Both projects and programs are opportunities for direct member involvement to help benefit the biopharmaceutical manufacturing community, but they have some key complementary differences.
As of June 30, 2023
We achieve our mission through an RFx process that aims to advance technical and workforce development projects:
This Viral Vector Program Request for Applications (RFA) aims to fund a team to participate in its the Program’s initiative on optimizing long-read next generation sequencing (NGS) capabilities.
NEW DEADLINE: The submission deadline is April 4, 2025, at 5 pm ET.
NIIMBL is planning a special session at the 2025 National Meeting. The meeting is scheduled to be held in Washington DC from June 24-27, 2025. The special session will be a pitch session (i.e. “Shark Tank”-style) where three organizations will be invited to pitch their promising technology in front of a panel of experts. Each of the three organizations will be given 30 minutes total time consisting of a short introductory statement followed by panel question and answer. At the end of the session, a process will be used to select a winning pitch. Because only three organizations will be given an opportunity to present, this RFI is being used to help identify interested parties. The primary intended and expected type of organization would be small companies (e.g. Tier 3 industry members) with promising biopharmaceutical manufacturing-related technology. However, an academic member planning to pursue commercialization of a new technology or a large company with a promising new technology are welcome to submit information but may not be prioritized over small businesses.
Purpose of this RFI:
The submission deadline is April 7, 2025, at 5 pm ET.
RFP 8.1 includes global health, technology development, and workforce development topics. It is open to current NIIMBL members and to new members by the close of the full proposal deadline.
Be sure to download the full RFP document for information on submitting Global Health, Technology Development, or Workforce Development proposals.
Funding amount: Up to $4M for technology and workforce development projects, and an additional $1.7M available through the Global Health fund.
Technology Development Topics
Process Analytical Technology and Control for Biopharmaceutical Manufacturing
Manufacturing Platforms for Biopharmaceutical Products
Workforce Development Topics
Global Health Fund Topics
mRNA/LNP Alternatives and Lowering Cost of Goods
Submission Deadline: September 30, 2024 (5:00 PM ET)
RFP 7.1 includes both technology development and workforce development topics, with a funding amount of up to $4 million. It is open to current NIIMBL members and to new members by the close of the full proposal deadline (December 7, 2023).
Be sure to download the full RFP document for information on submitting either Technology Development or Workforce Development proposals.
Funding amount: Up to $4 million
Technology Development Topics
Workforce Development Topics
RFI 2024.1 – Universal Connectivity for In-Process Analytics in Biopharmaceutical Manufacturing – aims to gather insights and ideas regarding the development of a Universal Connectivity System for at-line/inline analytical instrumentation. This initiative looks to support NIIMBL's Big Data program in biomanufacturing.
NIIMBL invites submissions from interested parties to share information on potential solutions for a Universal Connectivity System. This system is envisioned as an OT/IT core to facilitate seamless data integration and advanced analytics within biomanufacturing processes, thus enabling data-driven decision-making and process optimization.
RFI 2024.2 – Hybrid Model Federated Learning – seeks innovative approaches that combine Federated Learning with hybrid models (combining Physics-Based and AI/ML data-driven methodologies) specifically tailored for biopharmaceutical manufacturing processes. This request aims to gather insights and concepts for achieving integration and operationalization of these models in a practical, industry-relevant context. By fostering collaboration among a wide range of stakeholders, we aim to enhance prediction accuracy of Hybrid Models for biopharmaceutical process predictions using Federated Learning and other Privacy Preserving Computing approaches. This initiative seeks to train a centralized model using community data while maintaining data privacy.
This RFI is a preliminary step to gauge interest and gather insights which may shape future studies or funding opportunities in Hybrid Model Federated Learning. This RFI is not a solicitation for funding proposals. We encourage contributions from all interested parties to become integral parts of this innovative endeavor.
NIIMBL is pleased to announce the pilot of a faculty sabbatical in industry program. The NIIMBL Faculty Fellows program provides financial support for faculty or instructional staff at universities and community colleges to pursue a sabbatical either at an industry member (Tier 1 or Tier 2) or at NIIMBL’s Headquarters (NIIMBL HQ) in Delaware to support NIIMBL-led projects.
