an introduction for glp toxicology

1. GLP Toxicology & Safety Testing Vaccines are different from most medicines in that they are administered to large and mostly healthy populations including infants and children, so there is a low tolerance for potential risks or side effects. Vaccine development requires pre-clinical toxicology studies, following good laboratory practice (GLP), before first in human (phase I) use. Creative Biolabs offers our customers a series of GLP toxicology and safety testing to provide safety evidence for vaccine clinical trials and registration. Vaccines are administered to healthy humans, often in the first year of life. The demands for safety and efficacy are therefore very high. The safety assessment of vaccines is exhaustive and continuous; beginning with pre-clinical evaluation of their individual components in terms of purity, stability, and sterility, continuing throughout the clinical development phase and entire duration of use of the vaccine; including post-approval. Pre-clinical testing is a prerequisite to moving a candidate vaccine from the laboratory to the clinic and includes all aspects of testing, product characterization, proof of concept/immunogenicity studies and safety testing in animals conducted prior to clinical testing of the product in humans. The breadth and depth of safety assessments conducted at multiple levels by a range of independent organizations increases confidence in the rigor with which any potential risks or side-effects are investigated and managed. Our Services Creative Biolabs can help you with your GLP toxicology and safety testing needs. We offer assessment service using a broad range of animal models and various routes of administration. Rely on our professional team to provide a solution that aligns with your

2. program’s unique needs. Toxicology and safety testing for new vaccine pre-clinical assessment include: Single dose; Repeat doses: aims to establish a safe human dose, identify any toxicities to be monitored in trial; Immune response: aim to maximize immune response; Safety Pharmacology: aim to detect potential undesirable pharmacodynamic effects on physiological functions; Reproductive toxicology: aim to detect effect on reproduction, embryonal and fetal development; Genotoxicity: many sophisticated techniques including Ames assay, in vitro and in vivo toxicology tests, and comet assay have been developed to assess the degree of DNA damage; Toxicity due to the active ingredients or excipients; Reactions with impurities such as production substrates, and interactions between components of other vaccines administered simultaneously.         As one of the most highly respected vaccine testing laboratories in the world, Creative Biolabs is committed to help you through the assessment stages of development with our excellent preclinical GLP toxicology and safety testing. We promise rapid experimental timelines and competitive prices.