In Vivo Toxicity

For drug development, preclinical researches including in vitro and in vivo are essential processes prior to testing a drug in humans. As a PROTAC^® service expertise, Creative Biolabs now offers in vivo toxicity assays to evaluate if the candidate PROTAC^® has the potential to cause serious harm or toxicity to humans.

Background

During drug development process, drug safety is a major question, so the safety profile of the investigated candidate drug must be evaluated to support the following clinical studies and product license approval. The conduct of safety assessment is because the foreign compound used for human body will cause some side effects when it plays the therapeutic function. For regulatory agencies, the submitted drug can receive regulatory approval when the efficacy of the drug outweigh its safety risks. One important factor of safety assessment is toxicity. Hence, evaluating toxicity in animals is a crucial part of drug discovery and development.

Introduction of In Vivo Toxicity Services

As a potential drug candidate, PROTAC^® has blossomed into a promising therapeutic small molecule drug via mediating disease-causing proteins’ degradation. To support PROTAC^® preclinical research, Creative Biolabs developed one-stop PROTAC^® service. To evaluate the safety profiles of PROTAC^®s in animal models, we offer in vivo toxicity assays from initial design to final conduct. With experienced scientists and analytical platform, Creative Biolabs provides our clients with various assays, including acute toxicity test, repeated dose toxicity test, development and reproductive toxicity, and carcinogenicity test, etc. After data analysis, we will provide PROTAC^® dosing and corresponding toxicity levels.

Fig.1 Schematic diagram of in vivo toxicity tests.

• Acute toxicity is used to describe the adverse effects of the PROTAC^®s in a short period of time (normally less than 24 hours). The main observational endpoint is mortality. We provide different dose descriptors for acute toxicity - lethal dose 50% (LD50) or lethal concentration 50% (LC50). LD50 is the statistical dose at which half of the animals are expected to die. LC50 is used for inhalation toxicity.
• Repeated dose toxicity is to characterize the adverse effects after PROTAC^®s exposure by repeated daily dosing for a specified period up to the lifespan (usually from several weeks to years). The observational effects include changes in physiology, growth or life span, morphology, and behavior. We provide different dose descriptors for repeated dose toxicity - No Observed Adverse Effect Level (NOAEL) and Lowest Observed Adverse Effect Level (LOAEL).
• Reproductive toxicity is to define the adverse effects of PROTAC^®s on sexual function and fertility in females and males.
• Developmental toxicity is to identify the adverse effects on the developing embryo or fetus.
• Carcinogenicity is to measure if the potential drug can induce cancer or increase its incidence. We provide two different dose descriptors and risk assessment of carcinogenicity - T25 and BMD10.
• Some other tests are available to fit your different needs, such as skin/eye irritation test, skin sensitization test, genotoxicity test.

We provide different disease animal models for different species. Also, normal animals are available in Creative Biolabs. The PROTAC^®s and control treatments can be provided by our clients, or we synthesize by our molecule discovery service. We provide a wide range of routes, including oral, intravenous, dermal, intraperitoneal, inhalation, intrathecal and infusion or other delivery methods for your flexible choice to best fit your project.

Highlight Features of Our Services

• A wide range of administration routes for flexible choice
• Various toxicity tests for flexible choice to fit your needs
• High efficient assays and accurate data processing platform
• Experienced scientists and complete one-stop platform

With extensive experience in drug discovery and development, Creative Biolabs has established one-stop PROTAC^® service platform and various in vivo toxicity tests can be realized. We guarantee high assay efficiency and quality data. We are committed to serving PROTAC^® preclinical research for a healthier world. Please contact us for more detailed information.