Objectives
Requirements
Viral Vector RFA2025.1
This Viral Vector Program Request for Applications (RFA) aims to fund a team to participate in its the Program’s initiative on optimizing long-read next generation sequencing (NGS) capabilities.
NEW DEADLINE: The submission deadline is April 4, 2025, at 5 pm ET.
RFI 2025.1: "Shark Tank" Pitches National Meeting
NIIMBL is planning a special session at the 2025 National Meeting. The meeting is scheduled to be held in Washington DC from June 24-27, 2025. The special session will be a pitch session (i.e. “Shark Tank”-style) where three organizations will be invited to pitch their promising technology in front of a panel of experts. Each of the three organizations will be given 30 minutes total time consisting of a short introductory statement followed by panel question and answer. At the end of the session, a process will be used to select a winning pitch. Because only three organizations will be given an opportunity to present, this RFI is being used to help identify interested parties. The primary intended and expected type of organization would be small companies (e.g. Tier 3 industry members) with promising biopharmaceutical manufacturing-related technology. However, an academic member planning to pursue commercialization of a new technology or a large company with a promising new technology are welcome to submit information but may not be prioritized over small businesses.
Purpose of this RFI:
The submission deadline is April 7, 2025, at 5 pm ET.
RFP 8.1
RFP 8.1 includes global health, technology development, and workforce development topics. It is open to current NIIMBL members and to new members by the close of the full proposal deadline.
Be sure to download the full RFP document for information on submitting Global Health, Technology Development, or Workforce Development proposals.
Funding amount: Up to $4M for technology and workforce development projects, and an additional $1.7M available through the Global Health fund.
Technology Development Topics
Process Analytical Technology and Control for Biopharmaceutical Manufacturing
Manufacturing Platforms for Biopharmaceutical Products
Workforce Development Topics
Global Health Fund Topics
mRNA/LNP Alternatives and Lowering Cost of Goods
Submission Deadline: September 30, 2024 (5:00 PM ET)
RFP 7.1
RFP 7.1 includes both technology development and workforce development topics, with a funding amount of up to $4 million. It is open to current NIIMBL members and to new members by the close of the full proposal deadline (December 7, 2023).
Be sure to download the full RFP document for information on submitting either Technology Development or Workforce Development proposals.
Funding amount: Up to $4 million
Technology Development Topics
Workforce Development Topics
RFI 2024.1: Universal Connectivity
RFI 2024.1 – Universal Connectivity for In-Process Analytics in Biopharmaceutical Manufacturing – aims to gather insights and ideas regarding the development of a Universal Connectivity System for at-line/inline analytical instrumentation. This initiative looks to support NIIMBL's Big Data program in biomanufacturing.
NIIMBL invites submissions from interested parties to share information on potential solutions for a Universal Connectivity System. This system is envisioned as an OT/IT core to facilitate seamless data integration and advanced analytics within biomanufacturing processes, thus enabling data-driven decision-making and process optimization.
RFI 2024.2: Hybrid Model
RFI 2024.2 – Hybrid Model Federated Learning – seeks innovative approaches that combine Federated Learning with hybrid models (combining Physics-Based and AI/ML data-driven methodologies) specifically tailored for biopharmaceutical manufacturing processes. This request aims to gather insights and concepts for achieving integration and operationalization of these models in a practical, industry-relevant context. By fostering collaboration among a wide range of stakeholders, we aim to enhance prediction accuracy of Hybrid Models for biopharmaceutical process predictions using Federated Learning and other Privacy Preserving Computing approaches. This initiative seeks to train a centralized model using community data while maintaining data privacy.
This RFI is a preliminary step to gauge interest and gather insights which may shape future studies or funding opportunities in Hybrid Model Federated Learning. This RFI is not a solicitation for funding proposals. We encourage contributions from all interested parties to become integral parts of this innovative endeavor.
RFA: Faculty Fellows
NIIMBL is pleased to announce the pilot of a faculty sabbatical in industry program. The NIIMBL Faculty Fellows program provides financial support for faculty or instructional staff at universities and community colleges to pursue a sabbatical either at an industry member (Tier 1 or Tier 2) or at NIIMBL’s Headquarters (NIIMBL HQ) in Delaware to support NIIMBL-led projects.
