Vaccines

Info of Vaccines

Proof-of-concept & Early Efficacy Studies

In Vitro Assays

• Screening peptide antigens/live viruses
• In vitro immunogenicity assays

In vivo potency assays

• Immunogenicity – Humoral & Cellular
• Cytokine cascade analysis
• Challenge studies
• Bio-distribution & persistence;
• PK-TK for novel adjuvants

Product Characterization, Reagent Generation

• Purity; Impurity analysis
• Potency; Sterility
• Binding studies – affinity, avidity; ligands per particle
• Viral clearance/ inactivation
• Genomic and virus/vector DNA sequencing
• Biomarker discovery and development
• Antisera generation

Pyrogen testing

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

IND Enabling GLP Compliant Non-Clinical Safety Assessment Services

Test systems and routes of administration

Test Species

• Rats, mice, guinea pigs, rabbits, hamsters
• Dogs and Non-Human Primates, available through our collaborating test facilities

Routes of Administration

• Oral, dermal, parenteral (Subcutaneous, Intra-muscular, Intradermal)
• Other – Intranasal, inhalation
• Use of devices, such as needle-free injection devices

In vivo Toxicity Studies Supported by

• Single dose toxicity studies
• Repeated dose toxicity studies
• Reproductive toxicity assessments
• and Cellular
• Immunotoxicology
• Biomarkers
• Acute Phase Response Assessments
• Biodistribution & Persistence

Long Track-record of Vaccine Development

Studies performed at Intox have enabled clinical trials in India, Africa, Europe, Thailand, Australia, and several countries. Intox has been a preferred partner to world’s leading vaccines manufacturer since 1996, and has supported several vaccine programs. For instance, we have partnered with

• European malaria vaccine initiative (EMVI): A collaborative project between Bharat Biotech and ICGEB
• Meningitis vaccine project (MVP) - A collaborative project between PATH, Intox and Serum institute of India
• Acellular pertussis (aP), DTaP & TdaP, and rDNA Covid-19 vaccines for a Thai-French Biotech
• The first Asian mRNA Covid-19 Vaccine
• Qualifications of novel adjuvants – for International/Inter-university/ Inter-Governmental vaccine projects

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

Recombinant vaccines

• Plasmodium falciparum vaccine.
• Malaria vaccine
• 10-valent pneumococcal polysaccharide conjugate vaccine
• Recombinant epsilon toxoid vaccine (veterinary product)
• Diphtheria, tetanus and acellular pertussis vaccines (aP, TdaP/DTaP)

Safety studies on vaccines - Post COVID-19

• VLP (covid-19) vaccine
• mRNA (covid-19) vaccine
• DNA (covid-19) vaccine
• Novel malaria vaccine
• Novel leishmaniasis (live) vaccine
• Pneumococcal Conjugate Vaccine, 20-16 valent
• Immunogenicity booster studies / vaccine mixing studies
• Recombinant BCG vaccine