Helping you move towards in vitro testing

For pharmaceutical developers and manufacturers, innovations in testing methodologies are driving a commitment to reduce or eliminate the need for in vivo testing. For many, identifying suitable alternatives, accessing specialised equipment, or aligning with complex regulatory frameworks presents a serious challenge. The Eurofins BioPharma Product Testing network of laboratories has decades of expertise and fully validated in vitro models, and supports manufacturers who are committed to ethical testing methods, without compromising regulatory compliance or data integrity. Our alternative toxicology services align with the principles of the 3Rs: replacement, reduction, and refinement. 

Our evaluation methods use a unique approach designed to improve the prediction of human results. We offer a comprehensive portfolio of services focused on replacing in vivo testing in areas such as acute systemic toxicity, skin and eye irritation, and skin allergenicity. Where full replacement is not yet feasible, we support the reduction of in vivo testing in repeated-dose toxicity, carcinogenicity, and reproductive toxicity studies. 

Using advanced techniques and state-of-the-art equipment, we work in close collaboration with independent scientists and regulatory agencies to ensure our methods meet evolving regulatory expectations. By actively partnering with researchers and clients in prevalidation and validation studies, we continue to drive the development and adoption of advanced techniques.

Study types for screening and regulatory purpose

 

in silico safety modeling

  • Structure activity relationship by computerised models

Eye irritancy

  • Bovine corneal opacity and permeability test (BCOP; OECD 437)
  • Hens egg chorionallantoic membrane test (HETCAM)
  • Reconstructed human corneal epithelial models (OCDE 492 and OCDE 492B)

Skin corrosivity

  • Reconstructed human skin equivalents (OECD 431)
  • Corrositex® Membrane barrier test (OECD 435)

Skin irritancy

  • Reconstructed human skin equivalents (OECD 439) Skin Sensitisation
  • in chemico: Direct peptide reactivity (OECD 442 C)
  • in vitro: KeratinoSens (OECD 442 D)
  • in vitro: Activity of dendritic cells – h-Clat

Systemic toxicity

  • Assessment of starting dose for acute systemic toxicity using neutral red uptake
  • Target organ toxicity with primary and cell lines from various organs
  • Phototoxicity – Balb/3T3 neutral red uptake with artificial UV-light (OECD 432)
  • Phototoxicity using human skin equivalents
  • Immunotoxicity: Lymphcyte blastogenesis, natural killer cell activity, macrophage function
  • Determination of cytokine release of peripheral blood mononuclear cells

Reproductive toxicity/endocrine sisruptor activity

  • Embryonic mouse stem cell test
  • Steroidogenesis assay using H295R cells (OECD 456)
  • Androgen receptor binding assay using cytosol of prostate (OPPTS 890.1150)
  • Estrogen receptor binding assay using cytosol of uteri (OPPTS 1250)
  • Aromatase assay using human supersomes (OPPTS 890.1200)
  • Transcriptional estrogen receptor binding assay using HeLa cells (OPPTS 890.1300)
  • Human skin equivalents (OECD 439)

Carcinogenicity

  • Cell transformation assays (Bhas 42) assay and syrian hamster embryo (SHE) assay

Toxicokinetics – barrier systems

  • Dermal penetration using flow-through diffusion cells and human and pig isolated skin systems
  • Intestinal uptake using CaCo-2 absorption models


Toxicokinetics – metabolism

  • Interspecies comparative metabolism, metabolic stability, metabolic profiling
  • Selective human cytochrome P450 metabolism
  • Human cytochrome P450 inhibition
  • MDR-(P-glycoprotein) interaction assay
  • Glucuronidation
  • Ethoxyresorufin-o-deethylase acitivty
  • Pentoxyresorufin-o-dealkylase activity
  • Benzyloxy-o-dealkylase activity

Local tolerance

  • Oral mucosal irritation using human reconstructed oral epithelium
  • Vaginal epithelial irritation using human reconstructed vaginal epithelium
  • Bladder epithelial irritation using human reconstructed bladder epithelium

Performance testing

  • Barrier efficacy test (human skin model)
  • Lenitive efficacy test (human skin model)
  • Wound healing efficacy (human skin model)
  • Whitening efficacy (human skin model)

Mechanistic investigations

  • Reactive oxygen species: catalase, glutathionperoxidase, glutathion, thiobarbituric acid reactive substances, superoxidedismutase
  • DNA adduct determination
  • Antikinetochore antibody staining (CREST) of micronuclei in mammalian cells