Innovative Breakthroughs in ADME Toxicology: Paving the Way for Safer Drug Development

Errol Byron — Mon, 14 Apr 2025 09:14:16 +0000

The field of ADME toxicology—Absorption, Distribution, Metabolism, and Excretion—continues to evolve with new technologies that enhance drug safety profiling and streamline pharmaceutical development. Here’s a look at the latest advancements that are driving innovation and improving accuracy in toxicological assessments.

1. Organ-on-a-Chip Technology Enhances Predictive Power

One of the most promising developments in ADME toxicology is the use of organ-on-a-chip (OOC) systems. These microfluidic cell culture devices simulate the physiological responses of human organs, providing more accurate data than traditional models. CN Bio’s recent launch of the PhysioMimix® DILI Assay Kit: Human 24 offers researchers a tool for more predictive drug-induced liver injury (DILI) studies in vitro.
Source: News Medical Life Sciences. “CN Bio Launches PhysioMimix® DILI Assay Kit.”

2. Growth in High-Throughput ADME Screening

High-throughput screening is now a cornerstone of early drug discovery. By allowing rapid, automated testing of thousands of compounds, this technology accelerates decision-making during candidate selection. Recent literature highlights how improved microscale assays are supporting faster and more reliable ADME profiling.
Source: Paine et al. (2020). “ADME and Bioavailability Studies in Drug Development: Current Methods and Future Directions.” Drug Metabolism and Disposition. Link

3. Machine Learning Boosts Predictive Accuracy

AI and machine learning (ML) models are increasingly used to predict ADME properties such as solubility, permeability, and metabolic pathways. One such model, FP-GNN (Fingerprint-based Graph Neural Network), has shown improved accuracy in predicting molecular properties related to ADME/tox profiles.
Source: Li et al. (2022). “FP-GNN: Molecular Property Prediction Using Fingerprint-based Graph Neural Networks.” arXiv preprint arXiv:2205.03834. Link

4. Expanding Market for ADME Toxicology Testing

The global ADME toxicology testing market is poised for strong growth, projected to reach USD 16.3 billion by 2030 with a CAGR of over 10%. This expansion reflects increased demand for high-quality safety and efficacy evaluations in drug development pipelines.
Source: Grand View Research. “ADME Toxicology Testing Market Size, Share & Trends Analysis Report, 2023–2030.”

5. Regulatory Advancements: ICH M12 Guideline

Regulatory harmonization is critical in the evaluation of drug interactions. The International Council for Harmonisation (ICH) has released the M12 guideline to unify approaches to drug-drug interaction studies, enhancing data consistency across regions.
Source: Admescope. “The ICH M12 Guideline on Drug-Drug Interactions.”

Conclusion

The integration of organ-on-a-chip systems, AI-driven models, and regulatory updates is shaping a new era in ADME toxicology. These innovations not only reduce drug development timelines but also improve the predictability of human responses to new compounds. For researchers and developers, staying informed about these advancements is essential for building safer, more effective therapeutics.

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Cell4Pharma Enters Distribution Agreement and Strategic Partnership with MatTek

Errol Byron — Wed, 23 Mar 2022 14:39:37 +0000

MatTek will act as a US-based distributor for Cell4Pharma’s ciPTEC renal cells, making them available to their broad customer base in the life sciences and diversifying their commercially available cell types. Cell4Pharma’s ciPTEC technology is a human renal cell line that mimics the proximal tubule of the kidney, a common target for drug-induced kidney injury. The cells are currently used by researchers in monolayer culture as a preclinical screening tool by pharmaceutical developers to evaluate potential negative impacts to the kidney.

MatTek’s goal is to create a more complex, 3-dimensional model of the human kidney to further enhance the in vitro capabilities and provide an even more accurate and predictive testing method for researchers within ADME tox market, estimated to be $6 billion USD according to ReportLinker. MatTek anticipates research and development to take 1 year and to have a finished product on the market within 18 months.

“MatTek has really pioneered the field of lab-grown tissues for preclinical testing, and we’ve had great success in developing multiple organ systems that have been shown to produce results much closer to live human responses than traditional animal testing,” said Kevin Causey, vice president of business development for MatTek. “We’ve already created a large selection of reliable lab-grown human skin, ocular, oral, airway, and digestive system tissues, and it’s a natural progression to move onto organs like the kidney to fill those gaps in available research systems.”

“The strategic partnership with MatTek is in line with our goal to accelerate our growing global network of strategic partners. This partnership supports our mission to support human-relevant research by providing synergistic life science products and services,” said Ron Byron, CEO of Cell4Pharma.

About MatTek

Founded in 1985, MatTek Life Sciences began producing three-dimensional human tissue models as reliable replacements for animal testing. MatTek’s physiologically advanced tissue models empower companies in the cosmetics, chemical, and pharmaceutical industries to achieve their goals of non-animal testing while lowering preclinical costs and providing human-relevant results. With locations in the US and Europe, today MatTek’s offerings include skin, eye, oral, respiratory, vaginal, and intestinal tissue models including disease modeling, validated, and custom testing services, multiple donor primary cells, culture media, and highly optical cultureware.

About BICO

Founded in 2016, BICO (formerly CELLINK) is the leading bio convergence company in the world. By combining different technologies, such as robotics, artificial intelligence, computer science, and 3D bioprinting with biology, we enable our customers to improve people’s health and lives for the better.

The company has a focus on developing technologies that will advance Health 4.0 Next Generation Core Industry Ecosystems that enable tissue engineering, diagnostics, multiomics, and cell line development. BICO’s technologies enable researchers in the life sciences to culture cells in 3D, perform high-throughput drug screening and print human tissues and organs for the medical, pharmaceutical, and cosmetic industries. We create the future of health.

The Group’s instruments in the field amounts to 25,000, including all the top 20 pharmaceutical companies, are being used in more than 65 countries, and have been cited in more than 9,500 publications. BICO is listed on Nasdaq Stockholm under BICO. www.bico.com

About Cell4Pharma

Cell4Pharma’s ciPTEC is a Dutch Bio- technology company, that developed a range of cell-based assays, including CiPTEC a human conditionally immortalized proximal tubular epithelial cell line, used for pre-clinical toxicology studies. Cell4Pharma envisions a world without a risk for renal toxicity for compounds entering clinical stages of drug development. Cell4Pharma aims to reduce the failure rate in late clinical stages due to renal tox below 3% market wide within the next 10 years. Without the use of animal experimentation.

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