Immunogenicity Risk Assessment: In Silico, In Vitro, and What’s Next

by Elena Iemma | Aug 18, 2024 | Blog

Immunogenicity Risk Assessment: In Silico, In Vitro, and What’s Next Don’t Miss This one! Put this one on your calendar: Scientific and Regulatory Considerations for Assessment of Immunogenicity Risk … The gang will all be...

FDA Request for “Integrated Summary of Immunogenicity”

by Elena Iemma | Dec 23, 2023 | Blog

FDA Request for “Integrated Summary of Immunogenicity” So much news to share!  EpiVax Delivers! As promised, EpiVax 2.0 will be arriving in 2024, our 26th year, along with new team members and new plans to expand the range of services offered. Here...

Streamlining Generic Drug Immunogenicity Evaluation: EpiVax’s “PANDA” Approach

by Elena Iemma | Aug 10, 2023 | News

PROVIDENCE, RI, August 10, 2023 /PRNewswire/ — EpiVax Inc. announces the publication of results from a research collaboration with the Food and Drug Administration aimed at streamlining generic drug evaluations. The research, initiated in 2018 with a $1M...

FDA Webinar: Non-clinical Immunogenicity Assessment of Generic Peptide Products: Development, Validation, and Sampling

by Elena Iemma | Jan 26, 2021 | Events, Webinars

The FDA hosted a virtual workshop January 26, 2021 to provide updates and foster discussions around non-clinical assays for comparative immunogenicity risk assessment of generic peptide products. EpiVax CEO/CSO, Annie De Groot, presented an update on EpiVax’s...

FDA Awards $1.1M Contract to CUBRC and EpiVax for Validation of New Immunoinformatic Tool for Prospective Immunogenicity Assessment of Peptide Drugs and Their Impurities

by Adam | Oct 22, 2020 | News

PROVIDENCE, RI, October 22, 2020 /PRNewswire/ — EpiVax, Inc. (“EpiVax”) and CUBRC, Inc. (“CUBRC”) announced today that they have been awarded a two-year, $1.1 million contract from the Office of Generic Drugs (OGD) in the Center of Drug Evaluation and Research...