Scantox offers a comprehensive suite of services to evaluate vaccine candidates’ safety and efficacy in the preclinical discovery phase. Our integrated approach employs in vivo and in vitro methodologies.
The combination of agility and in-depth expertise in infectious diseases and immunology allows us to solve complex vaccine development challenges and accelerate your progress from the lab to the clinic.
Core Study Types
Immunogenicity Studies
We support vaccine R&D through comprehensive immunogenicity testing, which evaluates the immune responses following immunization. Our scientists work closely with customers to establish a development plan that includes selecting the optimal animal model and analytical methods. A clear strategy ensures precise monitoring and a thorough understanding of your vaccine’s impact on the immune system.
Our tests address critical questions of new vaccine formulations:
- Does it boost immunity without triggering harmful hyper-inflammatory reactions?
- Is it immunogenic at all tested dose levels?
- Does it elicit significant and specific humoral and/or cell-mediated immune responses?
- Can it stimulate T- and B-cell responses through different delivery routes?
Challenge and Protection studies
Following positive immunogenicity results, we conduct efficacy or challenge studies. Customers can select from standard or custom infectious challenge models (see below). Studies can range from small pilot studies to larger complex study designs.
In vivo testing is vital for simulating the natural course of infections and evaluating the efficacy of vaccine candidates. Controlled animal models also provide critical data needed for first-in-human trials.
Safety Evaluations
We perform regulatory toxicology studies tailored for vaccines adhering to the highest GLP standards.
The process includes Maximum Tolerated Dose (MTD) and Dose Range Finding (DRF) studies to determine the appropriate dose levels for subsequent toxicity studies. General toxicity assessments include clinical observations such as health status, local tolerance, body temperature, clinical pathology, ophthalmoscopy, necropsy, and full histopathology.
Advanced Technical Solutions
In Vivo Animal Models
We provide infectious disease animal models for all common vaccine types: live/attenuated, subunit, and nucleic acid-based. Our state-of-the-art vivariums allow testing of pathogens up to Biosafety Level 3 (BSL3).
Clients can choose from ready-to-go or custom animal models:
- Ready-to-go models: Include disease-specific models for virology (e.g., SARS-CoV-2, Langat virus,) and bacteriology (Tuberculosis, Acne, Infected wounds, urinary tract infection).
- Customized models: Tailored to meet specific vaccine development needs. We work closely with clients to select the most suitable host species (based on the vaccine’s nature) and determine the best sample analysis methods.
Our comprehensive capabilities include a variety of animal species and dosing routes to support diverse research needs:
Animal Species
Rat, Mouse, Rabbit, Hamster, Guinea pig, Ferret, Minipig, Cow (immunogenicity and toxicology only), Horse (immunogenicity and toxicology only)
Dosing Routes
Oral (gavage, capsules, diet), Subcutaneous (including infusion), Topical, Intradermal (infusion), Intramuscular, Intravenous (bolus and infusion), Intraperitoneal, Ocular (topical, intravitreous), Airway (intranasal, intratracheal), intralymphatic, Intravaginal, Urinary bladder instillation, IntracerebralSampling Techniques
Blood sampling, Bronchoalveolar lavage, Nasal lavage, Vaginal sampling, Saliva sampling, Urine sampling, Faecal sampling, CSF, All tissuesIn Vitro Methodologies
In vitro assays are critical for assessing the immune response post-immunization. Depending on the stage of your project, we offer ready-to-use methods, method transfers, and the development and validation of fit-for-purpose methods.
Technical solutions to monitor both humoral and cell-mediated immunogenicity, as well as potential hyper-inflammatory reactions, include:
- Ligand binding assays (ELISA): for detecting vaccine-specific antibodies, neutralizing antibodies, and soluble biomarkers such as those indicative of a cytokine storm
- Cell-based assays (ELISPOT): for assessing T-cell activation and measuring intracellular IFN-gproduction
Samples can be analyzed by our Bioanalysis Department if required.
Why Choose Us?
Choosing Scantox means collaborating with scientific experts familiar with the complexity of infectious diseases. They prepare and adapt our services based on a deep understanding of your vaccine development and broader business objectives. Our rigorous processes facilitate fast study approvals and rapid initiation, keeping your project on schedule.