Search

Generic selectors
Exact matches only
Search in title
Search in content
Post Type Selectors
Search in posts
Search in pages
GET IN TOUCH
Brochure

Preclinical Safety Evaluation and Clinical Bioanalysis Services for Vaccines

Download PDF
Vaccine development follows a strict regulatory pathway, of which non-clinical safety assessment is a critical component. Aragen offers a spectra of preclinical research services at Intox, its fully owned subsidiary, which is an OECD GLP certified Test Facility, with a legacy of 25+ years. At Intox, we offer complete and customised non-clinical safety evaluation programs for your vaccine products, designed around the toxiological concerns that are unique to your kind of vaccine. These studies are conducted in accordance with Good Laboratory Practice (GLP). Besides, we also offer high precision bioanalytical support to your clinical trials.
End-to-End services enabling
successful development of vaccines
  • Product characterization
  • Proof-of-concept studies
  • IND supporting non-clinical fficacy / immunogenicity studies
  • IND supporting non-clinical safety assessment
  • Clinical sample bioanalysis
Safety studies on vaccines – Pre COVID-19
Non-recombinant vaccines
  • Influenza h1n1 inactivated vaccine
  • Influenza h1n1 live attenuated vaccine
  • Meninigitis – a conjugate vaccine
  • Meningococcal polysaccharide vaccine
  • Rabies vaccine inactivated, etc
Recombinant vaccines
  • Jaivac-1 (plasmodium falciparum
    ff2+pimspi19 formulated in montanide
    isa720).
  • Malaria vaccine
  • 10-valent pneumococcal polysaccharide
    conjugate vaccine
  • Recombinant epsilon toxoid vaccine
    (veterinary product)
  • Diphtheria, tetanus and acellular
    pertussis (dtap) vaccines, etc.
Safety studies on vaccine – Post COVID-19

(Studies performed at Intox have enabled clinical trials in India, Africa, Europe, Thailand, Australia, and several countries)

  • VLP (covid-19) vaccine
  • mRNA (covid-19) vaccine
  • DNA (covid-19) vaccine
  • Novel malaria vaccine
  • Novel leishmaniasis (live) vaccine
  • Novel covid-19 variant proof (multivalent) m-rna vaccine
  • Immunogenicity booster studies / vaccine mixing studies

Range of Assays and studies performed for evaluation of vaccines-under one roof

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
Genetic stability studies
  • Restriction endonuclease mapping
  • Southern/ Northern blotting
  • Copy number determination by qPCR
  • DNA and RNA sequencing
  • Retention of recombinant construct
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)
In vivo biosafety testing
  • Antibody production assays
  • Tumorigenicity testing
Pyrogen testing
  • Endotoxin Testing (LAL)
  • Monocyte activation testing (MAT)
  • Rabbit pyrogen test
End-to-End services enabling
successful development of vaccines
  • Product characterization
  • Proof-of-concept studies
  • IND supporting non-clinical fficacy / immunogenicity studies
  • IND supporting non-clinical safety assessment
  • Clinical sample bioanalysis
Safety studies on vaccines – Pre COVID-19
Non-recombinant vaccines
  • Influenza h1n1 inactivated vaccine
  • Influenza h1n1 live attenuated vaccine
  • Meninigitis – a conjugate vaccine
  • Meningococcal polysaccharide vaccine
  • Rabies vaccine inactivated, etc
Safety studies on vaccine – Post COVID-19

(Studies performed at Intox have enabled clinical trials in India, Africa, Europe, Thailand, Australia, and several countries)

  • VLP (covid-19) vaccine
  • mRNA (covid-19) vaccine
  • DNA (covid-19) vaccine
  • Novel malaria vaccine
  • Novel leishmaniasis (live) vaccine
  • Novel covid-19 variant proof (multivalent) m-rna vaccine
  • Immunogenicity booster studies / vaccine mixing studies
Recombinant vaccines
  • Jaivac-1 (plasmodium falciparum
    ff2+pimspi19 formulated in montanide
    isa720).
  • Malaria vaccine
  • 10-valent pneumococcal polysaccharide
    conjugate vaccine
  • Recombinant epsilon toxoid vaccine
    (veterinary product)
  • Diphtheria, tetanus and acellular
    pertussis (dtap) vaccines, etc.
× img

Contact An Expert Today!

Contact Us