Antivirals for neurotropic viruses of pandemic potential

SOURCES SOUGHT NOTICE

1. Solicitation Number: 75N95023Q00433

1. Title:  Antivirals for neurotropic viruses of pandemic potential

1. Classification Code:  6505-DRUGS AND BIOLOGICALS

1. NAICS Code:  325414 – Biological Product (Except Diagnostic) Manufacturing

1. Size Standard: 1,250 employees

1. Description:  Antivirals for neurotropic viruses of pandemic potential

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, to determine the method of acquisition, and availability of domestic sources manufactured in the United States in sufficient and reasonably available commercial quantities and of a satisfactory quality.  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. Small businesses are encouraged to respond.

For equipment/supply requirements, responses must include the place of manufacturing (i.e. address if supply/equipment is a domestic end product and include country of manufacture). For equipment/supply requirements, small businesses must also address the size status of the manufacturer under the applicable NAICS code (i.e. address Non-Manufacturer Rule).

Background:  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.

The National Center for Advancing Translational Sciences (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.

NCATS requires the components listed below as part of a specialized custom media formulation used to support functional neuronal firing in NCATS 3DTBL designer brain region specific spheroids for high throughput screening and disease modeling.

                                                                        Quantity          Unit                 

BrainPhys Neuronal Medium                         60.00               bottle               

N2 Supplement-B (100X)                               30.00               bottle               

NeuroCult SM1 Neuronal Supplement           20.00               bottle              

N2 Supplement-A (100X), 5mL                      20.00               bottle               

Hu Recom BDNF, ACF, 10ug                        15.00               bottle               

Hu Recom GDNF, ACF, 10ug                        15.00               bottle              

Dibutyryl-cAMP, 500 mg                                 15.00               bottle  

Purpose and Objectives: The purpose of this procurement is acquisition of

                                                                        Quantity          Unit                 

BrainPhys Neuronal Medium                         60.00               bottle               

N2 Supplement-B (100X)                               30.00               bottle               

NeuroCult SM1 Neuronal Supplement           20.00               bottle              

N2 Supplement-A (100X), 5mL                      20.00               bottle               

Hu Recom BDNF, ACF, 10ug                        15.00               bottle               

Hu Recom GDNF, ACF, 10ug                        15.00               bottle              

Dibutyryl-cAMP, 500 mg                                 15.00               bottle  

Project requirements:

60 bottle       BrainPhys Neuronal Medium 

30 bottle       N2 Supplement-B (100X), 5mL 

20 bottle       NeuroCult SM1 Neuronal Supplement 

20 bottle       N2 Supplement-A (100X), 5mL 

15 bottle       Hu Recom BDNF, ACF, 10 ug 

15 bottle       Hu Recom GDNF, ACF, 10ug 

15 bottle       Dibutyryl-cAMP, 500 mg 

Salient characteristics:

1. Must support neuronal culture in monolayer culture and in neuronal spheroid culture for at least 4 weeks.
2. Must support neuronal culture in spheroids with media changes every M,W,F.
3. Must be stable for at least 1 week post combination of all components into complete media.
4. Must support synchronized active neuronal firing as measurable by calcium dyes
5. Base media must be defined and serum-free
6. Components and media must support neurological function and activity
7. Media and components must support long-term culture of iPSC derived neurons and astrocytes
8. BDNF and GDNF must be >95% pure, as well as human in origin and animal component free
9. Dibutyryl-cAMP must be >95% pure and stable for at least 12 months after receipt
10. Must reproducibly support survival and maturation of functional neurons
11. Must be stable at indicated temperatures

Quantity:

                                                                        Quantity          Unit                 

BrainPhys Neuronal Medium                         60.00               bottle               

N2 Supplement-B (100X)                               30.00               bottle               

NeuroCult SM1 Neuronal Supplement           20.00               bottle              

N2 Supplement-A (100X), 5mL                      20.00               bottle               

Hu Recom BDNF, ACF, 10ug                        15.00               bottle               

Hu Recom GDNF, ACF, 10ug                        15.00               bottle              

Dibutyryl-cAMP, 500 mg                                 15.00               bottle  

Anticipated period of performance: 30 days after receipt of order

Other important considerations: Cite any other information that is necessary for potential respondents to understand the nature of the potential requirement or proposed acquisition.

In case domestic sources are available and capable of fulfilling the Government’s need, and a future solicitation is published, the Government will use evaluation preferences in accordance with FAR 25.

Capability statement /information sought.

Companies that believe they possess the capabilities to provide the required products or services should submit documentation of their ability to meet each of the project requirements to the Contracting Officer. The capability statement must specifically address each of the project requirements separately.  Additionally, the capability statement should include 1) the total number of employees, 2) the professional qualifications of personnel as it relates to the requirements outlined, 3) any contractor GSA Schedule contracts and/or other government-wide acquisition contracts (GWACs) by which all of the requirements may be met, if applicable, and 4) any other information considered relevant to this program. Capability statements must also include the Company Name, Unique Entity ID from SAM.gov, Physical Address, and Point of Contact Information. The response must include the respondents’ technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses.

Interested companies are required to identify their type of business, applicable North American Industry Classification System (NAICS) Code, and size standards in accordance with the Small Business Administration. The government requests that no proprietary or confidential business data be submitted in a response to this notice. However, responses that indicate the information therein is proprietary will be properly safeguarded for Government use only. Capability statements must include the name and telephone number of a point of contact having authority and knowledge to discuss responses with Government representatives. Capability statements in response to this market survey that do not provide sufficient information for evaluation will be considered non-responsive. When submitting this information, please reference the solicitation notice number.

One (1) copy of the response is required and must be in Microsoft Word or Adobe PDF format using 11-point or 12-point font, 8-1/2” x 11” paper size, with 1” top, bottom, left and right margins, and with single or double spacing.

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

The response is limited to ten (10) page limit.  The 10-page limit does not include the cover page, executive summary, or references, if requested.

All responses to this notice must be submitted electronically to the Contract Specialist and Contracting Officer.  Facsimile responses are NOT accepted.

The response must be submitted to Maggie Brant at e-mail address maggie.brant@nih.gov.

The response must be received on or beforeJuly 7, 2023, 5:00 pm, Eastern Time.

“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 www.sam.gov. 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).”