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Projects

NIIMBL proudly funds projects that are fast-paced, high-impact, and unique in their execution.

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

Current Project Call Program solicitations

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
RFP 7.1

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

  • Cell processing (primarily for application in cell therapies)
  • Technologies for intensified processing of therapeutic proteins
  • In-line, at-line, and online measurements for critical quality attributes (CQAs) and / or process variables
  • Analytical and manufacturing technologies for viral vector manufacturing
  • Improving reliability and quality assurance of manufacturing processes, including Big Data applications

 

Workforce Development Topics 

  • Increase Interest in Biopharma Manufacturing Careers
  • Internship and Immersion Experiences for Non-Traditional Degrees
  • Innovative Talent Pipeline Partnerships
  • Education & Training for New Technologies and/or Use of New Modalities
  • Cross Regional Collaboration


Learn more about RFP 7.1 

RFP 7.1arrow down

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

  • Cell processing (primarily for application in cell therapies)
  • Technologies for intensified processing of therapeutic proteins
  • In-line, at-line, and online measurements for critical quality attributes (CQAs) and / or process variables
  • Analytical and manufacturing technologies for viral vector manufacturing
  • Improving reliability and quality assurance of manufacturing processes, including Big Data applications

 

Workforce Development Topics 

  • Increase Interest in Biopharma Manufacturing Careers
  • Internship and Immersion Experiences for Non-Traditional Degrees
  • Innovative Talent Pipeline Partnerships
  • Education & Training for New Technologies and/or Use of New Modalities
  • Cross Regional Collaboration


Learn more about RFP 7.1 

Project Highlights

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

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

August 2023

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

PATH Center for Vaccines Innovation & Access

August 2023

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

Fraunhofer USA

November 2022

Noninvasive PAT for Aluminum-adjuvanted Vaccines

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

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

Project search

Members can login for access to additional project information, including presentations, progress updates, reports, and more.

Projects (focus area)
Member Project
NIIMBL-led Project

Filters

Continuous Countercurrent Spiral Chromatography (CCSC) – Feasibility, Demonstration and Commercialization

Development of a new device format called the spiral sorter into process development within the CCTC framework.

Rapid CHO Transcriptome Analysis for Adventitious Agent Detection

The goal of this project is to apply existing genomic analysis technologies to identify changes in miRNA expression in CHO that could be used to assay infection by adventitious agents (AA).

Bridging the Gap: A Biopharmaceutical Processing Workforce Development Continuum

This proposal seeks to increase training capacity to address the critical shortage of an appropriately trained entry-level workforce in the biomanufacturing industry. Through this proposal, three distinct academic partners (Montgomery and Bucks County Com

Workforce Expansion in Biomanufacturing Emerging Technologies

Train-the-trainer programs will be developed at colleges in key biomanufacturing regions in the US. Curriculum, standards and outcomes, SOPs, and batch records will be created and distributed to help hundreds of colleges implement new curriculum.

WORDE: A Biopharmaceutical Training Center to Promote Development of the Workforce, Outreach, Research, Diversity, and Education

Establishment of the WorDE Institute accomplished through faculty professional development and course development ultimately leading to a concentration in Biomanufacturing and Technology (BMT) at Delaware State University.

Scalable microfluidics that can address the challenge of delivery of large transgenes to therapeutic cells

To accelerate the manufacturing innovation, the goal of this project is to validate a cell engineering technology that uses a microfluidic transfection for delivery of therapeutic transgenes to four cell types of importance to the pharma industry.

Building Cooperative Biomanufacturing Workforce Training Network

BioTnet (Biomanufacturing Training Network) is a cooperative training network for the biopharmaceutical manufacturing sector. The network is made up of private and public Massachusetts-based teaching institutes that offer education and training resources

ADC Surrogates for Process Development

The team will demonstrate the physicochemical similarity of candidate fluorhead-linker conjugates to two warhead-linker conjugates in current use in ADCs: an auristatin-based conjugate (MMAE-SMCC) and a pyrrolobenzodiazepine-based conjugate (PBD-SMCC).

Inline Spiking Method for Validation of Virus Clearance in Continuous Bioprocessing

The overall objective of this project is to develop an inline spiking protocol suitable for use in the evaluation and validation of virus clearance in connected / continuous bioprocessing.

