As a leading GLP-compliant preclinical CRO in China, JOINN Laboratories’ Reproductive and Developmental Toxicology (DART) platform sets the industry benchmark with unparalleled technological innovation and extensive project expertise. We pioneered multiple novel DART assays and evaluation methodologies that fill critical industry gaps, leading domestic technical standards. Backed by over a dec
ade of hands-on experience delivering thousands of GLP-compliant DART studies across all drug classes, our platform strictly adheres to FDA, EMA, NMPA, ICH M3(R2) and S5(R3) global guidelines. With a board-certified expert team, proprietary SOPs, dedicated non-human primate (NHP) models and full-cycle closed-loop quality control, we provide comprehensive, audit-ready, regulatory-compliant reproductive toxicity assessment to de-risk drug development and accelerate global IND/NDA filings.
◇ GLP-Compliant Reproductive and Developmental Toxicology (DART) Studies
Reproductive and developmental toxicity (DART) assessment is a mandatory regulatory requirement to evaluate potential impacts of test articles on fertility, embryonic development, fetal survival and postnatal growth. JOINN’s DART platform leads the industry with groundbreaking technical capabilities and unmatched project experience: we developed first-of-a-kind evaluation protocols for specialized drugs and models, addressing unmet industry needs; with thousands of completed GLP DART studies spanning small molecules, biologics, CGT and vaccines, our robust quality system delivers precise risk identification and authoritative, globally regulatory-compliant reports.
This study assesses potential effects of test articles on mating performance, fertility and pre-implantation embryonic development in parental male and female animals. Under standardized GLP conditions, we conduct systematic evaluation of reproductive organs, sex hormone levels, conception rate and viable embryo count, scientifically determining reproductive system injury risks with fully traceable, ICH-aligned data.
• Parental male/female reproductive function assessment
• Conception, implantation and viable embryo count analysis
• Reproductive organ histopathology evaluation
• Quantitative sex hormone analysis
This key study evaluates test article impacts on embryo implantation, fetal morphogenesis and organogenesis during gestation, identifying teratogenic risks. Our platform features standardized pregnant animal modeling, fetal dissection, specimen preparation and malformation identification, with advanced imaging and data analysis systems. We specialize in biologic and macromolecule embryo toxicity assessment, with data validated by FDA and EMA inspections.
• Pregnant animal dosing and gestational monitoring
• Fetal external, skeletal and visceral malformation examination
• Embryonic resorption, abortion and stillbirth rate analysis
• Fetal growth parameter quantitative assessment
Pre- and Postnatal Developmental Toxicity Study
This study evaluates test article effects on late gestation, parturition, lactation and postnatal offspring growth, survival, neurobehavior and adult fertility. We establish standardized long-term offspring rearing and monitoring protocols, covering full-cycle developmental risks to support clinical safe use data.
• Maternal gestation, parturition and lactation safety assessment
• Offspring growth and weaning survival rate evaluation
• Offspring neurobehavioral function testing
• Adult offspring fertility and long-term toxicity tracking
For chronic-exposure or genotoxic risk compounds, we conduct multi-generational reproductive toxicity assessment to evaluate cumulative effects across parental, filial and grandfilial generations. Our platform delivers standardized breeding, long-term dosing and full-cycle testing per GLP, revealing transgenerational reproductive risks for chronic-use drugs.
• Multi-generational animal breeding and continuous dosing
• Reproductive and developmental parameter testing across generations
• Long-term reproductive organ histopathology
• Transgenerational toxicity risk comprehensive analysis
NHP Reproductive Toxicity Study (Cynomolgus Monkey)
Non-human primates (cynomolgus monkeys) share high reproductive physiology homology with humans, ideal for biologic, CGT and vaccine DART assessment. JOINN operates standardized NHP housing and testing facilities with dedicated SOPs, led by senior experts to conduct pregnant NHP dosing, fetal monitoring and reproductive function evaluation, enhancing global regulatory acceptance.
• Cynomolgus monkey fertility and embryonic development assessment
• Pregnant NHP dosing and fetal monitoring
• NHP reproductive hormone testing
• NHP reproductive organ histopathology
In Vitro Reproductive Toxicity Alternative Assays
We offer GLP-aligned in vitro alternative assays to accelerate R&D and reduce in vivo testing costs, including whole embryo culture and germ cell toxicity testing, enabling early reproductive risk screening per international 3R principles.
