In Vitro Alternatives

We offer a wide range of in vitro alternative methods to support and enable you to develop pharmaceutical products. We are driven by a focus on humanity–enhancing testing methods to ensure safer products and a safer world. Our comprehensive in vitro portfolio of local tolerance (irritation/corrosion) and sensitization assays can be used in an Integrated Approach for Testing and Assessment or Defined Approach.

In addition, we offer a suite of innovative ToxTracker® assays utilizing the novel GFP reporter systems. These systems reveal insightful mechanistic information into the genotoxic properties of compounds that goes beyond a “yes” or “no” answer. We also offer the Bhas 42 cell promoter transformation assay, a sensitive short-term system for predicting chemical carcinogenicity related to transformation promotion activity, which may be used as part of a testing strategy and/or in a weight of evidence approach for predicting carcinogenic potential.

Our scientists are at the cutting edge of in vitro alternative method development and are frequently requested to participate in regulatory working groups and testing/validation programs. With our over 25 years of experience in conducting regulatory accepted alternative methodologies, performing upwards of 200 GLP studies every year, you can enjoy the ease of working with an experienced partner providing insightful science tailored to meet your product and regulatory needs.

Local Tolerance

Skin irritation/corrosion

• In vitro skin corrosion (reconstructed human epidermis test method) EpiDerm™ 
• Corrositex™ (in vitro membrane barrier test method for skin corrosion) 
• In vitro skin irritation (reconstructed human epidermis test method) (EpiDerm™ SIT [EPI-200]) 

Eye irritation/corrosion

• Reconstructed human cornea-like epithelium test method for eye hazard identification 

Sensitization

• Direct peptide reactivity assay (DPRA) 
• Annex III - Kinetic direct peptide reactivity assay (kDPRA) 
• ARE-Nrf2 luciferase test method (KeratinoSens™) 
• Human cell line activation test (h-CLAT)

Cytotoxicity and phototoxicity

• ICH S10 - Phototoxicity (neutral red uptake [NRU] Balb/c 3T3) 
• ICCVAM (2006) - Cytotoxicity (NRU Balb 3T3 cells)
• Cytotoxicity (medical device testing)

Mechanistic/mode of action

• ToxTracker® 
• ToxTracker® AO (antioxidant) 
• ToxTracker® ACE (aneugen/clastogen evaluation)

Carcinogenesis

• Bhas-42 cell transformation assay

Click to access crop protection and chemical in vitro test methods.