Asteran specializes in preclinical research and development across oncology, dermatology, inflammation, and pharmacology, offering a comprehensive range of validated models and technologies.
In oncology preclinical studies, Asteran provides expertise in pharmacology, xenograft studies, immunotherapy, toxicology, and histopathology, using advanced models like subcutaneous, intravenous, and orthotopic implantation, supported by digital data collection and various regulatory-compliant systems.
The inflammation and dermatology preclinical research services accelerate drug development through validated wound healing, burns, and inflammation models, leveraging cutting-edge technologies like optical coherence tomography, ELISA, and immunohistochemistry. Asteran’s inflammation pharmacology includes acute and chronic models for immune-mediated diseases, while their pharmacology services span anti-infective, cardiovascular, metabolic, and fibrotic disease studies.
With capabilities in gene therapy, stem cell research, nanoparticle pharmacology, and specialized immunotherapy models, Asteran offers customized, hypothesis-driven studies that support drug discovery and translation into clinical trials.
Asteran is a leader in preclinical safety assays and toxicology studies, offering both GLP (Good Laboratory Practice) and non-GLP toxicology services to support the development of new therapeutic products across various therapeutic areas, particularly in oncology. Their comprehensive toxicology services include routine, investigative, and specialized studies that assess drug safety and pharmacokinetics across multiple species, such as mice, rats, rabbits, and larger animals. These studies cover all routes of administration, ensuring accurate assessment of test article effectiveness, safety margins, and the minimum effective dose.
Asteran’s toxicology expertise extends to the evaluation of new compounds for acute, subchronic, and chronic toxicity, reproductive toxicity, and carcinogenic potential, as well as immune-mediated responses. The studies are designed to comply with regulatory requirements and provide critical data for Investigational New Drug (IND) submissions. Advanced technologies, such as computerized digital data collection systems and histopathological assessments (including immunohistochemistry and confocal microscopy), allow for precise, real-time analysis of toxic effects on tissues. Asteran’s capabilities also include pathology data acquisition through their validated StarTox system, ensuring high-quality, GLP-compliant reporting suitable for regulatory authorities. Their robust safety assays and toxicology studies provide the foundation for understanding a compound’s safety profile, guiding sponsors through the essential steps of drug development with confidence.
Therapeutic Areas
1. Oncology
- Pharmacology & Xenograft Studies:
- Expertise in designing preclinical efficacy studies and pharmacology assessments for anti-cancer compounds.
- Methods for assessing anti-tumor agents include in vitro and xenograft models using validated cell lines.
- Models:
- Subcutaneous, intravenous, orthotopic implantation.
- Immunocompromised/immunocompetent models (knockout, transgenic, syngeneic).
- Species: mice, rats, rabbits (VX2 line).
- Customized cell lines and tumor cell lines available.
- Data Collection:
- Digital data collection system.
- Toxicology & Pharmacokinetics:
- GLP and non-GLP studies to evaluate toxicology and pharmacokinetics of oncology products across species.
- Investigation of dosage effectiveness, administration routes, and formulation comparisons.
- Histopathology:
- Tissue slide preparation and assessment for pharmacology and toxicology studies.
- Techniques: histopathology, immunohistochemistry, immunofluorescence, confocal microscopy, digital image analysis.
- GLP studies include a validated pathology data system (StarTox) for regulatory submission.
- Immunotherapy:
- Expertise in the pharmacology and toxicology of oncology immunotherapeutics.
- Experience with unpredictable effects and supporting immunotherapy development.
- Oncology Services:
- Studies include angiogenesis, gene therapy, nanoparticle and stem cell research.
- Capabilities: combination therapy, subcutaneous and intravenous tumor induction, dose maximization, pharmacokinetics, and pharmacodynamics.
- Support for clinical pathology, immunology, and specialized histopathology techniques.
2. Dermatology
- Study Services:
- Expertise in dermatology drug/device development.
- Experience in preclinical toxicology, efficacy, pharmacokinetics, and pharmacology studies for dermatological conditions.
- Validated Efficacy Models:
- Dermal burns, incision/excision wounds, UV burns, atopic dermatitis, acne, psoriasis, and inflammation models.
- Methods of Assessment:
- Optical coherence tomography, ELISA, immunohistochemistry, histology, laser Doppler, silhouette photography.
3. Inflammation Pharmacology
- Validated Models for Inflammation:
- Acute, chronic, and immune-mediated inflammation models.
- Expertise in animal models to assess inflammatory and immune-mediated diseases.
- Species used include specialized mice, rats, rabbits, dogs, pigs, and guinea pigs.
- Inflammation Categories:
- Acute inflammation (neutrophil-driven) and chronic inflammation (lympho-mononuclear-driven).
- Models: dermal, ocular, otic, systemic inflammation, LPS-induced, bacterial, chemical mediators (capsaicin, carrageenan), and cytokine-induced inflammation.
- Models for Dermal Sensitization and Hypersensitivity:
- Atopic and allergic dermatitis.
- Tests: Beuhler and Magnusson Kligman tests (GLP).
4. Pharmacology Services
- Broad Range of Capabilities:
- Expertise in drug discovery and translation processes for diverse therapeutic areas.
- Indications include:
- Anti-infective studies
- Arthritis and immune-mediated diseases
- Atherosclerosis
- Botulinum toxin studies
- Cardiovascular pharmacology
- Dermatology, fibrotic diseases, nephritis, metabolic diseases, ocular and otic pharmacology
- Stem cell and nanoparticle pharmacology
Customized Studies and Research
- Specialized Services:
- Asteran offers customized and investigative studies to meet specific client needs.
- Capabilities include hypothesis-driven models, novel methodologies, and unique research protocols.