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Solicitation Number: 75N95023Q00614

Title: Nanobody Generation from Camelids

i. This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a separate written solicitation will not be issued.

ii. This acquisition is for a commercial item or service and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13—Simplified Acquisition Procedures; and FAR Part 12—Acquisition of Commercial Items and is not expected to exceed the simplified acquisition threshold. A fixed-price type of purchase order is contemplated for this requirement.

The solicitation number is 75N95023Q00614 and the solicitation is issued as a request for quotation (RFQ) as a total small business set-aside.

(iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2023-05 / 09-07-2023.

(iv) The associated NAICS code 541690 – Other Scientific and Technical Consulting Services and the small business size standard $9.0 M. This requirement is a total small business set-aside.

(v) National Institute of Neurological Disorder and Stroke (NINDS), Molecular Physiology and Biophysics Section (MPBS) requires the services of a contractor to obtain camelid animal husbandry, injection, and peripheral blood mononuclear cell (PBMC) / ribonucleic acid (RNA) harvesting service for nanobody generation.

(vi) STATEMENT OF WORK (SERVICES) (SOW)

Background Information and Objective: Nanobody is a single-domain antibody that are found only in a few species of animal such as the camelids (alpaca, llama, camels for example). Like whole antibodies, nanobody is capable of binding selectively to a specific antigen and sometimes with even more robust affinity. Due to their smaller size, they are easier to isolate, and mass produced in bulk.

The NINDS MPBS Laboratory require nanobodies generated against two-ion channel proteins of interest. These nanobodies would be used for stabilizing the proteins for structural studies. MPBS would also test if some of the nanobodies could affect the functions of these proteins using functional studies and in the long term to pull down complexes from native tissues to study protein-protein interactions.

Commercially available antibodies against these two-ion channel proteins have been purchased and tested. As seen from all literature searched and data reported so far, none of the commercially available antibodies show robust or good enough binding capacity to our two proteins of interest.

Therefore, MPBS will attempt to generate nanobodies from camelids which have been widely reported in literature as having more robust affinity.

The vendor/contractor with a USDA and NIH approved camelid farm (with assurance numbers provided) that can immunize the animal (one alpaca and one llama) for nanobody generation is required for this project.

All veterinary care, injections and husbandry and blood collection will be performed by the vendor/contractor. MPBS will be provided with the pre- and post-immunized serum. From the final serum, the vendor/contractor will perform the RNA extraction from PBMCs (peripheral blood mononuclear cells). After such time, MPBS will be provided with RNA to generate cDNA from the RNA samples for constructing a phage display library and searching for nanobodies that have robust binding to the two ion channel proteins of interest.

General Requirements: Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work below:

Specific Requirements: The vendor/contractor shall provide all husbandry, animal housing, veterinary care, blood/serum collection, PBMC isolation and RNA isolation from one alpaca and one llama for the purpose of nanobody generation. This includes 5 immunizations, 1 pre-immune bleed (~10ml serum), 1 test bleed (~10ml serum), 2 production bleeds (500ml whole blood), total IgG serum titer ELISA testing of all bleeds, IgG 2_3 serum titer ELISA testing of final bleed. For PBMC isolation, 2 production bleeds (> 1x107 cells/each production bleeds) are required and then preservation of PBMC cells for RNA purification.

GOVERNMENT RESPONSIBILITIES: Government will provide initial purified protein samples for immunization into one alpaca and one llama. No other samples or reagent shall be required or submitted by the government.

DELIVERY OR DELIVERABLES: Government should receive all blood/serum collected and PBMC and RNA purified at the end of the project.

REPORTING REQUIREMENTS: Vendor/contractor is not required to report to government with any written progress unless animal health is affected. In the event that an animal becomes ill/sick due to immunization, vendor should notify government in writing and adhere to all USDA and NIH specified governing laws for animal handling and veterinary care.

(vii) The period of performance is four (4) to six (6) months. September 2023 through March 2024. Delivery shall be made Thirty (30) to sixty (60) calendar days after receipt of the order. Delivery shall be made to the National Institute of Neurological Disorder and Stroke (NINDS), Molecular Physiology and Biophysics Section (MPBS).

(viii) The provision at FAR Clause 52.212-1 Instructions to Offerors—Commercial Items (September 2023), is applicable to this solicitation.

(ix) The provision at FAR Clause 52.212-2, Evaluation-Commercial Items (November 2021), applies to this acquisition.

(a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The total points possible is 100. The following factors shall be used to evaluate offers: (1) Technical Capability: Points Possible: fifty (50); Narrative: The offeror shall detail in a technical proposal the processes and methods it will use for completion of the project requirements as well as the qualifications of the contractor employees to perform this work; (2) Timeliness and Delivery: Points Possible: Twenty-Five (25); Narrative: The offeror shall detail in a technical proposal how it shall meet the delivery timeframe and method requirements. The Government shall evaluate the offeror’s ability to meet or exceed the requirements detailed in this statement of work; (3) Past Performance: Points Possible: Twenty-Five (25); Narrative: The offeror must have prior experience in the manufacture of Nanobody Generation from Camelids; and (4) Cost/Price: Cost not a rated factor.

