Advanced In Vitro Assay Services
LifeNet Health LifeSciences offers in vitro assay services, under the direction of industry leader James McKim, PhD, DABT, following the acquisition of IONTOX. We are dedicated to improving alternative methods for predicting adverse effects from drug or chemical exposure. We deliver high quality data combined with scientific expertise and innovation to accelerate the progress of your pipeline and to provide you with the answers to your most complex toxicological and product safety questions.
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Biocompatibility & Genotoxicity Assays
Evaluate medical device safety through our in vitro assay offerings, which meet ISO 10993 and OECD guidelines. We offer expert regulatory guidance. Learn more.
Cytotoxicity Assays
Our carefully designed in vitro cytotoxicity tests and screening models help determine drug or chemical cell toxicity – greatly improving the success of New Chemical Entities. Learn more.
DMPK/ADMET
In vitro DMPK/ADMET assays profile the pharmacokinetic properties of a drug candidate, including compound absorption, metabolic stability, protein binding, distribution, and drug-drug interactions. Learn more.
New Approach Methodologies
Get superior, human-relevant data – without in vivo testing – through innovative testing platforms. Learn more.
Epithelial Irritation & Toxicity
Our in vitro toxicological assessments examine cytotoxicity and additional endpoints on various epithelial tissues. Learn more.
Dermal Services
Assess irritation, corrosion, and induction of hypersensitivity to the skin through potency assessments and GHS hazard evaluations, which follow OECD guidelines. Learn more.
Ocular Services
Predict GHS hazard classification and irritation potency to provide a quantitative assessment of potential irritation to the ocular epithelium. Learn more.
Endocrine Disruption
Evaluate potential disruption of the endocrine system, including assays with our 3D Thyroid Microtissue model for TDCs. Learn more.
What Sets Us Apart
Our highly experienced in vitro assay services team offers a range of standardized and customized protocols. We provide study designs suitable for IND and regulatory submissions and collaborate with you to tailor the study to your specific research needs. We offer:
- Unsurpassed expertise ensures studies address your research questions and conforms to regulatory requirements
- Access to exclusive LifeNet Health innovation and the highest performing cells and biospecimens allow you to be at the forefront of research
- Quick turnaround speed ensures your milestones are met with quality non-GLP and GLP results to reports within 10 days for non-GLP and 25 days for GLP
Our Testing Process
Consultation
We take a partnership approach, which begins by working closely with you to identify your unique testing needs. Our team of experts then design a study plan to achieve your desired outcomes – with a focus on regulatory requirements.
Assay Development
We develop and validate your assay using many different cell models, with an emphasis on all-human primary cells and biospecimens to simulate in vivo conditions, which provides more relevant, reliable results than traditional testing methods.
Data Analysis
Our team of skilled scientists carefully analyze the data to determine a toxicity or safety profile. Our partnership continues through this stage, with the possibility of providing adaptable options as needed based on early results.
Results Review
We provide clear, concise reports that outline methods used, results and their significance – bringing simplicity to your biggest data challenges.