Adgyl Lifesciences conducts a full range of Good Laboratory Practice (GLP) and Non-GLP vaccine studies in AAALAC-accredited animal facility. Test facility has more than 30+ years of experience in conducting vaccine safety studies using WHO protocols in various animal models: Rodent, Rabbit, Minipig and Canine. Extensive experience of handling attenuated/killed, modified and recombinant vaccine with classical and novel adjuvants, biologics, monoclonal antibodies (Mabs), Recombinant (rDNA) Proteins and Biosimilar (similar) Biologics including toxicokinetic and immunogenicity/seroconversion analysis. The Test Facility completed more than 100 GLP studies and submitted to various regulatory agencies.
- Genotoxicity (GLP) For Novel vaccine adjuvants and additives
- In vitro chromosomal aberration test in Human Peripheral Blood Lymphocytes (MUT-CHAB/HPBL)
- Micronucleus test (MNT) in mice/rats
- Safety Pharmacology (GLP)
- Pulmonary functions (rats)
- Modified Irwin Test/Functional Observation Battery in rats (FOB-rats)
- CVS function assessment using telemetered dogs
- Toxicology studies (GLP)
- Single dose Toxicity study in most relevant species (mice/rats/dogs)
- Repeat Dose Toxicity study with Recovery & Immunogenicity (mice/rats/dogs)
- Carcinogenicity Studies in rats or mice or Transgenic mice?For Novel vaccine adjuvants and additives
- Local Tolerance Study in rabbits
- Juvenile toxicity studies in rodents
- Humoral or Cell Mediated Immune (CMI) Response Assessment
- Reproduction studies (GLP)
- Fertility and early embryonic development to implantation (SEG-I)
- Prenatal developmental study (SEG-II)
- Peri-natal and post-natal developmental study (SEG-III)
