IMMUNOTOXICOLOGY/IMMUNOLOGY
Preclinical immunotoxicology studies play a crucial role in assessing the potential adverse effects of drugs, chemicals, or other substances on the immune system before they advance to first-in-human clinical trials.
Our preclinical team consists of experts with a wealth of knowledge and diverse specializations within the field of immunotoxicology. We design customized assessment programs to address your compound’s unique characteristics and needs. We provide scientific guidance, regulatory support, and precise data, facilitating the advancement of your drug candidate to clinical trials.
To explore how our immunotoxicology and immunology services can align with your drug development objectives, speak with our team of experts. They're ready to provide detailed answers and guidance to ensure your project's success.
DECADES OF EXPERTISE IN IMMUNOTOXICOLOGY ASSESSMENTS
With over 25 years of experience conducting immunotoxicology studies, we tailor our assessment programs to individual clinical candidates, aligning closely with their therapeutic pharmacology.
Our team, skilled in immunology, toxicology, and related scientific disciplines, evaluate a wide range of compounds―from lead identification to clinical trials. We focus on identifying immunotoxic effects such as immunosuppression, immunostimulation, hypersensitivity, and autoimmunity, using both in vitro assays and in vivo models.
Our immunotoxicology studies are performed in various species and involve bioanalysis and histopathology, to comprehensively evaluate the impact of a substance on the immune system and inform on:
- immunotoxic effects
- dose-response relationships
- mechanisms of action
- reversibility of adverse effects
- safety margins for first-in-human clinical trials
We ensure you move forward with your best and safest candidate, and obtain global registration for your molecule.
IMMUNOTOXICITY EVALUATION FOR DRUG SAFETY
Our bioanalytical and immunology experts collaborate to develop and validate methods that comply with FDA/ICH guidelines and GLP requirements. Preclinical sample analysis is then performed using the validated methods. We provide thorough immonotoxicity assessments using techniques like flow cytometry, immunogenicity assessments, receptor occupancy, and cytokine analysis. Our evaluations include:
- Immunophenotyping by flow cytometry
- Immunogenicity assessment
- Receptor occupancy
- Biomarkers
- Cytokine/chemokine analysis
- Complement activation, C3a, C5a, SC5b-9, CH50
- Cell-based assays (ELISpot, cytokine release assays, proliferation assays)
CUTTING-EDGE INSTRUMENTS FOR IMMUNOTOXICOLOGY STUDIES
Our bioanalytical laboratories are equipped with modern instruments to ensure accurate analyses. Our key equipment includes:
- Mesoscale S600 Electrochemiluminescence Sector Imagers
- BioTek Synergy H1 Multimode Readers
- Luminex® Systems
- BioTek EL406 Microplate Washers/Dispensers
- BD FortessaTM (5 laser, 18 colors) Flow cytometers
- BD FortessaTM (5 laser, 18 colors) Flow cytometers
- BD Biosciences FACSCantoTM II Flow Cytometers
- Immunospot® S6 Flex M2 (4 color)
- KingFisherTM Flex Magnetic Particle Processors
ENHANCING DRUG SAFETY WITH EXPERT PRECLINICAL IMMUNOTOXICOLOGY
By leveraging our expertise in preclinical immunotoxicology studies, we empower you to make informed decisions about the safety profiles of your compounds, ultimately contributing to the development of innovative and safe therapeutic interventions. Our commitment to excellence, coupled with a dedication to advancing scientific knowledge, positions us as a trusted partner in your drug development journey from discovery to regulatory approval.
If you have any questions about our preclinical immunotoxicology studies or how we can assist with your specific needs, please reach out. Our experts are here to provide guidance and answer your queries.
OUR FULL SPECTRUM OF PRECLINICAL SERVICES
Dive deeper into Altasciences' extensive range of preclinical services. From early phase development to clinical trial readiness, our comprehensive offering ensures a seamless transition through each stage of drug development.
Related Resources
Consult our fact sheet on immunohistochemistry (IHC) to learn about our immunotoxicology protocols
designed to identify systemic and/or local toxicity prior to initiation in human studies.
View this fact sheet to learn how our integrated services and bioanalytical platforms can advance your immunomodulatory drugs from preclinical to early phase clinical trials.
In this issue of The Altascientist, we take a deep dive into our approach to validating immunogenicity assays for both nonclinical and clinical studies.