Gene Therapy Training Network (GTTN) and Instructional Transfer Platform (ITP)

The Gene Therapy Training Network (GTTN) will enable development of courses related to gene therapy, transfer of these courses to other NIIMBL members, and standardization of course content and curriculum for professionals.

Expanding AAV Process and Characterization Analytical Technologies

Gene therapies promise to become revolutionary curative treatments, yet realization of this potential requires advances in biomolecular understanding to be on par with quality standards of today’s state-of-the-art treatments (e.g., monoclonal antibodies).

A Multivariate In-Line Optochemical Sensor Platform for Continuous Monitoring of Cross-Category Process Parameters and Product Attributes in Bioreactors

This project develops a multi-attribute inline optochemical sensor platform for continuous monitoring of bioreactors at all scales. This multiplexed fiber-optic sensor platform will monitor, glucose, DO and DCO.
Showing 12 of 144 items
Projects (focus area)

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Assays

Cell and Gene therapies

Data

Drug product

Drug substance

Equipment and Supplies

Incumbent worker training

Process control

Proteins/ Antibodies

Talent/ Pipeline development

Vaccines

Continuous Countercurrent Spiral Chromatography (CCSC) – Feasibility, Demonstration and Commercialization

Continuous Countercurrent Spiral Chromatography (CCSC) – Feasibility, Demonstration and Commercialization

Rapid CHO Transcriptome Analysis for Adventitious Agent Detection

Rapid CHO Transcriptome Analysis for Adventitious Agent Detection

Bridging the Gap: A Biopharmaceutical Processing Workforce Development Continuum

Bridging the Gap: A Biopharmaceutical Processing Workforce Development Continuum

Workforce Expansion in Biomanufacturing Emerging Technologies

Workforce Expansion in Biomanufacturing Emerging Technologies

WORDE: A Biopharmaceutical Training Center to Promote Development of the Workforce, Outreach, Research, Diversity, and Education

WORDE: A Biopharmaceutical Training Center to Promote Development of the Workforce, Outreach, Research, Diversity, and Education

Scalable microfluidics that can address the challenge of delivery of large transgenes to therapeutic cells

Scalable microfluidics that can address the challenge of delivery of large transgenes to therapeutic cells

Building Cooperative Biomanufacturing Workforce Training Network

Building Cooperative Biomanufacturing Workforce Training Network

ADC Surrogates for Process Development

ADC Surrogates for Process Development

Inline Spiking Method for Validation of Virus Clearance in Continuous Bioprocessing

Inline Spiking Method for Validation of Virus Clearance in Continuous Bioprocessing

Gene Therapy Training Network (GTTN) and Instructional Transfer Platform (ITP)

Gene Therapy Training Network (GTTN) and Instructional Transfer Platform (ITP)

Expanding AAV Process and Characterization Analytical Technologies

Expanding AAV Process and Characterization Analytical Technologies

A Multivariate In-Line Optochemical Sensor Platform for Continuous Monitoring of Cross-Category Process Parameters and Product Attributes in Bioreactors

A Multivariate In-Line Optochemical Sensor Platform for Continuous Monitoring of Cross-Category Process Parameters and Product Attributes in Bioreactors
Showing 12 of 144 items

Past project calls and awards

American Rescue Plan

32
projects

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

Supporting Pharmaceutical and Bioproduction Manufacturing with a Certificate in Laboratory Techniques to Provide an Entry-Level Workforce

Pandemic Preparedness and Response

Establishing Testbeds for Biopharmaceutical Manufacturing Workforce Development

Evaluation of an Automated Vapor Phase Hydrogen Peroxide Decontamination System for Rapid, Non-Residual Decontamination of Clinical Spaces

A New Generation of High-efficiency HVAC Filters to Stop the Spread of Coronavirus

Rapid Electrophoretic Assay of mRNA Vaccine Quality Attributes

Continuous Purification for mRNA Vaccine Production: Replacing Chromatography with Adsorptive Membranes

Rapid Continuous Production of Room Temperature Stable mRNA Vaccines

LNP-mRNA Vaccine Stability: Reference Materials, Rapid Stability Assessment and Lyophilized Formulation Development

Advanced Characterization and Manufacturing for mRNA Vaccines

Productivity and Quality of mRNA Vaccines

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

Accelerating the Manufacture and Scale Up of Virus-like Particle Vaccines

Development of a CHO-based Upstream Process for Rapid Production of Coronavirus Antigen Variants

