoirs, 2 for the fluid flowing through the epithelial and endothelial chambers and 2 collection reservoirs so that effluent can be collected at anytime though out the duration of the incubator.

SC7: The instrument that runs the chips must do so via pressure internally removing the need for any pumping system.

Anticipated period of performance: NCATS expects to issue a purchase order in FY19 (no later than September 30, 2019) and require delivery of the instrument within 8-12 weeks after placement of the order.

8. REQUESTED RESPONSE:

The intent of this sources sought notice is to define the procurement strategy (e.g. set-aside, sole source, unrestricted) for a solicitation that NCATS intends to post soon. Interested contractors are requested to respond by (1) identifying how their proposed product meets or exceeds each of the seven salient charactistics listed above, by number; and (2) providing product literature, white papers, or capability statements that demonstrate their bona fide ability to supply such an instrument within the time frame described above.

In addition, please state your business size status and whether you are the manufacturer or authorized distributor of the device you propose.

Please note that NCATS is particularly interested in small business sources. If you are a small business, please state the type of small business (small business; HUBZone; service-disabled, veteran-owned; 8(a); veteran-owned; woman-owned; or small disadvantaged businesses) and your size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible.

Please note that if no responses to this notice are received from either authorized distributors or providers of potentially equivalent items, then this action will be sole-sourced to the provider cited above.

Please provide your DUNS number, organization name, address, point of contact, other information described above, and any other information that may be helpful in developing or finalizing the acquisition requirements.

The information submitted must be must be in an outline format that addresses each of the elements of the project requirement. A cover page and an executive summary may be included but is not required.

The response must include the respondents' technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses.

9. Due Date:

All responses to this notice must reference number 75N95019Q00195 and be submitted by email to Stuart Kern, Contract Specialist, at stuart.kern@nih.gov.

Responses must be received on or before June 21, 2019, at 11:00 a.m. Eastern time.

10. 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 presolicitation synopsis and solicitation may be published in Federal Business Opportunities. 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).

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