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GENERAL INFORMATION/CLASSIFICATION

Title: Brand Name Wilson Wolf Cell Culture Products for Adoptive Cell

Therapy Notice Type: Combined Synopsis / Solicitation Solicitation Number: 75N91024-CSS-6900011 Posted Date: 06/17/2024 Response Date: 06/21/2024 PSC Code: 6640 – Laboratory Equipment and Supplies NAICS Code: 334516 – Analytical Laboratory Instrument Manufacturing

ISSUED BY:

National Institutes of Health (NIH), National Cancer Institute (NCI), Office of Acquisitions (OA)

This is a Combined Synopsis/Solicitation for commercial items, prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, as supplemented with additional information included in this notice, and shall be processed in accordance with (FAR Part 13– Simplified Acquisition Procedures / FAR 13.5 - Simplified Procedures for Certain Commercial Products and Commercial Services). This announcement constitutes the only solicitation that will be provided in relation to the stated need contained herein. This solicitation is issued as a Request for Quote (RFQ) and includes applicable provisions and clauses in effect through FAR Federal Acquisition Circular (FAC) 2024-02 (12/22/2023).

The requirement’s suggested North American Industry Classification System (NAICS) code is 334516 – Analytical Laboratory Instrument Manufacturing with a size standard of 1000 Employees.

One Firm-Fixed-Priced award is anticipated to be made as a result of this solicitation.

***PLEASE REVIEW THE ATTACHED DOCUMENTS***

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QUOTE SUBMISSION / EVALUATION (52.212-1 ADDENDA)

GENERAL INSTRUCTIONS

This Request for Quotation (RFQ) does not commit the Government to pay any cost for the preparation and submission of a quote. In addition, the Contracting Officer is the only individual who can legally commit the Government to the expenditure of public funds in connection with this proposed acquisition.

By submitting a quote in response to this solicitation, it is understood that your firm’s quote shall become a part of the official contract file. The Government is not responsible for locating or securing any information which the Quoter does not include or identify in their quotation.

QUESTION SUBMISSIONS

Please submit questions concerning this RFQ via email by no later than 3:00 P.M. EST on June 19, 2024 (06/19/2024) to the point of contact listed below:

Name: Miguel Diaz Contracting Officer Email: miguel.diaz@nih.gov

Note: Questions submitted by a method other than email will not be accepted. Any questions received after the specified cut-off time and date above will not be accepted or answered unless at the Contracting Officers discretion is deemed necessary. Additionally, all questions and answers of common interest will be provided to all prospective offerors via an amendment to the posting. All emails must include the Solicitation number “75N91024-CSS-6900011” in the subject line.

QUOTATION SUBMISSIONS (Note: Recommended Quote Submission template shown in Section

2.0 – BRAND NAME PRODUCTS on Page 5 of 6.)

Quotations submitted in response to this solicitation must be submitted via email no later than 3:00 P.M.

EST on June 21, 2024 (06/21/2024) to the point of contract listed below:

Name: Miguel Diaz Contracting Officer Email: miguel.diaz@nih.gov

Quoters may submit more than one quote. If multiple quotes are provided, the Government will evaluate each quote separately. All quotations shall provide enough information for the Government to conduct a thorough evaluation of the quotes provided, and the quoter’s ability to fulfill the stated needs within this RFQ. All quoters must be registered in SAM.gov and be eligible for all awards (FAR 52.204-7 System for Awrad Management). Quoters that do not have an active SAM.gov registration with an eligibility for all awards will not be considered for award. At a minimum, all quotes shall include in the following:

1. Company Name

2. Point of Contact (POC) (including telephone and email address) for individuals authorized to commit on behalf of their organization. Including name, address, and telephone number of the offeror.

3. Company’s System for Award Management Unique Entity Identifier (UEI)

4. Socio-economic status (8(a), SDVOSB, VOSB, Woman-Owned, Other… etc.).

5. Provide product information such as brochures, manuals, etc. to demonstrate that the proposed equipment is:

mailto:miguel.diaz@nih.gov mailto:miguel.diaz@nih.gov

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a. equal to or greater than the minimum required features/characteristics listed in Section 1.0

SPECIAL ORDER REQUIREMENTS.

b. the brand name equipment listed in Section 2.0 BRAND NAME PRODUCTS.