• Rodent whole embryo culture assay
• In vitro germ cell toxicity evaluation
• In vitro teratogenic risk screening
• Technological Pioneering: Pioneered multiple novel DART assays and innovative evaluation systems, filling domestic industry gaps and setting technical benchmarks
• Extensive Project Expertise: 10+ years of specialization, thousands of GLP-compliant DART studies across all drug classes and regulatory scenarios
• Global Regulatory Compliance: Aligns with ICH S5(R3), FDA, EMA, NMPA; full GLP quality control, audit-ready reports accepted worldwide
• Full Species Coverage: Rodent (rat/mouse) + NHP (cynomolgus monkey) models, with leading NHP DART capabilities in the region
• Top-Tier Expert Team: Industry-leading DART specialists, cross-disciplinary toxicology-pathology-breeding collaboration for rigorous data quality
• Advanced Audit-Ready Facilities: SPF animal facilities, dedicated pregnant animal housing, fetal specimen analysis labs with full traceability
• Customized Solutions: Tailored protocols for small molecules, biologics, CGT, vaccines; expedited timelines and interim data delivery available
Case 1: Innovative Small Molecule DART Program
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.
Case 2: NHP Reproductive Toxicity for Monoclonal Antibody
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.
Case 3: NHP Reproductive Toxicity Assessment for Vaccine
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.
A: Per FDA, EMA, NMPA and ICH guidelines, DART is mandatory for drugs intended for reproductive-aged, pregnant or lactating populations; long-term drugs may require multi-generational studies.
A: Rodent fertility + embryo-fetal: 4-6 months; pre-postnatal: 6-8 months; multi-generational: 12-18 months; NHP: 8-12 months. Expedited options available.
A: Yes, all studies follow GLP and ICH/FDA/EMA guidelines, with full audit trails for global IND/NDA submissions and multiple successful regulatory inspections.
A: Yes, we have extensive experience with biologics, CGT and vaccines, with tailored protocols for unique mechanisms and administration routes.
A: Yes, we provide interim study data and progress reports to align with client R&D timelines, enabling timely development strategy adjustments and accelerating overall project timelines.
A: Yes, our proprietary in vitro assays (whole embryo culture, germ cell toxicity testing) enable early reproductive risk screening to optimize lead compounds and reduce R&D costs.
A: We support full-spectrum DART assessment for small molecules, biologics, cell and gene therapies, vaccines and specialized formulations, with tailored protocols for unique drug properties and mechanisms.
A: The majority of pharmaceuticals being developed should be assessed for all stages of the reproductive cycle identified above, although there can be some exceptions which should be justified, as indicated below. To support clinical development, these stages have typically been evaluated using three in vivo study types: 1) a fertility and early embryonic development study (FEED - stages A and B), 2) embryo-fetal development studies in two species (EFD - stages C and D), and 3) a pre- and a postnatal development study (PPND – stages C through F). For each compound, the stages that are to be evaluated should be determined and the most appropriate studies to conduct should be identified.
A2: Although three separate study designs, i.e., FEED (stages A and B), EFD (stages C through D) and PPND (stages C through F) have been employed to develop the majority of pharmaceuticals, various combinations of these study designs can be conducted to reduce animal use. The main advantage of combination designs is that all relevant stages of the reproductive process can be assessed using fewer animals. Combination studies can also better mimic the exposure duration in the clinic, especially for drugs with long half-lives. A common combination study design is a combined FEED and EFD study (stages A through D) with a separate PPND study (stages C through F). In cases where no effects on male or female fertility are anticipated, or where extending the dosing period is appropriate due to observation of reproductive organ toxicity in a repeated dose toxicity study, a combination design of repeated-dose and fertility studies can be considered. After a defined dosing period within the repeated-dose toxicity study, males can be paired with sexually mature females (whether untreated, or dosed for at least two weeks prior to mating). This combination study can reduce the number of animals used, but the number of mating pairs per group should be at least 16. Further, if treated, dosing of females can be extended until the end of organogenesis, thereby allowing evaluation of EFD endpoints.
