Pharmaceutical, Biopharmaceutical, & Animal Health

Biopharmaceutical Testing Services

Virology

  • Viral clearance study
  • Adventitious virus testing
  • 9CFR virus detection for animal products
  • Transmissible spongiform encephalopathy (TSE)-clearance study
  • Facility cleaning/disinfection validation targeting viruses

Microbiology

  • Mycoplasma contamination test
  • Mycoplasma-clearance study
  • Facility cleaning/disinfection validation targeting microbes
  • Microbial isolate identification

Molecular Biology

  • Residual DNA test
  • DNA-clearance study
  • Next-generation sequencing

In-vitro Toxicology

  • Bovine Corneal Opacity and Permeability (BCOP) per OECD 437
  • EpiOcular® Eye Irritation (EO)
  • Cytosensor Microphysiometer (CM)
  • Agar Overlay Cytotoxicity Assay per ISO 10993-5
  • Direct Cell Contact Cytotoxicity Assay per ISO 10993-5
  • MEM Elution Cytotoxicity Assay per ISO 10993-5
  • MTT Cytotoxicity Assay per ISO 10993-5
  • Neutral Red Uptake Cytotoxicity Assay per ISO 10993-5

 

  • Phototoxicity in 3T3 cells and 3-D Tissues per OECD 460
  • EpiDerm®Skin Irritation Test (SIT) per OECD 439
  • EpiDerm®Skin Corrosion Test (SCT) per OECD 431
  • Corrositex & Skin Corrosion (EpiDerm®) per OECD 435
  • Acute Systemic Toxicity (3T3 Neutral Red Uptake) per OECD 129

 

  • Ames Test per ISO 10993-3 / OECD 471
  • In-Vitro Mouse Lymphoma Assay per ISO 10993-3 / OECD 476
  • In-Vitro Micronucleus Assay per ISO 10993-3 / OECD 487
  • Chromosome Aberration Assay per ISO 10993-3 / OECD 473