6. Provide any available pricing information including all discount terms. Include a statement to the effect that pricing is firm for a period of at least 60 days from the date of receipt thereof by the Government.

7. Provide the proposed products’ Country of Origin and any available information demonstrating the Country of Origin.

8. Terms of any Express Warranty.

9. Provide information pertaining to the origin of the equipment, and where it’s manufactured.

10. A completed copy of the representations and certifications at Federal Acquisition Regulation

(FAR) 52.212-3 (see FAR 52.212-3(b)) for those representations and certifications that the offeror shall complete electronically) (See attachment to the Combined Synopsis Solicitation).

11. A technical description of the items/services being offered in sufficient detail to evaluate compliance with the requirements in the solicitation. This may include product literature, or other documents, if necessary.

Note: It’s the Quoter’s responsibility to read the RFQ and all related documents carefully. Additionally, it is the Quoter’s responsibility to ensure/verify the Government receives its submission on or before the date/time specified above. The Government reserves the right to not accept any late quotes, any quote that does not provide items/services requested, or quotes that do not conform to the requirements of the RFQ. Please do not wait until the deadline to submit your quotation. Quotes submitted by any other means other than email will not be accepted. All emails must include the Solicitation number “75N91024-CSS-6826350” in the subject line.

BASIS FOR AWARD AND EVALUATION

An award shall be made to the firm that submits the Lowest Price Technically Acceptable (LPTA) quote that is technically acceptable in accordance with the required need outlined in the Statement of Need (SON). A technically acceptable quote is one in which the quoter(s) complies with the requirements in the (SON) and does not take exception, nor object to the terms of the RFQ. Quotes that are not technically acceptable will not be considered for award. The award will be made on an all or none basis.

The Government reserves the right to assess the lowest priced quote only. If the lowest priced quote is found to be technically unacceptable, the Government will then assess the second lowest priced quote and continue this process until an award can be made.

The Government intends to evaluate quotations and make an award without conducting “discussions.”

Quotes which merely offer to conduct services in accordance with the requirements of the Government's scope of work will not be eligible for an award. Therefore, the Quoter’s initial quote should contain the best terms from a price and technical standpoint. The Government reserves the right to request revisions that seek additional price discounts, revisions to the technical quote, or clarifications for aspects of the quote. If the Government seeks revisions or clarifications, the Government will provide a reasonable deadline for submission of those revisions/clarifications based on the complexity of the request. The Government reserves the right to request revisions or clarifications from only one or a select number of Quoters, if doing so would be in the public’s interest. The Government may reject any or all quotes if such action is in the public interest; accept other than the lowest quote; and waive informalities and minor irregularities in quotes received.

Prior to award the Government will require written concurrence from the contractor prior to issuance of an executed award.

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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 the 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 capability. 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 synopsis and solicitation may be published. However, responses to this notice will not be considered an adequate response to a solicitation(s).

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1.0 TITLE

Brand Name Wilson Wolf Cell Culture Products for Adoptive Cell Therapy

2.0 BACKGROUND

The Cell Production Facility of the Surgery Branch (SB) at the Center for Cancer Research (CCR), National Cancer Institute (NCI), National Institutes of Health (NIH), manufactures immune cells to support a series of adoptive cell transfer therapies for NCI cancer patients. For adoptive transfer protocols only equipment and reagents that are produced in accordance with good manufacturing practices (GMP) and approved by the Food and Drug Administration (FDA) for specific protocols can be utilized to expand patient cells, as mandated by the FDA. Currently, all NCI Surgery Branch FDA-approved Investigational New Drug (IND) protocols for cell transfer therapies mandate the use of single-use Wilson Wolf stand-alone bioreactor cell culture products. These products support the rapid expansion of patients’ cells under static conditions in as small a volume of media as possible to facilitate harvesting and washing of the cells.

