Thursday, July 17, 2025 7/17/2025

Validation and Improvement of ISPRI-HCP: An Innovative Platform for Immunogenicity Risk Assessment of Process-related Protein Impurities

Award Number: R43AI174486
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/01/2023
PERIOD OF PERFORMANCE END DATE: 07/31/2025

Group Awards By:

View Award Description

Validation and Improvement of ISPRI-HCP: An Innovative Platform for Immunogenicity Risk Assessment of Process-related Protein Impurities - ABSTRACT The identification and removal of process-related protein impurities (PRPI) from biologic products is a critical step in drug development. Despite recent improvements in the purification and processing of biologics, the presence of immunogenic PRPI continue to raise concerns about drug safety and efficacy. We propose an innovative approach for assessing immunogenicity risk of PRPI using our existing ISPRI-HCP platform. ISPRI- HCP stands apart from conventional methods by utilizing a T cell approach based on the T cell epitope count and density. We hypothesize that ISPRI-HCP can accurately classify candidate PRPI impurities according to their immunogenicity risk. To test this hypothesis, we will determine the T cell immunogenicity of 8 frequently found PRPI from Chinese Hamster Ovary (CHO) cell expression systems and 5 PRPI from adenoviral vaccines. The selected PRPI classified by ISPRI-HCP cover a wide range of immunogenicity risk. Peptide pools comprised of T cell epitopes of the selected proteins will be prepared and tested for their ability to induce antigen-specific INF-g secreting T cells in assays using peripheral blood mononuclear cells (PBMCs). The overall goal of this study is to provide proof-of-concept and further improve ISPRI-HCP as a platform for predicting the immunogenicity risk of PRPI.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2023	EPIVAX INC	188 VALLEY ST	PROVIDENCE	RI	02909	PROVIDENCE	USA	Allergy and Infectious Diseases Research	000	1	2/13/2024	NEW	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $299,917 )
2023	2023	EPIVAX INC	188 VALLEY ST	PROVIDENCE	RI	02909	PROVIDENCE	USA	Allergy and Infectious Diseases Research	000	1	7/27/2023	NEW	$299,917
														Subtotal = $299,917

Grand Total All Awards = $299,917

Top

All Categories

About

Search

Reports

Data Submission

Award Information

Validation and Improvement of ISPRI-HCP: An Innovative Platform for Immunogenicity Risk Assessment of Process-related Protein Impurities

Award Number: R43AI174486

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 08/01/2023

PERIOD OF PERFORMANCE END DATE: 07/31/2025

Federal Websites

Department of Health & Human Services

HHS Operating Divisions

HHS Staff Divisions

Download A Document Viewer