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Solutions Small Molecules Discovery Safety Assessment Vaccine Discovery, Development and Bioanalytical Services

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)

Genetic stability studies 

  • Restriction endonuclease mapping 
  • Southern/ Northern blotting 
  • Copy number determination by qPCR 
  • DNA and RNA sequencing
  • Retention of recombinant construct

In vivo biosafety testing 

  • Antibody production assays
  • Tumorigenicity testing 

Pyrogen testing 

  • Endotoxin Testing (LAL) 
  • Monocyte activation testing (MAT) 
  • Rabbit pyrogen test