1) Biobanking and model development: Two full necropsy campaigns of 4.5-month-old wild-type Göttingen Minipigs (GMPs; 5 males, 5 females) and humanised (h) GMPs (5 males, 5 females) produced high-quality biobanks supporting immunological, transcriptomic, proteomic, and morphological studies. The molecular profiles to be generated will support the selection of the right model for safety studies. In addition, preparations for two disease-relevant models were completed: a type 1 diabetes model with established SOPs for glucose-homeostasis testing, and the humanised FcγR3B GMP model for testing human antibodies.
2) Digital monitoring & iPig platform: Biosensor and algorithm development (iPig) progressed from conceptual design to a functional intelligent housing system collecting synchronised behavioural, physiological, and acoustic data, supporting the development of non-invasive biomarkers of cardiovascular, respiratory, and neurobehavioural function. Achievements include an innovative wearable telemetry system based on a jacket with integrated 3D electrocardiography (ECG) electrodes and respiratory bands, and the prototype of a housing platform, enabling automated long-term monitoring with remote access, including a secure data-management infrastructure.
3) Immune system characterisation & immunosafety tools: For immune-system characterisation and immunosafety studies harmonised workflows for immune-cell isolation, storage, and flow cytometry across multiple tissues were established, along with refined whole-blood staining compatible with different cytometers. Specific achievements include validated reagents and advanced multi-colour panels for lymphoid and myeloid phenotyping, cytokine panels for ELISA and intracellular assays, and cytokine-release and T-dependent antibody-response (TDAR) assays. The first phase of a single-cell immune atlas began, including scRNA-seq of blood and bone marrow and optimisation of nuclei isolation from frozen tissue.
4) Safety studies & biomarker discovery: For safety studies and biomarker discovery eight compounds with known target-organ profiles were selected and dedicated study groups were formed to coordinate planning, ethics, analytical activities, and animal supply. The first study—a one-month toxicology study in GMPs with a siRNA—was completed, with standard toxicology, cytokine, complement, and miRNA analyses performed. Samples are now being prepared for transcriptomic and proteomic work. Ongoing studies include a 13-week monoclonal antibody study in WT and hGMPs, a pharmacokinetic study with tofacitinib to inform pivotal-study dosing, and a TDAR study with cyclophosphamide. In parallel, development of a microfluidic device for hepatocyte culture was initiated, supported by established hepatocyte-isolation workflows and optimisation for yield, viability, and cryopreservation.
5) Data integration, database infrastructure & FAIR implementation: For integrating multi-omics and toxicology data across preclinical species, the first operational version of the NHPig-DB, a robust, scalable, Standard for Exchange of Nonclinical Data (SEND)-compliant infrastructure, was delivered. Key achievements include a CDISC-compliant SEND schema, an SAP HANA backend extended from ProteomicsDB, integration of controlled vocabularies, and a web-based visualisation tool for interactive data exploration. A total of 37 SEND datasets from industry partners have been imported and validated. Early testing of AI-assisted querying showed the feasibility of natural-language interaction, a step toward self-service analytics. These developments provide the technical foundation for cross-species analyses and ensure alignment with FAIR (Findable, Accessible, Interoperable, Reusable) principles.
