The Importance of Toxicology Studies in Drug Development

A substantial level of attrition for drug candidates is generally due to various toxicities and leads to high development costs, especially when not recognized until late in clinical trials. There is a great need for more useful biomarkers and short-term predictive assays for use in early drug discovery and development.

Understanding the absorption, distribution, metabolism, excretion (ADME), and toxicity (ADME-Tox) of new drugs is a key element of drug discovery. These studies provide insights into the disposition of a pharmaceutical compound in the body, including its safety and efficacy.

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Toxicology Studies in Drug Development

One of the key challenges with interpretation of toxicity studies in pre-clinical drug development is identifying the appropriate models that can provide clinically relevant results. While animal models remain one of the most important tools in preclinical toxicity studies, in vitro systems such as culturing primary human cells are becoming increasingly important for decision making in the drug development pipeline.

As a solution partner in toxicology, Lonza has robust portfolios in hepatoxicity, nephrotoxicity, respiratory toxicity, dermal toxicity and neurotoxicity.

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Lonza toxicology products

Pharmacokinetics and bioactivation

Cell type	Description	Catalog number
Liver cells	Human Hepatocytes, General Purpose	HUCPG
	Human Hepatocytes, Interaction Qualified	HUCPI
	Human Hepatocytes, Suspension Single Donor	HUCSD
	DonorPlex™ Human Hepatocytes, Suspension 10 Donors	HUCS10P
	DonorPlex™ Human Hepatocytes, Suspension 20 Donors	HUCS20P
	DonorPlex™ Human Hepatocytes, Suspension 10 Donors, Female	HUCS10PF
	DonorPlex™ Human Hepatocytes, Suspension 10 Donors, Male	HUCS10PM
	DonorPlex™ Human Hepatocytes, Suspension 20 Donors, Female	HUCS20PF
	DonorPlex™ Human Hepatocytes, Suspension 20 Donors, Male	HUCS20PM
	DonorPlex™ Human Hepatocytes, Suspension 50 Donors	HUCS50P
Hepatocyte cell lines	NoSpin HepaRG® Cells	NSHPRG
Kidney cells	Human Cortical Epithelial Cells	CC-2554
	Human Renal Epithelial Cells	CC-2556
	Human Renal Proximal Tubule Epithelial Cells (RPTEC)	CC-2553

Absorption Modeling

Cell type	Description	Catalog number
Lung cells	SAEC - Human Small Airway Epithelial Cells	CC-2547
	Human Bronchial/Tracheal Epithelial Cells with Retinoic Acid	CC-2540
	Human Bronchial/Tracheal Epithelial Cells without Retinoic Acid	CC-2541
Skin cells	Adult Human Dermal Fibroblasts	CC-2511
	Neonatal Human Dermal Fibroblast	CC-2509
	Neonatal Human Epidermal Keratinocytes, Pooled	00192906
	Neonatal Human Keratinocytes, Single Donor	00192907
	Adult Human Epidermal Keratinocyte, Single Donor	00192627

Mechanistic Toxicity

Cell Type	Description	Catalog Number
Nervous System Cells	Mouse CD1 Brain Hippocampus Neurons	R-CX-500
	Mouse C57 Brain Cortex Neurons	M-CX-400
	Mouse CD1 Brain Cortex Neurons	M-CX-300
	Rat Brain Cortex Neurons	R-HI-501
	Rat Brain Hippocampus Neurons	M-HI-401
	Rat Microglia	R-G-535
Liver Cells	Human Hepatocytes, General Purpose	HUCPG
	Human Hepatocytes, Interaction Qualified	HUCPI
	Human Hepatocytes, Suspension Single Donor	HUCSD
	DonorPlex™ Human Hepatocytes, Suspension 10 Donors	HUCS10P
	DonorPlex™ Human Hepatocytes, Suspension 20 Donors	HUCS20P
	Human Liver Non-Parenchymal Cells	HUCNP
	Human Stellate Cells, 0.2 mio cells	HUCLS-200K
	Human Stellate Cells, 1 mio cells	HUCLS-1M
	Human Kupffer Cells, 0.2 mio cells	HLKC-200K
	Human Kupffer Cells, 0.5 mio cells	HLKC-500K
	Human Liver-Derived Endothelial Cells	HLECP1
Kidney Cells	Human Cortical Epithelial Cells	CC-2554
	Human Renal Epithelial Cells	CC-2556
	Human Renal Proximal Tubule Epithelial Cells (RPTEC)	CC-2553
Lung Cells	Human Bronchial/Tracheal Epithelial Cells with Retinoic Acid	CC-2540
	Human Bronchial/Tracheal Epithelial Cells without Retinoic Acid	CC-2541
	Human Small Airway Epithelial Cells	CC-2547
	Bronchial Smooth Muscle Cells	CC-2576
	Lung Microvascular Endothelial Cells	CC-2527
Skeletal Cells	Skeletal Muscle Myoblasts	CC-2580
Vascular	Aortic Endothelial Cells	CC-2535
	Aortic Smooth Muscle Cells	CC-2571
	Human Umbilical Vein Endothelial Cells, Single Donor	C2517A
	Human Umbilical Vein Endothelial Cells, Pooled	C2519A