General toxicology studies the adverse effects of substances on organisms, focusing on safety, dose-response, and systemic impacts. Through advanced animal models, innovative study designs, and seamless data integration, Creative Biolabs ensures that drug candidates are evaluated for safety and efficacy before advancing into clinical phases. Our toxicology program covers preclinical-to-clinical transitions, following strict Good Laboratory Practice (GLP) standards.
With expertise across ocular toxicity, infusion toxicity, and neurotoxicity assessments, we tailor each toxicology service to meet specific client needs. These services facilitate quick access, making our customer experience seamless while enhancing therapeutic
outcomes.
Our Toxicology Services
Empowered by experienced experts and high-quality in vivo animal models from study design to data analysis, Creative Biolabs offers general toxicology studies in both rodent and non-rodent species in full compliance with Good Laboratory
Practice (GLP) regulations. In addition, we provide a wide range of alternative animal models in accordance with your specific general toxicology protocol. We offer the following services including but not limited to:
Acute, Subchronic, and Chronic Toxicity Studies
Creative Biolabs provides both acute and long-term toxicity studies, crucial for determining safety margins across different therapeutic areas. These studies span GLP and non-GLP options, offering flexibility in timelines and regulatory requirements.
Acute toxicity studies evaluate immediate effects post-administration, while subchronic and chronic assessments explore long-term exposure effects, such as cumulative toxicity. These services ensure early detection of target organ toxicity, minimizing
the risk of adverse effects during later clinical trials.
Dose-Ranging Studies
Our dose-ranging studies, including Maximum Tolerated Dose (MTD) and No-Observed-Adverse-Effect-Level (NOAEL) determinations, support regulatory submissions by identifying the highest dose that can be safely administered without toxic effects. This data
is pivotal for defining the therapeutic window and dosing schedules during early-stage trials.
Predictive Toxicology
Creative Biolabs utilizes predictive toxicology to streamline the drug development pipeline, incorporating in silico tools to predict toxicity and flag potential issues early in the discovery phase. This approach significantly reduces
the time and cost associated with drug development by prioritizing the most promising compounds for further investigation.
Additional Services
Toxicokinetics (ADME Studies)
Understanding a drug’s absorption, distribution, metabolism, and excretion (ADME) is essential for developing safe therapeutics. Creative Biolabs integrates toxicokinetics into all toxicology studies, helping to predict a compound’s behavior in the body
and ensure compliance with global regulatory standards.
Immunotoxicology and Genotoxicity Testing
We provide specialized immunotoxicology and genotoxicity testing to further enhance the safety profile of drugs, particularly cellular and gene therapies. These tests assess potential immune responses and genetic damage, ensuring that new therapeutics,
including oncolytic viruses and immune checkpoint inhibitors, are both safe and effective.
Infusion Toxicity Studies
We offer detailed assessments of drugs administered intravenously, such as monoclonal antibodies and biological drugs, ensuring that dosing and delivery methods are optimized for safety.
Ocular Development and Juvenile Toxicology Studies
These services focus on age-specific and system-specific risks, ensuring that therapeutic interventions are safe for all age groups.
Discuss Your Project
Animal Models & Administration Routes
Creative Biolabs employs a variety of animal models to support toxicology research, including both rodent models and non-rodent models. Rodent models - including mice, rats, guinea pigs, hamsters, and
rabbits - are used for rapid toxicity screening and initial studies. For more advanced safety assessments, non-rodent models like dogs, Göttingen Minipigs, and non-human primates (NHPs) are employed. These models offer higher physiological relevance,
providing critical data to support clinical trials.
To ensure relevance to real-world therapeutic scenarios, Creative Biolabs offers a broad range of administration routes:
Toxicology service from Creative Biolabs can be applied in many types of therapy, including but not limited to:
Molecular Types Testing Focus
Testing Focus
Small Molecule Therapeutics
Small modulators of the immune system, such as agonists, antagonists, and checkpoint inhibitors.
- Target organ toxicity
- Dose range finding
Macromolecular Therapeutics
Large biomolecules such as antibodies and cytokines relevant to immune pathways.
- Cytokine release assays
- Immune toxicities
Cellular and Gene Therapy
Adaptive immune cell transfer, oncolytic viruses, and advanced gene therapies.
- Dosing regimen safety
- Viral safety assessment
Vaccines
mRNA vaccines and biologics.
- Immune response profiling
- Safety in repeated dosing
Creative Biolabs leads the industry with innovative services such as Ab Lock Masking Services, a technology designed to improve the selectivity of antibody-based therapeutics. This technology reduces
off-target effects by masking antibody interactions, thereby enhancing the overall safety of these therapies. Elaborating on this innovation will help further differentiate Creative Biolabs from competitors, offering clients a cutting-edge approach
to reduce the toxicity of antibody drugs.
Why Choose Us?
With leading-edge facilities and instruments available, Creative Biolabs holds a comprehensive capability to effectively provide a broad range of general toxicology studies to provide superior results for our clients and meet their needs and goals. We
guarantee:
Quick response with a timely effective report
High quality at an affordable price
Experienced, accessible team of GLP toxicologists
Transforming GLP toxicology results via innovation
We ensure rapid access to multiple scientific and technological disciplines, which enables Creative Biolabs to be an industry leader in general toxicology services. We are dedicated to getting accurate and reliable data for IND approval within the agreed delivery timeline. Particularly, we offer innovative Ab lock masking services to help global customers improve the selectivity
and safety of antibody drugs. Please contact us for closer communication to accelerate your therapy development process.
Infusion Toxicity Studies
Genetic Toxicology
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