After proving basic in vitro therapeutic potential, the first goal of preclinical and clinical research is often to understand drug safety. Operating under the cornerstone bioethical principle, “primum non nocere,” or “first, do no harm,” biopharmaceutical companies and drug developers must demonstrate nonmaleficence and low patient risk for their candidate drugs.
Drug developers rely on Avomeen for independent assessment of drug in vitro cytotoxicity and preclinical toxicology studies. Avomeen’s toxicity testing lab builds on our long history testing and formulating both biopharmaceuticals and medical devices. With advanced knowledge in this space, we can help problem solve and consult on next steps.
Avomeen can further support drug safety assessments by fully integrating this work with our ADME toolkit, providing a full framework for DMPK-toxicology studies. In addition to our combined ADME-toxicology testing, Avomeen offers an expanded collection of residual and clearance assays, which can help confirm molecular clearance in complex matrices from animal sources, including food. Collectively, Avomeen can provide these services with efficient turnaround times, quality reporting, and a complete understanding of the regulatory landscape.
In vitro Cytotoxicity Testing
In vitro cytotoxicity testing provides drug developers with insight into the effects of their drug candidate on living human cells. While extrapolation from in vitro to in vivo is not perfectly linear, molecules shown to be highly toxic on cultured humans cells tend to pose greater toxicity risks in patients.
Avomeen’s cytotoxicity testing lab performs in vitro cytotoxicity assays to understand the molecular toxicity of candidate drugs and molecules, while adhering to strict standards set forth by ISO 10993-5 cytotoxicity guidelines. As a result, our team can provide information on candidate cytotoxic concentration as well as any observable adverse cellular effects associated with your drug or formulation. This supports and informs key decisions to carry a candidate or formulation forward or not.
Partners using our in vitro cytotoxicity testing can lean on our breadth of expertise and opt to expand their cytotoxicity testing to other potential risk areas in drug development, including pharmaceutical formulation, extractable and leachables, contaminant analysis, trace elements, and beyond.
Preclinical Toxicology Studies
In addition to in vitro cytotoxicity, in vivo preclinical toxicology studies represent another key mechanism for assessing drug safety. In these studies, researchers deliver a range of drug doses using the intended administration routes to understand how living organisms respond to the drug concentrations. Once drugs are administered to the animal and samples are collected, drug developers can send these sample collections to Avomeen. Our team performs the preclinical toxicology studies to uncover potential organ failures or adverse effects that may translate to human patients.
When combined with Avomeen’s in vitro cytotoxicity testing using human cells with our preclinical toxicology studies, our partners receive the most complete view of drug toxicity, short of phase 1 and 2 trials.
Note: Avomeen does not have animal storage and care facilities. Avomeen can test and analyze animal samples in preclinical toxicology studies only once sent to the toxicity testing lab.
Residuals and Clearance Assays
Measuring the presence of residual drugs and testing for molecular clearance are important exercises in clinical trial and food safety. While clinical trial clearance assays are a key aspect of our DMPK/ADME testing services, Avomeen also offers clearance assays as a separate service for analyzing complex matrices from animal sources, particularly animal food products. Since these residual drugs and chemicals can be detrimental to humans once consumed, Avomeen helps determine whether residuals are present in the food product and whether they are below allowable abundance thresholds (like safe harbor levels). Our bioanalytical lab can take your food products, be it meat or milk, and determine molecular residuals with excellent precision and extremely low limits of detection.