SSN BN 75N91024SS6900011.pdf

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GENERAL INFORMATION/CLASSIFICATION

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

Therapy Notice Type: Sources Sought Solicitation Number: 75N91024SS6900011 Posted Date: 04/04/2024 Response Date: 04/11/2024 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)

DESCRIPTION:

This is a Sources Sought Notice (SSN) and is for information and planning purposes only. This notice shall not be construed as a solicitation or as an obligation on the part of the National Cancer Institute (NCI). The purpose of this SSN is to identify qualified business concerns, especially small businesses, that are interested in and capable of performing the work described herein, The NCI does not intend to award a contract based on responses received nor otherwise pay for the preparation of any information submitted. Responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. The requirement’s suggested North American Industry Classification System (NAICS) code is 334516 – Analytical Laboratory Instrument Manufacturing with a size standard of 1000 Employees.

THERE IS NO SOLICITATION AVAILABLE AT THIS TIME. However, should such a requirement materialize, no basis for claims against NCI shall arise because of a response to this SSN or the NCI’s use of such information furnished in response to this notice.

RESPONSE INSTRUCTIONS:

Responses to this notice shall be submitted via email to the Contracting Officer, Miguel Diaz, at miguel.diaz@nih.gov no later than 12:00 P.M. EST on Thursday, April 11, 2024 (04/11/2024). All information furnished must be in writing and must contain enough detail to allow the NCI to determine the respondents’ ability to meet the requirements described herein. A response should not exceed 10 single-sided pages including all attachments, charts, etc. (single space, 12-point font minimum) that clearly responds to the below questions. All proprietary information should be marked as such. Please reference notice number 75N91024SS6900011 for all correspondence.

Requested Information: Please provide the following information in your company’s response:

1. Company Name

2. Point of Contact (POC) (including telephone and email address)

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

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

5. Information on any currently held government contracts to include:

a. Contract Number

b. Type of Contract

c. Contracting Agency (GSA, SEWP, etc.)

d. If you hold a current GSA schedule contract, specify which SINs are best suited for providing the services/items specified in the SOW.

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

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a. equal to or greater than the minimum required features/characteristics listed in Section 4.0

SPECIAL ORDER REQUIREMENTS.

b. the brand name equipment listed in Section 5.0 BRAND NAME PRODUCTS.

7. Provide any available pricing information.

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

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

75N91024SS6900011 Page 4 of 6 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 from July 1,2024 to June 30, 2025.

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).