Standard Toxicity Studies (STS) in minipigs
At Triskelion standard toxicity studies can be performed in minipigs (e.g. Ellegaard Göttingen minipigs) according to international guidelines and in compliance with GLP.
- Different exposure routes can be used (oral, i.m., s.c., i.d.) as well as dermal application by patch testing or semiocclusive treatment.
- Adverse effects can be monitored by clinical signs, dermal reactions or injection site reactions, ophthalmoscopy, body weight, feed intake, body temperature, hematology and clinical chemistry, urinalysis, examination at necropsy for gross macroscopic changes, organ weights, and histopathology of dermal application or injection sites and major organs.
- Kinetics and metabolism can be included.
Immunotoxicity testing in minipigs
In evaluating potential immunotoxicity in standard toxicity studies, an immune pathology review is first undertaken and if a cause for concern is identified, additional functional studies should be performed. Triskelion offers the following assays for immunotoxicity studies in minipigs:
Immune pathology signs of potential immunotoxicity
- Hematology/clinical chemistry
- Lymphoid organ weights and histology
- Lymphocyte subset analysis by flow Cytometry
Functional assays to assess potential immunotoxicity
- T cell Dependent Antibody Response (TDAR)
- Delayed type hypersensitivity (DTH) reaction
- Ex vivo lymphocyte proliferation assay
- Natural Killer cell (NK cell) activity
Respiratory administration of Pharmaceuticals
Asthma and chronic obstructive pulmonary diseases are serious illnesses of the respiratory system.
Triskelion is your pre-clinical research partner offering in vivo and in vitro services. We advise you on the research and development strategy of your drug candidate, targeted at respiratory disease, both for efficacy and safety testing. Our specialists expertise in respiratory disease models includes asthma, COPD, fibrosis, respiratory allergies and respiratory infectious diseases. Our pathology expertise of the respiratory system is renowned among our sponsors. The inhalation studies we have been performing for over 35 years inspire confidence and guarantee study results of high quality.
Why use the respiratory administration route?
- Pharmaceuticals targeting the airways can be applied at the effect site
- Non-invasive method for local and/or systemic availability
What we offer:
- Efficacy, biodistribution and toxicity inhalation studies
- Use of nebulizers and dry-powder generators
- Tailor-made study designs
- Single and repeated dose administrations from minutes up to 6 hours/day
- GLP and GLP-like studies
- Array of customized endpoints, e.g.immunology
- Incorporation of toxicity parameters, e.g.genotoxicity
A selection of read-out parameters:
- Lung pathology
- Respiratory function
- Analysis of bronchoalveolar and nasal lavage fluid e.g. cellular infiltrates and immunological markers
- Haematology, clinical chemistry, urinalysis and histopathology
- Gene expression analysis
- Oxidative stress
- DNA damage
A selection of available disease models:
- Guinea pigs
- Human 3D in vitro models combined with VitroCell’s air exposure modules
- Accurate monitoring of the inhaled concentration and particle size
- Stable test atmosphere generation with our state-of-the-art technology
- Measurements of breathing parameters during and after exposure, allowing accurate calculation of the inhaled dose
- Estimation of the deposition in the respiratory tract
Efficacy, Toxicity and Bioavailability (if applicable) can be assessed simultaneously, while the assessment of bioequivalence in comparison to other routes of administration is an option.
Triskelion has a fully equipped chemical and bioanalysis laboratory to analyse test atmospheres and blood or tissue samples (kinetics), including determination of the lung burden.
- Toxicity and efficacy performed in a single lab
- Fast turnaround times
- Tailor-made study designs
- Direct communication with our expert