Reproductive development and genetic toxicity studies are essential components of the safety assessment for new drugs. With years of accumulated rich control data and a professional and stable research team, JOINN’s reproductive development and genetic toxicity research department can provide clients with a full set of reproductive and developmental toxicity evaluation tests that meet the requirements of the U.S. FDA, U.S. EPA, ICH, OECD, and China NMPA guidelines.
Reproductive Toxicology Service Content
•Fertility and early embryonic development toxicity test (Seg. I, mice, rats, rabbits)
•Embryo-fetal development toxicity test (Seg. II, mice, rats, rabbits, non-human primates)
•Pre- and Postnatal development toxicity studies (Seg. III, mice, rats, rabbits)
•Enhanced pre- and postnatal toxicity studies (ePPND, non-human primates)
•Developmental toxicity screening
•Sperm morphology studies
•One-generation and multi-generation reproductive toxicity studies
•Breeding studies
•Developmental neurotoxicity studies
•Developmental immunotoxicity studies
•Sexual function detection
•Small for gestational age (SGA) models
•Whole embryo culture method—early in vitro screening of drugs
•Rodent animals
Rats (SD, Wistar)
Mice (ICR, KM, C57BL/6, transgenic mice)
•Non-rodent animals
Rabbits (New Zealand White, Japanese White)
Non-human primates (Crab-eating macaques)
•Extensive experience in standard reproductive and developmental toxicity evaluation tests (Seg. I, Seg. II, and Seg. III), with evaluation of various types of drugs including small molecules, biologics, small nucleic acids, and gene therapy products.
•The design of combined reproductive and developmental toxicity evaluation experiments for vaccines has been reviewed and approved multiple times by domestic and FDA authorities.
•Established the first evaluation model for embryonic-fetal developmental toxicity testing in cynomolgus monkeys in China, and completed several GLP ePPND tests in cynomolgus monkeys for new drug registration applications.
•Rich experience in the application of surrogate molecules and transgenic animals in the reproductive and developmental toxicity evaluation of biologics.
•Extensive experience in reproductive and developmental toxicity testing in rabbits, including Seg. I, Seg. II, and Seg. III, and with proficiency in artificial insemination techniques in rabbits.
•A mature in vitro whole embryo culture method for screening early drug developmental and reproductive toxicity.
•A standard GLP laboratory, a professional technical team, a comprehensive technical platform, and extensive evaluation experience.
Challenge: Client required full GLP DART studies for FDA and NMPA dual filing with tight timelines.
Solution: Customized rodent fertility, embryo-fetal and pre-postnatal study package, ICH S5-aligned with dual pathology review.
Outcome: Accelerated delivery of compliant report; supported successful FDA IND and CDE filing.
Challenge: Client needed NHP DART data for mAb due to limited rodent predictivity.
Solution: Cynomolgus monkey pregnant dosing and fetal monitoring per GLP.
Outcome: Regulatory-accepted data enabled global clinical trial initiation.
Challenge: Client required GLP-compliant NHP reproductive toxicity studies for a novel vaccine to meet global regulatory standards with strict data quality requirements.
Solution: Customized study protocol using cynomolgus monkeys, pregnant NHP dosing, fetal monitoring and full reproductive function assessment under strict GLP controls.
Outcome: Data accepted by FDA and EMA, enabling global clinical trial advancement for the vaccine candidate.
Note: These are representative case studies only. JOINN has completed thousands of DART studies across diverse innovative drugs and specialized formulations, leveraging our technical excellence and extensive experience to drive client R&D success and regulatory approvals.