Although technical factors are of paramount consideration in the award of the contract, price and past performance are also important to the overall contract award decision. All evaluation factors other than price, when combined, are significantly more important than price. The Government intends to make an award to that offeror whose proposal provides the best overall value to the Government.

The evaluation will be based on the demonstrated capabilities of the prospective Contractors in relation to the needs of the project as set forth in herein. The merits of each proposal will be evaluated carefully. Each proposal must document the feasibility of successful implementation of the requirement as set forth herein. Offerors must submit information sufficient to evaluate their proposals based on the detailed factors set forth above.

The evaluation factors are used when reviewing the proposals: (1) Technical Capability and Functionality—NIDA shall evaluate the offeror’s technical approach for overall capability and functionality in relation to the General Requirement, Salient Characteristics, Quantity and Deliverables as described in the Purchase Description; (2) Contract Management and Customer Support—NIDA shall evaluate the offeror’s ability to provide a high level of customer service, particularly in the area of initial responsiveness and resolution of device and service problems; (3) Speed of Delivery, Installation and Set-up—NIDA shall evaluate the offeror’s technical approach for completeness, feasibility, soundness and practicality of the proposed approach and work plan for accomplishing the requirements of the statement of work; (4) Past Performance—Offerors will be evaluated based on information obtained from references provided by the offeror, other relevant past performance information obtained from other sources known to the Government, and any information supplied by the offeror concerning problems encountered on the identified contracts and corrective action taken. Furthermore, the Government will assess the relative risks associated with each offeror. Performance risks are those associated with an offeror's likelihood of success in performing the acquisition requirements as indicated by that offeror's record of past performance. The assessment of performance risk is not intended to be the product of a mechanical or mathematical analysis of an offeror's performance on a list of contracts but rather the product of subjective judgment by the Government after it considers all available and relevant information; and (5) Price— Offerors price quote will be evaluated for reasonableness. For a price to be reasonable, it must represent a price to the government that a prudent person would pay when consideration is given to prices in the market. Normally, price reasonableness is established through adequate price competition, but may also be determined through cost and price analysis techniques. Price evaluation will not be conducted on any Offeror determined to be technically unacceptable.

Offerors may respond with a proposal indicating their ability to provide the technical specifications stated in this solicitation. Responses will be evaluated based on the contractor’s ability to meet the Government’s requirements.

(b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s).

(c) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer’s specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award. (End of provision)

x. The provision at FAR Clause 52.212-3, Offeror Representations and Certifications Commercial Items (September 2023), applies to this acquisition.

xi. The provision at FAR Clause 52.212-4, Contract Terms and Conditions—Commercial Items (December 2022), applies to this acquisition.

xii. The provision of FAR Clause 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders Commercial Items (September 2023), applies to this acquisition.

xiii. There are no additional contract requirement(s) or terms and conditions applicable to this acquisition.

xiv. The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement.

xv. Responses to this solicitation must include sufficient information to establish the interested parties’ bona-fide capabilities of providing the product or service. Responses to this solicitation must include clear and convincing evidence of the Offeror’s capability of fulfilling the requirement as it relates to the government requirements stated in this solicitation.

Basic cost and price information in the Offeror’s proposal must contain sufficient information to allow the Government to perform a basic analysis of the reasonableness of the Offeror to supply the required goods/services. Any other information or factors that may be considered in the award decision may include such factors as: past performance; special features required for effective service coverage; trade-in considerations; warranty considerations; maintenance and service coverage availability; serial, product or catalog number(s); product description; delivery terms, and prompt payment discount terms.

Offerors must submit its quote electronically.

Offerors MUST include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications Commercial Items, with their offer, OR provide a copy of the valid certifications registrations and Representation and Certifications from the System of Award Management (SAM) applications at www.SAM.gov, which may be indicated on the Offeror’s cover sheet.

In addition, the offeror’s Unique Entity Identifier (UEI) and the certification of business size must be included in the response. All Offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.”

All responses must be received no later than September 20, 2023, 12:00 Noon, Eastern Standard Time. Late responses will not be accepted. All responses must reference solicitation number 75N95023Q00614. Responses must be submitted electronically to debra.hawkins@nih.gov. For information regarding this solicitation, please contact Debra C. Hawkins by email at debra.hawkins@nih.gov or by phone at 301-827-7751.

xvi. DATE QUESTIONS DUE: Questions and requests for clarification must be submitted electronically to Debra C. Hawkins, at debra.hawkins@nih.gov on or before September 18, 2023. 12:00 Noon, Eastern Standard Time, Fax responses will NOT be accepted.

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