The bioreactors from Wilson Wolf are critical for the SB to successfully expand patient cells to high densities under static conditions. Static culture conditions are crucial for the early stages of lymphocyte expansion to provide the critical costimulatory signals to initiate a successful patient treatment. Wilson Wolf bioreactors are specifically designed and optimized for the expansion of human immune cells through the implementation of proprietary G-REX (gas permeable rapid expansion) cell culture technology. They have been used successfully by SB since more than thirteen years to grow high-quality patient cells for adoptive cell therapy with the required cell phenotype at high expansion rates, and SB’s cellular therapy manufacturing protocols have been optimized for the use of these bioreactors. Each treatment requires a minimum of thirty (30) bioreactors, with more than one patient treatment being scheduled at a given time.

2.1 BRAND NAME

The Surgery Branch (SB) at the National Cancer Institute has an ongoing clinical program using adoptive cell transfer therapy for the treatment of patients with metastatic cancer. The cell production laboratory of the SB uses a number of techniques to identify, purify and expand tumor reactive T lymphocytes from patients with advanced cancer. For adoptive transfer protocols only equipment and reagents that are produced in accordance with good manufacturing practices (GMP) can be utilized to expand patient cells, as mandated by the FDA. The NCI Surgery Branch uses Wilson Wolf cell culture products to grow sufficient quantities of T-cell receptor transduced T-cells to treat NCI cancer patients. The NIH protocols to use these products are approved by the Institutional Review Board (IRB) and, in the case of INDs (Investigational New Drugs), have been approved by the U.S. Food and Drug Administration for treatment of human subjects. No substitutions are permitted. The need for cellular manufacturing is entirely driven by patient eligibility and the supplies must be delivered without delays to ensure the clinical schedule for patient treatments can be met as committed. Additionally, the Surgery Branch requires a certificate of analysis (COA) for every lot procured for use under the approved FDA INDs.

T-cell receptor transduced T-cells cannot be grown to achieve therapeutic use by conventional cell culture methods. Wilson Wolf cell culture products incorporate propriety G-REX (gas permeable rapid expansion) cell culture technology. This propriety technology maintains cell

75N91024 -CSS-6900011 Page 6 of 8 populations under conditions which are optimized to retain their original phenotype. The technology also supports short cell production cycles for rapid cell expansion. Furthermore, Wilson Wolf cell culture products are specifically designed for the expansion of immune cells, minimize the requirement for feeder cells, and reduce feeding requirements during cell expansion. No other known product can support T lymphocyte rapid expansions from initiation to conclusion in dense static culture conditions. Therefore, Wilson Wolf products are the only known cell culture products on the market which fulfill the need of the NCI.

2.2 OBJECTIVE

The clinical schedule for cellular manufacturing at SB’s Cell Production Facility is driven by patient eligibility and schedule. With this purchase order, the Cell Production Facility aims to establish a system that supports the regular delivery of two types of Wilson Wolf bioreactors in any combination and quantity, to manufacture cells without delay as soon as patients become eligible.

3.0 TYPE OF ORDER

This shall be a firm fixed price purchase order.

4.0 SPECIAL ORDER REQUIREMENTS

This acquisition entails the scheduled delivery of a set amount of Wilson Wolf bioreactor products to the NCI Surgery Branch Cell Production Facility every four (4) weeks. The Contractor shall deliver the products without delays to ensure the clinical schedule for patient treatments can be met as committed.

4.1 PRODUCT FEATURES/SALIENT CHARACTERISTICS

The following product features/characteristics are required for the stand-alone bioreactor cell culture products:

1. Must be manufactured by Wilson Wolf Manufacturing Corporation.

2. Shall consist of a gas permeable membrane, a vessel, and a cap which is equipped with a hydrophobic filter membrane (0.2 μm).

3. Must be specifically designed for the expansion and recovery of immune cells.

4. Must maintain cell populations under conditions which are optimized to retain their original phenotype; demonstrated through consistent ratios of CD4 (cluster of differentiation 4) to CD8 cells.

