Vaccine Pre

1. Vaccine Pre-Clinical In Vivo Assessment Pre-clinical guidelines for vaccines have been produced since 1997. Pre-clinical in vivo assessments are crucial to the assessment of potency and safety of human vaccines. Efficient translation from basic research to clinical therapies will depend on the availability of appropriate in vivo models to address every problem that arises during vaccine development. Creative Biolabs offers our customers a series of preclinical in vivo assessments to provide safety evidence for vaccine clinical trials and registration. Features: Provide proof of concept and safety evidence for first clinical trial Support changes of vaccines and their use in clinical development Support registration    GLP Toxicology & Safety Testing 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 program’s unique needs. Toxicology & 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;   

2. 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.    GLP Reproductive Toxicology Studies Reproductive toxicity is a special part of toxicology which comprises any effect of vaccine components on reproduction and development (embryonal and fetal development). The investigations and the interpretation of the results should be related to all other pharmacological and toxicological data available to determine the risk of the test vaccines to humans. Creative Biolabs offers reproductive toxicology assays for your vaccines according to internationally recognized guidelines. The reproductive toxicology studies we provide: Male and female fertility Developmental toxicity (embryo-fetal development) Peri-postnatal development Multigenerational studies    

3. Genotoxicity In genetics, the components of vaccines may damage the genetic information within a cell causing mutations, which may lead to cancer. The alteration can have direct or indirect effects on the DNA. To assay for the genotoxicity, researchers from Creative Biolabs provide a range of techniques including: Ames Assay: minimum prior to single dose study Comet Assay Micronucleus test    GLP In Vivo ADME & PK Studies Absorption, Distribution, Metabolism and Excretion (ADME) studies are a crucial part of the comprehensive safety evaluation of a new vaccine. Creative Biolabs offers ADME & PK in vivo studies for our clients and various routes of administration including oral, dermal, intravenous, infusion, inhalation, intrathecal and intraperitoneal as well as other delivery options according to your needs. Available service: Dosing frequency Routes of administration Interspecies comparisons Various surgical models Pharmacokinetic / Toxicokinetic (PK/TK) Quantitative tissue distribution Micro-autoradiography Metabolite isolation and characterization Radioactivity sample analysis Bioavailability evaluation Bioequivalence studies            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 in vivo assays. We promise rapid experimental timelines and competitive prices.