Award Notice - Celltheon Corporation Anti-Carfentanil monoclonal antibody (mAb)

THIS NOTICE OF INTENT IS NOT A REQUEST FOR COMPETITIVE QUOTATIONS INTRODUCTION: The U.S. Army Medical Research Acquisition Activity (USAMRAA) on behalf of the U.S. Army Medical Research Institute of Chemical Defense (USAMRICD) intends to negotiate on a sole source basis, in accordance with FAR 13.106-1(b)(1)(i), with the Celltheon Corporation (UEI: XBBJYPDQAU19). The Celltheon Corporation will provide Anti-Carfentanil monoclonal antibody (mAb) for use in Non-Human Primates.

PROGRAM BACKGROUND: The USAMRICD requires anti-carfentanil mAb to complete research milestones in support of a National Institute of Health (NIH) Interagency Agreement (IAA) in collaboration with the University of Washington. Work on small animals has already been completed by Dr. Pravetoni at the University of Washington, and his lab utilizing anti-fentanyl mAbs procured from Celltheon. Due to the proprietary nature of the Celltheon cells used in prior work, further work can only be done using mAbs from Celltheon due to its protein expressions and hybridoma technology.

MINIMUM ESSENTIAL CHARACTERISTICS (MECs): >4 grams of anti-carfentanil mAb in phosphate buffered saline (pH 7.4) at a concentration of >75 mg/mL Aliquoted aseptically into 5-20 mL vials sealed with septa.

Generated via Celltheon’s Chinese hamster ovary (CHO) cell line Safe for use in non-human primates (such as African green monkeys) Data package sent to USAMRICD containing viability, viable cell density, productivity trends, specific productivity, and titer prior to the stable pool generation and prior to purification.

Delivery to the USAMRICD no later than 01 June 2025 CAPABILITY: If your organization has the potential capacity to provide the required supplies, please provide the following information: 1) Organization name, address, email address, Web site address, telephone number, and size and type of ownership for the organization; and 2) a tailored capability statement addressing the particulars of this effort, with appropriate documentation supporting claims of organizational and staff capability.

If significant subcontracting or teaming is anticipated in order to deliver technical capability, organizations should address the administrative and management structure of such arrangements.

ELIGIBILITY: The North American Industry Classification System (NAICS) for this acquisition is 541714, Research and Development in Biotechnology (except Nanobiotechnology). The Product Service Code is 6509, Drugs and Biologicals, veterinary use. Each respondent must clearly identify their business size/status in their capabilities statement. THIS DOCUMENTATION MUST ADDRESS AT A MINIMUM THE FOLLOWING ITEMS:

1) What type of work has your company performed in the past in support of the same or similar requirement?

2) Can or has your company managed a task of this nature? If so, please provide details.

3) Can or has your company managed a team of subcontractors before (if subcontractors would be needed)? If so, provide details.

4) What specific technical skills does your company possess which ensure capability to perform the tasks?

5) For small businesses, please note that under a Small-Business Set-Aside, in accordance with FAR 52.219-14, the small business prime must perform at least 50% of the work themselves in terms of the cost of performance. Provide an explanation of your company’s ability to perform at least 50% of the tasks.

6) Provide a statement including current small/large business status and company profile to include number of employees, annual revenue history, office locations, SAM Unique Entity ID, etc.

7) Include in your response your ability to meet the requirements in the Facility and Safeguarding requirements.

ADDITIONAL INFORMATION AND SUBMISSION DETAILS (CAPABILITIES STATEMENT): Interested parties are requested to submit a capabilities statement of no more than three (3) pages in length in Times New Roman font of not less than 10 pitch.

1) The contract type is anticipated to be Firm Fixed Price.

2) All data received in response to this NOI that is marked or designated as corporate or proprietary will be fully protected from any release outside the Government.

3) Responses to this NOI, including any capabilities statement, shall be electronically submitted in either Microsoft Word or Portable Document Format (PDF) point of contact identified below, NO LATER THAN, 8 AUGUST 2024 12:00PM EST. POINT OF CONTACT: Benjamin Marcus Contract Specialist USAMRAA/Contracts Branch 2 Benjamin.t.marcus2.civ@health.mil