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Clearance Assays & Toxicity Testing

We provide 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. Collectively, these services are delivered with efficient turnaround times, quality reporting, and a complete understanding of the regulatory landscape.

Drug developers rely on our consultative scientists to provide independent assessments of drug in vitro cytotoxicity and preclinical toxicology studies. Our toxicity testing lab builds upon a long history testing and formulating both biopharmaceuticals and medical devices. We problem solve and consult on next steps, drawing our in-depth, advanced knowledge of this space.

In vitro cytotoxicity testing and preclinical toxicology study services can be combined with our complement 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. Get a quote from our toxicity testing lab today.

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 to 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. Need support determining the safety of your drug candidate? Start the conversation.

    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 us 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. Get a quote for preclinical toxicology studies today.

    Note: We do 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, we also offer 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, we help 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, such as meat or milk, and determine molecular residuals with excellent precision and extremely low limits of detection. Connect with an expert today.

       

      Your partner for clearance assays and toxicology testing

      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.

      Our 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 us 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.

      Unsurpassed Regulatory

      Given the sophistication of today’s pharmaceuticals and the complexity of the development process, an analytical lab partner with broad technical expertise and a strong regulatory history/performance is more important than ever. In a recent Industry Standard Research (ISR) survey, respondents noted technical expertise and regulatory history/performance as the most important criteria for selecting an analytical lab.

      Bioanalysis (Nonclinical and Clinical)

      Our laboratory uses a wide range of techniques and technology platforms to meet the needs of our customers, and more in support of PK/TK, pharmacology, bioequivalence and bioavailability studies, and biomarker assays from early discovery to post marketing. Bioanalysis is somewhat unique in that it is required for the evaluation of a therapeutic throughout the entire drug development cycle.

      Ready to Get Started?

      Give us a call and speak with an actual scientist.

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