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Simple Summary Nowadays, the importance of breastfeeding has been very well recognized not only by the scientific world but also by public opinion. Such awareness has nonetheless put a lot of pressure on women under chronic pharmacological medication, or that simply need to alleviate common post-partum health issues, due to the lack of scientific data regarding the potential transfer to the offspring during lactation. In such a scenario, the ConcePTION project aims at creating a trusted ecosystem that can efficiently generate and disseminate reliable evidence-based information regarding the effects of medications used during pregnancy and breastfeeding to women and their healthcare providers. Due to the need for a reliable animal species to obtain scientific data, the present review summarizes the main features contributing to the lactation process in the most commonly used laboratory animal species. Abstract The present review aims to summarize the main features of mammary gland anatomy, and the physiology of lactation and colostrum/milk in the most commonly used animal species for regulatory toxicity. The final goal is the selection of a preferred animal species to be enrolled in studies investigating the potential transfer of drugs and exogenous molecules through milk, within the Innovative Medicines Initiative (IMI) funded project ConcePTION. Reference data regarding humans were also collected and analyzed in order to highlight critical similarities and differences with the studied species. Additional practical considerations were also taken into account, such as ethical consideration regarding the chosen species which affects the group size, financial implications and technical feasibility of lactation trials (e.g., ease of sampling, volume of sampling, husbandry requirements and scientific recognition). In conclusion, the present analysis of the literature confirms the complexity of the decisional process behind the choice of an animal model for in vivo trials. For some of the evaluated species, data were either poor or missing, highlighting the necessity to generate more physiological background studies for species that are routinely used in laboratory settings. Overall, when taking into consideration ethical factors, feasible group size, milk volume and ease of milk collection, and physiological similarities with humans, minipigs seem to represent the most appropriate choice.

Purpose TV-1106 is a recombinant human albumin genetically fused to growth hormone which is intended to reduce the frequency of injections for GH therapy users. We report the safety, tolerability, pharmacokinetics and pharmacodynamics of repeated subcutaneous injections of TV-1106 in Cynomolgus monkeys. Method Cynomolgus monkeys received four weekly subcutaneous injections of 0, 5, 10 or 20 mg/kg TV-1106 and were monitored for safety signals throughout the study. Serum levels of TV-1106 and insulin-like growth factor 1 (IGF-1) were assayed. Results Treated animals showed no adverse effects or histopathological changes. TV-1106 serum concentrations showed sustained exposure to the drug. Exposure increased in a dose-dependent manner with peak concentrations at approximately 24 h post-dosing and elimination half-lives in the range of 12 to 24 h. IGF-1 serum concentrations were elevated throughout the entire study duration, indicative of the pharmacological response. There was a clear correlation between change in IGF-1 levels and dose or exposure to TV-1106. Conclusions The safety, pharmacokinetic and pharmacodynamic findings support the further development of TV-1106 as a once-weekly administered treatment for patients with GHD.