Adeno-associated Virus (AAV) preps

This is a Small Business Sources Sought (SBSS) notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their 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. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice.
This notice is issued to help determine the availability and type of qualified Small Business companies technically capable of meeting this potential 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. The notice is strictly for research and information purposes only.

The information requested will assist the Government in determining the appropriate acquisition method including small business socio-economic set-aside possibilities and to determine the availability of qualified Small Business companies technically capable of meeting the Government's potential requirement. All Small Business companies with the capability and availability to perform the requirement under the applicable NAICS code are invited to submit a response to this notice.

NORTH AMERICAN CLASSIFICATION SYSTEM (NAICS) CODE
The NAICS code applicable to this requirement is 325414-Biological Product (except
Diagnostic) Manufacturing with size standard 1250 employees.

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. The National Center for Advancing Translational Sciences (NCATS) focuses on getting more treatments to more patients more quickly. Several thousand genetic diseases affect humans, of which only about 500 have any treatment. NCATS is directly addressing this problem by discovering new technologies and other approaches that could greatly accelerate the process of developing and deploying solutions that can be used by all translational researchers.

The Cures Acceleration Network (CAN) was established within the Division of Preclinical Innovation (DPI), Therapeutics Development Branch (TDB) at NCATS to advance the development of high-need cures and reduce significant barriers between research discovery and clinical trials. The CAN funds a variety of initiatives designed to address scientific and technical challenges that slow down transitional research and currently is supporting projects through the Tissue Chip for Drug Screening, Biomedical Data Translator and 3-D Tissue Bioprinting programs at NCATS.

NCATS CAN is supporting a basket trial gene therapy project for heredity disorders of vitamin B12 (cobalamin) and methylmalonic acid metabolism. The objective of this potential requirement is to acquire adeno-associated virus (AAV) Serotypes Type 9 viral preps expressing human codon optimized mMut and MMAB donor sequences. The above-mentioned items are non-pathogenic viruses that will be used in gene therapy experiments in proprietary mouse models methylmalonic acidemia (MMA) and cblB (MMAB) deficiency. These viral preps will be used to test gene therapy strategies in disease model mice that have been genetically engineered to be missing the enzyme/protein the viruses will carry, specifically the mMut and MMAB gene. This potential requirement will support the Platform Vector Gene Therapy project at NCATS.

Purpose and Objectives
The purpose of this potential acquisition is to obtain Adeno-associated Virus (AAV) Serotypes Type 9 preps, quantity 15, expressing human codon optimized mMut and MMAB donor sequences.

Project Requirements
Offerors submitting a response to this Small Business Sources Sought notice shall possess the ability to achieve the essential government features specified herein. Products offered must include those salient physical, functional, or other characteristics of the items identified in this notice that are manufactured by the subject vendor deemed essential in meeting the government's needs.
Specifically, the following are considered essential characteristics of this potential requirement:
• AAV vectors purified by two rounds of CsCl sedimentation to achieve high percentage (>90%) fully packaged particles at high titer (>1.0 x 10^13 GC/mL).
• Vector purity assessed by 4%-12% SDS-acrylamide gel electrophoresis and silver staining.
• Vectors titered by digital droplet PCR

Quantity: Adeno-associated Virus (AAV) Serotypes Type 9 preps expressing human codon optimized mMut and MMAB donor sequence - Qty 15

Period of Performance/Delivery period: The period of performance and order deliveries will be completed within 1 year from effective date of award.

Contractors submitting a response to this Small Business Sources Sought notice shall possess the ability to achieve the salient government essential features of this potential requirement. Specifically, Offerors to this Small Business Sources Sought notice shall document evidence of being able to provide the subject supply that will allow for the essential features described herein to be accomplished.

Delivery/Warranty
Offerors must indicate an estimated delivery time in full after receipt of an order and any training or warranty applicable. A fixed-price type of Purchase Order contract is anticipated to be awarded on or around September 1, 2019. The Government anticipates partial delivery within 2 months of award followed by a staggered delivery schedule to complete the order within 12 months after effective date of contract. Inspection and acceptance will be performed at NCATS located at 9800 Medical Center Drive, Rockville, MD 20852.

CAPABILITY STATEMENTS/INFORMATION SOUGHT
Interested parties are expected to review this notice to familiarize itself with the requirements of this project. Failure to do so will be at your firm's own risk.

Respondents must provide, as part of their response: (a) product, catalog, model, and/or part number(s); (b) product description; (c) all relevant information and documentation that the item(s) offered meets the salient physical, functional, or performance characteristics as specified in this announcement; (d) quantity; (e) shipping, handling, and/or installation instructions, and/or any special delivery conditions after receipt of an order.

Respondents that believe that they are manufacturers or authorized re-sellers of the equipment specified in this announcement must provide, as part of their response: (a) product, catalog, model, and/or part number(s); (b) product description; (c) all relevant information and documentation that the item(s) offered meets the salient physical, functional, or performance characteristics as specified in the purchase description; (d) quantity; (e) estimated price or cost; (f) shipping, handling, and/or installation charges; and delivery date after receipt of order.

The respondent must also provide their DUNS number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HubZone, etc.) pursuant to the applicable NAICS code and any other information that may be helpful in developing or finalizing the acquisition requirements.

The information submitted must be in outline format that addresses each of the elements of this requirement. A cover page and an executive summary may be included but is not required.
The response is limited to ten (10) pages. The 10-page limit does not include the cover page, executive summary, or references, if requested.

The response must include the respondents' technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses.
Respondents must reference the subject announcement number on all correspondence related to this Small Business Sources Sought notice. The response must be submitted to Hunter Tjugum electronically, at hunter.tjugum@nih.gov, and be received prior to the closing date specified in this announcement.

CONCLUDING STATEMENTS
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 pre-solicitation 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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