DEVELOPMENT OF ADVANCED MANUFACTURING CAPABILITY FOR ACTIVE PHARMACEUTICAL INGREDIENTS

W911SR-23-S-APIM

REQUEST FOR INFORMATION

development of advanced manufacturing capability for active pharmaceutical ingredients

Objective:

This is a Request for Information (RFI) for planning purposes only. It is not to be construed as a commitment by the Government nor will the Government pay for the information solicited. No solicitation document exists or is guaranteed to be issued as a result of this RFI. The Joint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical (JPM CBRN Medical) and the Joint Program Executive Office for Chemical, biological, Radiological, and Nuclear Defense (JPEO-CBRND) is seeking information on the available capabilities and willingness of private entities (academic, non-profit, and commercial) to collaborate with the Government in the areas listed below.

Background:

JPM CBRN Medical is interested in expanding the U.S. industrial base for advanced manufacturing of active pharmaceutical ingredients (APIs) to be used in medical counter measure (MCM) drug products used by the U.S. military and allies to counteract chemical and biological threats. With an advanced manufacturing approach, JPM CBRN Medical is looking for innovative and cutting-edge technology to improve products and processes. APIs used in current and developmental MCMs are typically obtained from single source, foreign (non-U.S.) suppliers. Procedures traditionally used in API production, such as large-scale batch manufacturing, involve lengthy, complex processes and intermediates which may be rate limiting. Scale up and batch manufacturing can be hazardous and involve carcinogenic agents requiring development of alternative and less efficient reaction measures. Non-military commercial markets may be small for USP grade API, thus the financial incentives can be low. These current practices make effective MCM responses at risk due to potential supply, time, and production limitations.

Requirements:

The Government is seeking white papers outlining novel approaches for a rapid acquisition plan with planned milestones to develop and deliver APIs, and potentially drug products, using advanced manufacturing, preferably within 36 months. The purpose of this RFI is to solicit information on the availability of U.S. based companies with advanced manufacturing capabilities. The APIs should meet cGMP requirements.

Performance Objectives:

1. Evaluate the Intellectual Property (IP) landscape for efficient synthetic manufacturing processes and identify potential commercial licensing opportunities for the manufacture of the API
2. Evaluate alternative synthetic routes that would have the potential to lower cost and increase manufacturing efficiency of the API and not require commercial licensing
3. Identify sources of starting materials and any reagents or catalysts required for the manufacture of API. Preference should be given for sourcing starting materials and reagents/catalysts through U.S. based companies. Material sources manufactured in the U.S. are highly desired
4. Demonstrated capability to develop, qualify, and validate analytical method for the characterization, release, and stability analysis of the API
5. Demonstrated capabilities to conduct or manage stability programs to support the development of the API
6. As the Drug Product program evolves through the phases toward licensure with the FDA, company to demonstrate capabilities to manufacture API at scales necessary for the phase of the program and, as required, scale-up API production to meet the needs including to commercial scale to meet market(s) requirements. Include discussion on how the manufacturing processes are validated
7. Demonstrated capabilities to develop and manufacture API under cGMP guidelines to meet the needs of each clinical phase of the program and eventual commercial market(s)

Regulatory Objectives:

1. FDA Compliance: The API shall meet or exceed the quality standards established by current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), Good Clinical Practices (GCP) and FDA and/or International Conference on Harmonisation (ICH) and International Organization for Standardization (ISO) standards, during the course of development
2. Quality:

The Awardee shall conduct a process efficiency study that would describe ways to improve the manufacturing control and batch release process using real-time quality assurance during the manufacturing process instead of at the completion of a batch run

The Respondents shall provide the following in reply to this RFI, not to exceed 11 pages in total:

1. Company Description (2 page maximum).

• Provide a brief description of company history, alliances and funding emphasizing experience in advanced manufacturing
• Discuss any data rights assertions anticipated for the API manufacturing process (Freedom to operate, patent application status, issued or licensed intellectual property)

1. API Advanced Manufacturing Capability Description (5 page maximum)

• Description and discussion of any or all of the capabilities described in the Performance Objectives section. Innovative approaches that address the overarching program goals that do not precisely match the above Performance Objectives can be included
• Provide a description of the design framework and methods to be used in this effort
• Discussion of the maturity of the proposed approaches, including previous demonstrated use, and any relevant FDA regulatory exposure
• Provide a high level development schedule
• Provide a Rough Order of Magnitude cost
• Provide approach to Cost of Goods analysis
• Any associated intellectual property rights or patent coverage

Administration:

The Government will retain comments and information received in response to this RFI. Proprietary information should be identified as Company Proprietary. Do not use Government security classification markings. All written responses must be received by COB on 3 Apr 2023 1600 EDST. Responses should be sent by e-mail to: usarmy.detrick.jpeo-cbd.mbx.mcs-rfi@mail.mil, AND usarmy.detrick.mcs.mbx.baa@mail.mil, with Subject Line denoting the Responding Organization and RFI Title. Material that is advertisement only in nature is not desired. If a solicitation is subsequently released based on the responses to this RFI, the first choice for an acquisition vehicle, if appropriate, will be an Other Transaction Agreement (OTA) issued either bilaterally via publicly posted Request for Prototype Proposal (RPP), and/or an RPP issued under the Medical CBRN Defense Consortium (MCDC). Respondents not already members of the MCDC are encouraged to join at www.medcbrn.org. Respondents may also inquire about the MCDC at mcdc@ati.org. In addition, respondents are encouraged to view the Medical Countermeasures Broad Agency Announcement (BAA) in SAM.gov, keywords CBRND BAA . For questions related to this RFI, please e-mail to: usarmy.detrick.jpeo-cbd.mbx.mcs-rfi@mail.mil, AND usarmy.detrick.mcs.mbx.baa@mail.mil. The Points of Contact for this RFI are Richard Totten, at Richard.w.totten2.civ@army.mil and Lee Hess, at lee.a.hess.civ@army.mil.