Element offers comprehensive, independent assessments of drug in vitro cytotoxicity and preclinical toxicology in addition to a well-developed collection of residual and clearance assays to confirm molecular clearance in animal-derived, complex matrices, including food.
Subsequent to 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 of “first, do no harm,” biopharmaceutical companies and drug developers must demonstrate nonmaleficence and low patient risk for their candidate drugs. Drug developers rely on Element’s consultative scientists to provide independent assessments of drug in vitro cytotoxicity and preclinical toxicology studies. Element’s toxicity testing lab builds on our long history testing and formulating both biopharmaceuticals and medical devices. We can help problem solve and consult on next steps, drawing our in-depth, advanced knowledge of this space.
Our in vitro cytotoxicity testing and preclinical toxicology study services can be combined with Element’s suite of ADME service offerings, resulting in a complete framework for DMPK-toxicology studies. In addition to our combined ADME-toxicology testing, we offer an expanded collection of residual and clearance assays, which can help confirm molecular clearance in complex matrices from animal sources, including food. Collectively, these services are delivered with efficient turnaround times, quality reporting, and a complete understanding of the regulatory landscape.
In vitro cytoxicity testing
Drug developers can obtain critical insights into the effects of drug candidates on living human cells with in vitro cytotoxicity testing. While extrapolation from in vitro to in vivo is not perfectly linear, molecules that are shown to be highly toxic on cultured human cells also tend to present greater toxicity risks in patients.
Our consultative, knowledgeable teams of scientists perform in vitro cytoxicity assays per strict ISO 10993-5 cytotoxicity guidelines in our purpose-built cytotoxicity testing labs, providing valuable information about candidate drug and molecule cytotoxic concentration, as well as any adverse cellular effects related to the 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, extractables and leachables (E&L), contaminant analysis, trace elements, and beyond.
Preclinical toxicology studies
Along with in vitro cytoxicity, in vivo preclinical toxicology studies are critical to assessing the safety of a drug. In these studies, a range of drug doses is delivered by researchers using the intended administration routes, resulting in an understanding as to how living organisms respond to the drug concentrations. Once the drug is administered to animals and samples are collected from those animals, the samples can be shipped to Element for thorough analysis. Our team will then perform the preclinical toxicology studies to uncover potential organ failures or adverse effects that may translate to human patients.
When combined with Element’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: Element does not have animal storage and care facilities. Animal samples in preclinical toxicology studies must be sent to the toxicity testing lab for analysis.
Residuals and clearance assays
Measuring the presence of residual drugs and testing for molecular clearance is important for both clinical trials and food safety. While clinical trial clearance assays are a key aspect of our DMPK/ADME testing services, Element also offers clearance assays as a separate service for analyzing complex matrices from animal sources, particularly animal food products. As these residual drugs and chemicals can be detrimental to humans once consumed, Element helps determine whether residuals are present in the food product and whether they are below allowable abundance thresholds (e.g., 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.
The Element advantage
Element’s experience and in-depth knowledge of the regulatory guidelines that govern toxicity and clearance testing, in addition to our comprehensive collection of bioanalytical testing services, make Element the partner of choice for biopharmaceutical companies of all sizes, including virtual, small and mid-size, as well as large pharmaceutical organizations.
For more information about our toxicity testing lab, clearance assays, or to request a quote, contact us today.
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Element’s comprehensive bioanalytical testing services are dedicated to bringing industry-leading scientific expertise to help customers advance drug development programs.