Affinity Precipitation Purification of Virus-Like Particles

Spectro-acoustic Process Analytical Technology for Continuous Manufacturing of Coronavirus Vaccine

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

Thermostabilize Coronavirus Vaccines: Formulation and Process Development and Rapid Scale-up Through Modeling and QbD Experimentation

Development of SARS-CoV-2 NGS Internal Standards to Ensure Sufficient Complexity Capture for Variant Detection and Diagnosis

Rapid Single-use PCR-based Nucleic Acid Testing

A Bioelectronic Sensor for Rapid Assessment of Antibody Titer and Glycan Structure

Noninvasive Detection of Counterfeit and Substandard Vaccines and Biotherapeutics

Spike Identification Nanobody Panel for SARS-CoV-2 Vaccine Manufacturing

Open-Source Lentiviral Vector and Adenoviral-Associated Viral Vector Manufacturing

Monoclonal Antibody Expression in Fast Alternative Hosts: Demonstration & Reference Material

Production of NIIMBL’s Antibodies in the Thermothelomyces Heterothallica Cl Expression Systems

Enhancement of the End-to-End Manufacturing Testbed for Fast, Flexible Drug Substance Manufacturing (Part of the Process Intensification Program)

Next Generation Sequencing Test Bed

Portable GMP Plasmid Production Testbed

NIIMBL Vaccine Analytics and Assays Center of Excellence

Process Development Testbed

GMP-like Drug Product Testbed Laboratory

CARES Act

11
projects

NIIMBL awarded approximately $8.9M for technology innovation projects to support the U.S. response to the COVID-19 pandemic.

Provide virus proteins to improve testing capabilities (3 projects)

Title: Development of a SARS COV-2 Polyvalent Microbead Immunoassay (MIA)

Participants: Wadsworth Center (Lead), MassBiologics

Impact: This project will generate critical reagents and establish a robust serology-based assay to measure SARS COV-2-specific, virus-neutralizing antibodies in human blood. The assay will have a direct impact on the federal response to COVID-19 on three fronts by enabling: (i) the identification of COVID-19 convalescent patients willing to serve as donors for antibody therapies (ii) the screening of quarantined health care workers who wish to return to service; and (iii) serving as a benchmark in ongoing and forthcoming vaccine trials to assess vaccine efficacy.  

Title: Biomanufacturing and Implementation of Sensitive Quantitative COVID-19 ELISA Platform to Identify Sera Needed for Plasma Therapy

Participants: Johns Hopkins University (Lead), Rensselaer Polytechnic Institute, ProMechSys-RLP, Sartorius, MilliporeSigma, National Institute of Health

Impact: The goal of this project between JHU, RPI, ProMechSys, and Sartorius, along with collaborators at NIH and MilliporeSigma, is to implement advanced biomanufacturing technologies to develop a quantitative ELISA to test sera to screen for the best candidates for plasma donations. The team will produce and purify the SARS-CoV spike (S) protein and receptor binding domain (RBD) protein and incorporate these antigens into a quantitative ELISA assay to evaluate convalescent sera from volunteers.  

Title: Emergency Production of Covid-19 Spike Protein for Therapeutic Antibodies and Diagnostics

Participants: Texas A&M University (Lead), Army Futures Command, Army Research Lab-South

Impact: This NCTM-led project addresses the urgent need for key SARS CoV-2 viral proteins that can be used in assays to measure protective antibody responses in serum samples. This project will determine the best route for making and scaling up production of the spike protein and the receptor-binding domain portion of the spike protein from a transient transfection cell platform. 

Enhanced Testing Capabilities (2 projects)

Title: Increased Throughput for COVID-19 Diagnosis Utilizingthe Roche cobas® 6800Real-Time PCR and Detection System

Participants: University of Delaware (Lead), Christiana Care Health System (CCHS)

Impact: NIIMBL and CCHS will develop, validate and implement a Laboratory Developed Test (LDT) for COVID-19 utilizing the Roche cobas® 6800 omni Utility Channel real-time PCR system and therefore reduce turnaround time on PCR testing for patients and employees in healthcare settings.  

