Vaccine Discovery,
Development and
Bioanalytical Services
Nonclinical toxicological and safety assessment are vital components of the regulatory pathway for vaccine research and development. Critical decisions such as human dose, route of administration and frequency of clinical dosing are informed by preclinical vaccine immunogenicity, efficacy and safety data.
Aragen Life Sciences, with a legacy spanning over 25 years, offers complete nonclinical evaluations, designed around the toxicological concerns that are unique to your vaccine. Aragen has been a preferred partner to some of the world’s largest vaccine manufacturers since 1996.
The Aragen Advantage:
OECD GLP compliant and AAALAC Accredited Facilities
DABT and ACVP board-certified toxicologists and pathologists
Comprehensive vaccine studies from acute and chronic toxicology to reproductive toxicology
Extensive experience with live attenuated, recombinant, nucleic acid and VLP vaccines
Data accepted by regulatory agencies in India, Africa, Europe, Thailand and Australia
All in-life, bioanalytical, pathology and histopathology are performed at Aragen
Highly experienced bioanalytical team skilled in both chemistry and biology
Summary of Vaccine Discovery, Development and Bioanalytical Services
Nonclinical and Clinical Bioanalytical Services
Immunoassay development and validation
Quantification of vaccine antigens
Acute phase proteins
Biomarker discovery and development
Biodistribution analysis of serum, organs, tissues
Advanced platforms for multiplex serotyping
Immunogenicity and Efficacy Studies
In vivo immunogenicity studies
Immunogenicity assessment
TCID50 determination
Anti-AAV antibody screening
Cytokine cascade analysis
Biodistribution and biopersistence
In vitro and in vivo efficacy studies
GLP Toxicology and Safety Assessment Studies
Single and repeat dose toxicology
Safety pharmacology
Genetic toxicology
Developmental and reproductive toxicology
Carcinogenicity
Bioanalytical method development and validation
Bioanalysis, pathology and histopathology
A comprehensive array of assays and studies are conducted under one roof for the assessment of vaccines.
In Vitro Immune Profiling Assays for Vaccine and Adjuvants Development
Screening peptide/antigen/live viruses
In vitro immunogenicity assays
Testing of novel adjuvants and antigen delivery vectors
In vivo potency assays and safety testing
Hormone potency assays, such as FSH, FSH-LH, PMSG, and hCG (EP or USP)
Vaccines, including immunopotency, immunogenicity, antisera generation, and challenge studies (bacteria/viruses)
