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.