NIIMBL's Projects and Programs

Both projects and programs are opportunities for direct member involvement to help benefit the biopharmaceutical manufacturing community, but they have some key complementary differences.

Project call program

  • Broad solicitation of projects from NIIMBL members on technical and workforce topics
  • NIIMBL committees provide recommendations for topic areas
  • All NIIMBL members can participate

NIIMBL-led programs

  • Specific coordinated projects around a strategic technical theme
  • Defined by member program participants, led by NIIMBL Program Leads and Steering Team
  • Participation is based on membership tier

Workforce programs

  • Allow academia and industry to work together, foster connections, build skills, and connect qualified candidates with job opportunities
  • Can include programs for students to gain insight into the biopharmaceutical industry and possible careers

Project call program

NIIMBL proudly funds projects that accelerate technology advancement and help improve the skills of our workforce.
  • Project calls are issued approximately annually
  • Priority topic areas for technical and/or workforce development proposals are member-driven and industry-led
  • Completed projects have affected real change in areas throughout the biopharmaceutical ecosystem, including:
    • Reducing costs and measurement time with real-time monitoring in bioreactors
    • Saving millions in facility construction costs for downstream processing
    • Developing software and hardware tools for use by the entire ecosystem in R&D labs
    • Significant cost savings in the manufacture of cytokines for cell growth

Number of Funded Projects

As of June 30, 2024

Solicitations

Current opportunities

We achieve our mission through an RFx process that aims to advance technical and workforce development projects:

  • Request for Proposals
    (RFP): A solicitation sent to the entire NIIMBL community that is to result in funding of activities
  • Request for Information
    (RFI): An open invitation for organizations to share information; not directly associated with funding
  • Request for Applications
    (RFA): A focused solicitation to particular organizations to submit an application intended to result in funding of activities

RFA: Viral Vectors Capsid Titer
RFP: Project Call 9.1
RFA: Faculty Fellows

RFA: Viral Vectors Capsid Titer

Viral Vector Capsid Titer Interlab Study (RFA2025.03)

This opportunity is now closed.

NIIMBL is pleased to announce this Request for Application (RFA) to participate in the Viral Vector Program interlab study to evaluate whether utilizing the new United States Pharmacopeia (USP) AAV9 Reference material as a calibrant can improve the accuracy and precision of AAV9 capsid titer measurements from commercial Enzyme-Linked Immunosorbent Assay (ELISA) kits.

Study Goals

  • Compare the accuracy and precision of AAV9 capsid titer measurements across multiple commercial ELISA kits when the standard curve is comprised of (1) the USP calibrant vs. (2) the kit-included standard.
  • Compare intra- and inter-laboratory variability using the USP calibrant vs. existing ELISA kit standards.
  • Support regulatory alignment and qualification of the USP calibrant for broader industry use.

Learn more

RFP: Project Call 9.1

Concept submissions for Project Call 9.1 are now closed.

NIIMBL is pleased to announce Project Call 9.1, with member- driven and industry-led priority topic areas for technical development proposals.

Technology Topics:

  • Real-Time Monitoring and Advanced Process Analytics for In-Process Control
  • Integrated Modeling and Control Strategies Linking Upstream, Downstream, and Cell Line Development
  • Novel Protein Expression Platforms for Complex and Next-Generation Biotherapeutics
  • Digital and Automation Platforms to Enhance Downstream Development and Filtration Scalability
  • Advanced AI/ML-Driven Strategies for Biopharmaceutical Process Modeling and Optimization

Workforce Development Topics

  • Stimulate Knowledge and Interest in Biopharma Manufacturing Careers
  • Accelerate Career and Leadership Advancement in Biopharma Manufacturing
  • Build an AI-Ready Biopharmaceutical Manufacturing Workforce
  • Pilot Lower-Cost Options for Biopharmaceutical Manufacturing Education
  • Catalyze Cross-Regional Workforce Development Partnerships
  • Build a Future Biopharma Workforce Through Cross-Sector Pathways

Learn More

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

  • Create a diverse and engaged community of academics that can work collaboratively and effectively with industry and represent a variety of disciplines, backgrounds, and institutions
  • Gain valuable experience and exposure to state-of-the-art biopharmaceutical manufacturing, learn about real-world industry challenges, seed new industry-academic partnerships, and strengthen the overall member community


Requirements

  • Up to 12 month sabbatical period (12 months is the preferred duration)
  • Maximum total budget of $200,000

Learn more about the Faculty Fellows Program

RFA: Viral Vectors Capsid Titerarrow down

RFA: Viral Vectors Capsid Titer

Viral Vector Capsid Titer Interlab Study (RFA2025.03)

This opportunity is now closed.