Title: Designing a Test Kit Supply Chain in Response to COVID19

Participants: North Carolina State University

Impact: This project aims to develop a supply chain mapping of testing kits and capacity, by generating the following deliverables: (1) A mapping of the supply chain for both virus and antibody test kits, from first-tier suppliers through final distribution to testing sites. (2) Development of a supply allocation model for distributing of test kits based on a rationale and logic for prioritizing testing needs across the U.S. (3) A protocol for updating deliverables (1) and (2), employing forecasting techniques to estimate the demand for test kits given various network scenarios and updated supply and demand conditions.

Identify alternative domestic supply chains to reduce foreign dependence for respirators and masks

Title: Production N95 and Surgical Masks at the Nonwovens Institute (NWI), NC State

Participants: North Carolina State University

Impact: This project is aimed at reducing the shortage of high filtration efficiency surgical masks and respirators needed to fight the spread of COVID-19. In a first aspect it will do this by enhancing NWI’s newly developed novel spunbond hydro-entangled high filtration efficiency filter media that will be suitable for the production of surgical masks or N95 respirators. This new development has the potential to increase rapidly the total availability of suitable filter media by opening the door to use higher throughput processes such as the spunbond.  This approach will also provide a strong cleanable filter medium that will allow for the design of a potentially re-usable high filtration efficiency mask or respirator. An aspect of this project relates to enhancing a high filtration efficiency filter medium that can be cut & sewn to make surgical masks or disposable insert for re-usable masks.  

Validate the use of environmental decontamination approaches for clinical spaces

Title: Validation of the Use of Vapor-Phase Hydrogen Peroxide as a Rapid Viral Decontamination Agent for Clinical and Public Spaces

Participants: PMT, Inc.

Impact:  This project will be a joint effort between PMT (USA) LLC and Solvay of Houston, TX to complete and document the United States Environmental Protection Agency (EPA) Product Performance Testing Guideline EPA OCSPP 810.2100, Efficacy Testing for Sterilants, Sporicides, and Decontaminants for Humidity Controlled Vapor Phase 35% Hydrogen Peroxide as a pesticide for room decontamination. The result will be a clean, simple, fast, minimally-invasive and safe method for decontaminating public spaces that can be rapidly deployed through licensing to the existing network of service providers currently conducting disinfection activities.

Accelerate development of more flexible manufacturing platforms of biologic therapies and rapid release testing (2 projects)

Title: Next Generation Sequencing Test Bed for Rapid Release of Biopharmaceutical Products for COVID-19 Response

Participants: NIIMBL

Impact: This Next Generation Sequencing (NGS) test bed will be used to test for adventitious agents in process streams from vaccines, therapeutic proteins including mAbs, and cell and gene therapy products on an accelerated schedule. 

Title: End-to-End Manufacturing Test Bed

Participants: NIIMBL

Impact: The End-to-End Manufacturing Test Bed will represent a platform integrated/continuous process to make a non-proprietary mAb. It will be used to accelerate maturation and adoption of protein therapeutic manufacturing technologies by testing those technologies in the context of a full process and providing standard feedstocks for experiments at other locations. 

Development of anti-SARS-CoV2 antibodies (2 projects)

Title: Development of an anti-SARS-CoV2 antibody formulation

Participants: MilliporeSigma

Impact: The objective of this project is to support the development of high concentration formulations for the target monoclonal antibody, Centi-B9, which is a potential therapeutic for the treatment of COVID-19. The project aims to identify conditions that result in ≥150 grams/liter concentration of purified protein after capture and viral inactivation and formulation, with the generation of a formulation studies report. 

Title: Development of anti-SARS-CoV2 antibodies for Army Research Laboratory-South to perform a developability assessment

Participants: Evotec Biologics, Army Research Laboratory, South

Impact: The objective of this project is to screen a large panel of SARS-CoV-2 neutralizing antibody sequences in silico using the Just – Evotec Biologics Abacus™ system to rank order those antibody sequences based on developability. The work was completed by evaluating 53 antibody sequences. Antibodies were then rank ordered and modeled. The top ranked candidates will be pursued for clinical scale and commercial manufacturing after variant of concern testing of manufacturable antibodies.  

Project Call 6.1

3
projects

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 vaccines being produced by mRNA and/or viral vector technologies.

Versatile Platform for Speed and Simplicity in mRNA Potency Testing Draft

Advanced FISH Assay and Mechanism Hybrid Surrogate to Improve mRNA Vaccine Potency Assessment and Prediction Draft

Optimization of a mRNA Vaccine Potency Assay Platform for Global Use 

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