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 our customers a series of GLP reproductive toxicology studies according to internationally recognized guidelines.

Reproductive and Developmental Toxicity

Vaccines play an important role in preventing human birth defects by protecting pregnant women from teratogenic or other harmful infections. So far, preclinical developmental toxicity testing for new vaccines are not commonly performed. Despite the excellent safety record of vaccines, there is an increasing attention now on the feasibility of screening new vaccines for developmental hazards in animals before their use in humans. Contrary to previous hypotheses, preventative and therapeutic vaccines are increasingly used during pregnancy and present special considerations for developmental toxicity testing. It is also necessary to test the developmental effects of any new components of the vaccine formulation including adjuvants, excipients, stabilizers, and preservatives. In addition, there is a need to evaluate the postnatal development and the possible adverse effects of the induced antibodies on fetal. The FDA released guidance documents on preclinical testing of preventative and therapeutic vaccines for developmental toxicity in 2006. Pre-clinical studies aim to assess the potential impact of the vaccines on prenatal and postnatal development.

The immunity given after vaccination persists for years. Thus, the developing conceptus may theoretically be exposed to induced antibodies and/or sensitized T cells, even if the pregnant woman was last vaccinated during her childhood, especially if she encounters the antigen during pregnancy through exposure to infection. Pre-clinical safety studies can be used as an aid for hazard identification. In these studies, the interaction of the vaccine with the maternal immune system or with the developmental system of the offspring are considered. Post- natal examination is necessary to detect all possible developmental toxicological manifestations, such as the effects on the immune system. The selection of species for preclinical studies is based on the relative timing and rate of immunogenicity of the vaccine and the transfer of maternal antibodies to offspring.

Our Services

Creative Biolabs offers reproductive toxicology assays for your vaccines according to internationally recognized guidelines. The reproductive toxicology studies we provide:

• Female reproduction: Oogenesis (histology), menstrual cyclicity, endocrine status (LH, FSH, CG, prolactin, estrogens, progesterone, androgens, inhibins), and fertility;
• Male reproduction: Spermatogenesis (histology, daily sperm production, spermatogenic stages), sperm maturation, semen parameters, testis size/biopsy, endocrine status (LH, FSH, prolactin, estrogens, progesterone, androgens, inhibins), prostate status, and fertility;
• Developmental toxicity (embryo-fetal development);
• Pre- and post-natal development toxicity studies;
• Multigenerational studies.

Regulatory toxicology studies need to be designed to detect any potential reproductive toxicology of all components contained in the vaccine including antigens, vehicles, preservatives, and adjuvants. Rodent species are preferred, but may not exhibit an immune response to the vaccine. The choice of species will also be influenced by the timing and relative rates of maternal antibody transfer before and after birth and the need to mimic human exposure. These unique considerations will inevitably lead to the use of innovative experimental procedures with respect to the routine research designs commonly used in new drug safety assessments. 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 GLP reproductive toxicology studies. We promise rapid experimental timelines and competitive prices!

All of our products can only be used for research purposes. These vaccine ingredients CANNOT be used directly on humans or animals.