Antibody and Protein Toxicology Services
Pre-clinical toxicology is a study of the toxic effects of drugs in development based on statistical and quantitative analysis. Our antibody and protein toxicology service portfolio provides you with a complete workflow to reduce the risk of your early drug discovery or later drug engineering programs. At Creative Biolabs, toxicological studies are available in rodent and non-rodent species under national and international guidelines, including:
Toxicological Studies Capabilities
Creative Biolabs is your reliable toxicology analysis partner.
For toxicology studies, we perform a wide range of tests tailored to meet diverse client needs. These include acute, subchronic chronic, and reproductive toxicity assessments. The study duration - whether short-term (acute), intermediate (subchronic), long-term (chronic), or indefinite-term (reproductive) - is determined based on the administration length required during clinical trials and the developmental phase of the test article. This can range from preclinical assessments for Investigational New Drug (IND) submissions to later-stage testing for New Drug Applications (NDA) and Biologics License Applications (BLA). This approach ensures precise alignment with regulatory requirements and clinical timelines.
Acute Toxicity
It focuses on the toxicological effects of a single large dose of the target substance.
- To determine the median lethal dose (LD50) after a single dose is administered by one or more routes, one of which is the intended route of administration for humans.
- To determine the maximum tolerated dose (MTD) and no observable level.
- To identify potential toxic target organs and determine the reversibility of toxicity and parameters for clinical monitoring.
Subchronic Toxicity
It includes repeated small doses of the test substance over up to 90 days.
- To establish an "unobservable level of influence" (NOEL).
- To characterize the dose-response relationship after repeated doses.
- To identify and characterize specific organs affected after repeated dosing.
- To help select the dose for repeated dose toxicity testing.
Chronic Toxicity
This focuses on the long-term effects of test substances.
- To characterize the dose-response relationship after repeated administration.
- To identify and characterize specific organs affected after repeated dosing.
- To assess the cumulative toxicity of chemicals.
- To assess the possibility of carcinogenesis.
Reproductive Toxicity
It focuses on the harmful effects of substances or environmental factors ranging from several weeks to several months.
To determine the potential adverse effects of test materials on mammalian gametogenesis, fetal organogenesis, childbirth, lactation, neonatal survival, vitality, and development.
Additional Details
Type of Sample
- Small molecules
- Biologics
- Antibody and Protein
- Vaccines
Species
- Rodents
- Canines
- NHPs
- Swine
Routes of Administration
- Oral
- Subcutaneous
- Intraperitoneal
- Intramuscular
- Intravenous
Pathological Capabilities
- Pathological Capabilities
- Clinical pathology
- Histology
- Immuno-histiopathology
- others
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Essential Toxicology for Biologic Therapies
Toxicology assessments are essential for biologic therapies like immuno-oncology, cell and gene therapies, and monoclonal antibodies. In compliance with global regulatory standards, Creative Biolabs ensures that all toxicology assessments adhere to stringent guidelines, offering confidence to researchers and developers as they navigate the approval process. These services are tailored to meet the complex regulatory needs of drug developers and ensure that therapeutics are safe for clinical trials.
Immuno-Oncology
Immuno-oncology therapies, such as checkpoint inhibitors and chimeric antigen receptor T (CAR-T) cell therapies, are leading innovations in cancer treatment. However, due to their immune-modulating effects, they pose risks such as cytokine release syndrome or the triggering of autoimmune reactions. Comprehensive toxicology testing is crucial to predict, evaluate, and mitigate these potential adverse effects, ensuring patient safety and improving clinical outcomes.
Cell and Gene Therapies
Cell and gene therapies involve altering cellular or genetic material to treat or cure diseases, presenting both opportunities and risks. Rigorous toxicology assessments are essential to address immediate therapeutic effects, long-term safety, and off-target genetic modifications. These evaluations also consider biodistribution, vector safety, and the potential for insertional mutagenesis to prevent unintended consequences and ensure compliance with regulatory standards.
Monoclonal Antibodies and Protein Drugs
Monoclonal antibodies (mAbs) and protein-based therapeutics are increasingly employed in the treatment of autoimmune diseases, infectious diseases, and cancers. However, their potential to elicit unwanted immune responses requires detailed toxicology assessments. These studies examine immunogenicity, pharmacokinetics, and cumulative toxic effects to ensure the safety and efficacy of these biologics throughout their therapeutic use. Toxicology assessments guide dose selection, safety monitoring, and risk management over long-term administration.
Regulatory Compliance
Toxicology studies are conducted following Good Laboratory Practice (GLP) standards to meet the requirements of global regulatory authorities, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). These assessments are vital for supporting Investigational New Drug (IND), Biologics License Application (BLA), and New Drug Application (NDA) submissions. Compliance with these stringent guidelines builds confidence in safety profiles, facilitating smoother progression through clinical trials and market approval processes.
Essential Toxicology for Biologic Therapies
Broad Sample and Species Range
The toxicology services cater to a wide array of test samples, including small molecules, biologics, antibodies, proteins, and vaccines, enabling to test various drug types and therapeutics at different stages of development. Moreover, we offer flexibility in selecting the optimal animal model based on the therapeutic target and regulatory requirements, across multiple species such as rodents, canines, non-human primates (NHPs), and swine.
Tailored Solutions
Each toxicology study is customized based on the specific characteristics of the therapeutic candidate. Whether dealing with small molecules, biologics, or cell and gene therapies, our service is designed to meet the unique needs of each drug development program. Our tailored designs allow for greater flexibility in addressing potential toxicity risks and optimize the assessment process.
Diverse Toxicology Capabilities
The toxicology service portfolio at Creative Biolabs is highly comprehensive, covering general toxicology, genetic toxicology, immunotoxicology, reproductive toxicology, and carcinogenicity assessments. Tailored to meet the specific needs of clients at different stages of drug development, our services help characterize dose-response relationships and identify the potential risks of drug candidates with precision, ensuring a clear path to regulatory success.
End-to-End Support
From the earliest stages of drug discovery through to regulatory submission, Creative Biolabs offers comprehensive support. This includes the integration of preclinical toxicology studies with other facets of the drug development pipeline, such as efficacy testing and pharmacokinetic assessment in various models.
Efficacy Models We Provide Creative Biolabs conducts both GLP and non-GLP in vivo efficacy studies to meet diverse client needs with well-designed protocols and statements of work (SOWs). Our models include cell line-derived xenografts, humanized models, immuno-deficient mice, syngeneic models, and chemical-induced cancer models.
Antibody and Protein Pharmacology Creative Biolabs' pharmacology program accelerates cancer immunotherapy development by evaluating the effects of compounds or biologics on physiological functions. We provide a comprehensive, globally aligned pharmacology program adhering to ICH guidelines.
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