Streamlining Generic Drug Immunogenicity Evaluation: EpiVax's "PANDA" Approach

Throughout the program, EpiVax adapted in silico and in vitro immunogenicity risk assessment methods, previously leveraged for vaccine and biologics assessment, to evaluate the immunogenicity of generic drug impurities. The publication outlines EpiVax's recommended "PANDA" approach, featuring case studies. Throughout the program, EpiVax adapted in silico and in vitro immunogenicity risk assessment methods, previously leveraged for vaccine and biologics assessment, to evaluate the immunogenicity...

Throughout the program, EpiVax adapted in silico and in vitro immunogenicity risk assessment methods, previously leveraged for vaccine and biologics assessment, to evaluate the immunogenicity of generic drug impurities. The publication outlines EpiVax's recommended "PANDA" approach, featuring case studies.

Since 2018, EpiVax's scientists have garnered extensive experience in supporting drug manufacturers with immunogenicity assessments for ANDA submissions to various global regulatory agencies.

Thankful for the opportunity to make an impact in this domain, the EpiVax team anticipates future opportunities to develop their expertise and offerings as the generic peptide market continues to grow. As patents for over 80 approved peptide drugs approach expiration and open the door for generics , EpiVax stands ready to play a role in this expanding landscape.

About EpiVax:

EpiVax is a 25-year-old biotechnology company located in Providence, RI. Scientists at EpiVax, are identified as leaders in the field of immunogenicity assessment of vaccines and biologics. EpiVax partners with a global roster of companies, agencies, and academic collaborators to further research in the immunogenicity space, as applied to autoimmunity, infectious diseases, cancer and beyond.

Press Contact:
Sarah Moniz
Assoc. Director, Business Development
Smoniz@epivax.com

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