NIIMBL is pleased to announce this Request for Application (RFA) to participate in the Viral Vector Program interlab study to evaluate whether utilizing the new United States Pharmacopeia (USP) AAV9 Reference material as a calibrant can improve the accuracy and precision of AAV9 capsid titer measurements from commercial Enzyme-Linked Immunosorbent Assay (ELISA) kits.

Study Goals

  • Compare the accuracy and precision of AAV9 capsid titer measurements across multiple commercial ELISA kits when the standard curve is comprised of (1) the USP calibrant vs. (2) the kit-included standard.
  • Compare intra- and inter-laboratory variability using the USP calibrant vs. existing ELISA kit standards.
  • Support regulatory alignment and qualification of the USP calibrant for broader industry use.

Learn more

RFP: Project Call 9.1arrow down

RFP: Project Call 9.1

Concept submissions for Project Call 9.1 are now closed.

NIIMBL is pleased to announce Project Call 9.1, with member- driven and industry-led priority topic areas for technical development proposals.

Technology Topics:

  • Real-Time Monitoring and Advanced Process Analytics for In-Process Control
  • Integrated Modeling and Control Strategies Linking Upstream, Downstream, and Cell Line Development
  • Novel Protein Expression Platforms for Complex and Next-Generation Biotherapeutics
  • Digital and Automation Platforms to Enhance Downstream Development and Filtration Scalability
  • Advanced AI/ML-Driven Strategies for Biopharmaceutical Process Modeling and Optimization

Workforce Development Topics

  • Stimulate Knowledge and Interest in Biopharma Manufacturing Careers
  • Accelerate Career and Leadership Advancement in Biopharma Manufacturing
  • Build an AI-Ready Biopharmaceutical Manufacturing Workforce
  • Pilot Lower-Cost Options for Biopharmaceutical Manufacturing Education
  • Catalyze Cross-Regional Workforce Development Partnerships
  • Build a Future Biopharma Workforce Through Cross-Sector Pathways

Learn More

RFA: Faculty Fellowsarrow down

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

  • Create a diverse and engaged community of academics that can work collaboratively and effectively with industry and represent a variety of disciplines, backgrounds, and institutions
  • Gain valuable experience and exposure to state-of-the-art biopharmaceutical manufacturing, learn about real-world industry challenges, seed new industry-academic partnerships, and strengthen the overall member community


Requirements

  • Up to 12 month sabbatical period (12 months is the preferred duration)
  • Maximum total budget of $200,000

Learn more about the Faculty Fellows Program

Past opportunities

American rescue plan

NIIMBL funded 32 coronavirus response projects to multiple organizations across the United States.

Project Call 8.1

NIIMBL awarded 11 new member-led technology, workforce development, and Global Health Fund projects with a value of ~$11.2 million.

Learn about more past funding opportunities

Case studies

December 2023

Single-use Modules for Continuous Removal of Antibody Fragments

LigaTrap Technologies, LLC, Merck & Co., Inc., MilliporeSigma/EMD Serono, North Carolina State University, Rensselaer Polytechnic Institute

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August 2023

A New Generation of High-efficiency HVAC Filters that Can Be Used with Existing Infrastructure to Stop the Spread of Coronavirus Through Recirculation of Air

North Carolina State University

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August 2023

Development of a Thermo-tolerant, Multidose, Egg-produced, Vector-based Coronavirus Vaccine

PATH Center for Vaccines Innovation & Access

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August 2023

Development of Scalable, Thermostable, Spray Dried Vaccine Formulations Applicable for Coronavirus Vaccines