5. Must eliminate the need for feeder cells and for feeding during cell expansion.

6. Must support short cell production cycles/rapid cell expansion.

7. Must have the capability of performing without the use of specialized equipment (e.g., rockers).

8. Shall be an open system with a growth area of 100 cm2.

9. Shall be available in two sizes, with 450 – 500 ml media capacity, and with 1,000 – 1,100 ml media capacity.

10. Shall not exceed 14 cm in diameter.

11. Shall not include any latex, BPA, phthalates, nitrosamines, residual solvents or mold release agents in their component manufacturing or final device assembly.

12. Must be sterile and produced in accordance with good manufacturing practices (GMP).

13. Each lot must include a Certificate of Analysis.

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14. Storage conditions shall be ambient (room temperature, no humidity controls required).

5.0 BRAND NAME PRODUCTS.

5.1 The following Brand Name products have been identified to fulfill these requirements:

Item Product Description Product No. Qty Amount

Wilson Wolf G-Rex100 (3-pack box), 450 mL media capacity

80500 416

Wilson Wolf G-Rex100M (3-pack box), 1,000 mL media capacity

81100 13

3 Shipping n/a 1 Total:

5.2 DELIVERY

The Contractor must have the capability and capacity of delivering the products without delay in the quantities required throughout the entire period of performance; to ensure patients can undergo cell transfer therapy in accordance with their treatment schedule without encountering dangerous, potentially life-threatening interruptions.

Every four (4) weeks, the Contractor shall make a scheduled delivery of a product amount and combination agreed upon with the TPOC. The order will typically consist of a quantity of 32 boxes from one or a combination of two catalog numbers (see table below). A total of 416 boxes, delivered in 13 individual shipments, is anticipated.

The TPOC will place the order for shipment no later than two (2) weeks prior to shipping by email to the Contractor. The Contractor shall confirm the scheduled order with the TPOC two (2) weeks prior to the scheduled delivery date, provide a shipping tracking number to the TPOC, and immediately contact the carrier when the delivery is unexpectedly rescheduled or fails.

The Contractor must provide a Certificate of Analysis (COA) within two (2) business days of receiving the order for every product lot delivered.

Each delivered item shall be from a recent production lot to ensure maximum shelf-life, with an expiration date of at least nine (9) months from the date of delivery.

All items shall be shipped under conditions as specified by the original manufacturer to ensure product integrity. The Contractor shall replace supplies found to be damaged or defective or for incorrect or incomplete shipments at no additional cost to the Government.

The Contractor shall contact the TPOC and the Contracting Officer in the event an upgraded product by the original manufacturer becomes available during the period of performance. The Government will decide if the Contractor shall substitute the product to the most recent version.

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The shipments shall be delivered to the following address:

Clinical Research Center (CRC) NCI Surgery Branch, Cell Production Facility Building T30 Room 100 30 Convent Drive Bethesda, MD 20892

6.0 INSPECTION AND ACCEPTANCE

Pursuant to FAR Clause 52.212-4, all items to be delivered in relation to this award 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) who is responsible for inspection and acceptance of all services, materials, or supplies to be provided by the Contractor. The NCI Technical Point of Contact (TPOC) will be listed in the purchase order.

7.0 PERIOD OF PERFORMANCE

The period of performance shall be for twelve (12) months. The Government will place the first order for shipment within four weeks of the award.

7.1 OPTIONS (4) FOR ADDITIONAL QUANTITIES

This order shall contain four (4) Options for Additional Quantities. The Contractor shall make a delivery of 20 boxes in a single shipment with a product combination agreed upon with the TPOC. This order may be any combination of product catalog #80500 and #81100.

8.0 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.

Note: The TPOC has limited authority as defined within this Statement of Work. 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.

9.0 INSPECTION AND ACCEPTANCE

Pursuant to FAR clause 52.212-4, all work described in the SOW to be delivered under this purchase order is subject to final inspection and acceptance by an authorized representative of the Government. The authorized representative of the Government is the NCI Technical Point of Contact (TPOC) who is responsible for inspection and acceptance of all services, materials, or supplies to be provided by the Contractor.

10.0 PAYMENT

Payment shall be made after successful delivery and acceptance by the NCI Technical Point of Contact (TPOC).