Objectives
Requirements
NIIMBL funded 32 coronavirus response projects to multiple organizations across the United States.
NIIMBL awarded approximately $1.7M through the Institute’s Global Health Fund (GHF) for projects focused on the development of in vitro potency assays for prophylactic medical countermeasures being produced by mRNA and/or viral vector technologies.
December 2023
LigaTrap Technologies, LLC, Merck & Co., Inc., MilliporeSigma/EMD Serono, North Carolina State University, Rensselaer Polytechnic Institute
August 2023
North Carolina State University
August 2023
PATH Center for Vaccines Innovation & Access
August 2023
Fraunhofer USA
November 2022
Merck & Co., Inc., Pfizer, Inc., University of Maryland Baltimore
Mission
Accelerate the development and adoption of data-driven innovation and standards to increase the speed and resilience of biopharmaceutical manufacturing.
Vision
Data-driven technologies optimize the productivity of biopharmaceutical manufacturing and accelerate the delivery of high-quality medicines to patients.
By 2029, the PI program proposes to invent, design, demonstrate, and support commercialization of integrated biopharmaceutical manufacturing technology to transform drug substance (DS) and drug product (DP) manufacturing capability, enabling the following:
Mission
Accelerate the implementation of new vaccine manufacturing technologies across multiple platform processes by addressing workforce and technology issues that U.S. and global vaccine manufacturers and suppliers face and establishing a Center of Excellence for Vaccine Analytics and Assays.
Vision
Accelerate the production of innovative vaccines by ensuring that both U.S.-based and global vaccine manufacturers and suppliers have adequate support to implement advanced manufacturing and product characterization processes.
Mission
Develop and make broadly available a robust, economically viable, shared-access platform for the technical development, manufacturing, and characterization of AAV-based gene therapy vectors. Ensure that workforce training for this platform can integrate into existing curriculum or training models to encourage adoption, and integrate improvements into the platform based on feedback from these training programs.
Vision
A gene-based therapeutics industry capable of serving patients across the full spectrum of unmet needs—from prevalent indications to ultra-rare diseases—that has access to high-quality viral vectors without cost or speed limitations.
Big data
Mission
Accelerate the development and adoption of data-driven innovation and standards to increase the speed and resilience of biopharmaceutical manufacturing.
Vision
Data-driven technologies optimize the productivity of biopharmaceutical manufacturing and accelerate the delivery of high-quality medicines to patients.
Process intensification
By 2029, the PI program proposes to invent, design, demonstrate, and support commercialization of integrated biopharmaceutical manufacturing technology to transform drug substance (DS) and drug product (DP) manufacturing capability, enabling the following:
Vaccine manufacturing
Mission
Accelerate the implementation of new vaccine manufacturing technologies across multiple platform processes by addressing workforce and technology issues that U.S. and global vaccine manufacturers and suppliers face and establishing a Center of Excellence for Vaccine Analytics and Assays.
Vision
Accelerate the production of innovative vaccines by ensuring that both U.S.-based and global vaccine manufacturers and suppliers have adequate support to implement advanced manufacturing and product characterization processes.
Viral vector manufacturing & analytics
Mission
Develop and make broadly available a robust, economically viable, shared-access platform for the technical development, manufacturing, and characterization of AAV-based gene therapy vectors. Ensure that workforce training for this platform can integrate into existing curriculum or training models to encourage adoption, and integrate improvements into the platform based on feedback from these training programs.
Vision
A gene-based therapeutics industry capable of serving patients across the full spectrum of unmet needs—from prevalent indications to ultra-rare diseases—that has access to high-quality viral vectors without cost or speed limitations.
The NIIMBL eXperience is a hands-on, expenses-paid week-long program for college first years and sophomores to gain real-world insight into career possibilities in biopharmaceutical manufacturing.
It’s also an opportunity for NIIMBL academic or non-profit Member organizations to serve as regional lead organizations that will plan, recruit students, and run a NIIMBL eXperience program in their region.
The NIIMBL Faculty Fellows program provides financial support for faculty or instructional staff at universities and community colleges to pursue a sabbatical either at an industry member or at NIIMBL’s Headquarters in Delaware to support NIIMBL-led projects.
We offer a variety of membership options that give you the flexibility to choose your organization’s level of engagement based on technology interests and priorities.