Fraunhofer USA

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November 2022

Noninvasive PAT for Aluminum-adjuvanted Vaccines

Merck & Co., Inc., Pfizer, Inc., University of Maryland Baltimore

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September 2022

Specific Detection of Infected Cells Using Optical Drag-Tags in Laser Force Cytology

Carnegie Mellon University, LumaCyte, Merck & Co., Inc., Rensselaer Polytechnic Institute

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NIIMBL-led programs

NIIMBL-Led Programs accelerate progress around a strategic technical theme to benefit the relevant biopharmaceutical manufacturing community.
Through these programs, NIIMBL is committed to finding solutions to key biopharmaceutical manufacturing challenges that will push the limits of what is currently possible and accelerate the speed at which we manufacture therapies.

Impacts for participants – and the entire biopharmaceutical ecosystem

  • Flexible solutions and assets that will catalyze advances across the biopharmaceutical manufacturing field, solving problems that are difficult or impossible to solve individually
  • Core standardized platforms, tools, and processes that all participants can apply to their own future projects—saving time, effort, and money
  • Interdisciplinary, cross-organizational insights that will provide industrially-relevant direction and inform strategic, specific outreach to the NIIMBL community (e.g. RFI, RFA, RFP) 

Why participate in NIIMBL-led programs?

  • Build your organization’s authority as, and connection to, industry leadership
  • Ensure the strategic direction of the industry aligns with your organization’s interests
  • Access your organization’s current state relative to others in the space
  • Access and leverage real-time “market research” and advanced technologies from a broad cross-section of the community to inform your own strategic direction
  • Help your employees/colleagues build expertise, industry awareness, and leadership skills

Big data
Process intensification
Preventive Medical Countermeasures
Viral vector manufacturing & analytics

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.

Learn more about Big Data Program

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:

  • Improved control, robustness, and security of supply
  • Dramatically reduced capital and operating cost so it is much less of a barrier to the availability of capacity, innovation, or change, and supports global access to biologics medicines
  • Flexibility of facilities and equipment to supply an extremely diverse and changing portfolio of products in the face of uncertainty and changing volume demand
  • Faster product development and supply chain velocity
  • Sustainable raw materials, components, and energy use

Learn more about Process Intensification Program

Preventive Medical Countermeasures

Mission
Accelerate the implementation of new preventive medical countermeasure manufacturing technologies across multiple platform processes by addressing workforce and technology issues that U.S. and global manufacturers and suppliers face and establishing a Center of Excellence for Vaccine Analytics and Assays.

Vision
Accelerate the production of innovative preventive medical countermeasures by ensuring that both U.S.-based and global medical countermeasure manufacturers and suppliers have adequate support to implement advanced manufacturing and product characterization processes.

Learn more about the Preventive Medical Countermeasure  Program

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.

Learn more about Viral Vectors Program

Big dataarrow down

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.

Learn more about Big Data Program

Process intensificationarrow down

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:

  • Improved control, robustness, and security of supply
  • Dramatically reduced capital and operating cost so it is much less of a barrier to the availability of capacity, innovation, or change, and supports global access to biologics medicines
  • Flexibility of facilities and equipment to supply an extremely diverse and changing portfolio of products in the face of uncertainty and changing volume demand
  • Faster product development and supply chain velocity
  • Sustainable raw materials, components, and energy use

Learn more about Process Intensification Program

Preventive Medical Countermeasuresarrow down

Preventive Medical Countermeasures

Mission
Accelerate the implementation of new preventive medical countermeasure manufacturing technologies across multiple platform processes by addressing workforce and technology issues that U.S. and global manufacturers and suppliers face and establishing a Center of Excellence for Vaccine Analytics and Assays.

Vision
Accelerate the production of innovative preventive medical countermeasures by ensuring that both U.S.-based and global medical countermeasure manufacturers and suppliers have adequate support to implement advanced manufacturing and product characterization processes.

Learn more about the Preventive Medical Countermeasure  Program

Viral vector manufacturing & analyticsarrow down

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.

Learn more about Viral Vectors Program

Workforce programs

NIIMBL is committed to helping the biopharmaceutical industry solve workforce shortages by creating awareness of biopharmaceutical careers and fostering industry and academic connections.

NIIMBL eXperience

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.

Faculty fellows

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.

Become a member

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.