Erkrath, Germany

Background

• Founded in 1993 as NewLab BioQuality
• Acquired by Charles River in 2008

Staff

• 235 employees, approximately 40% with advanced degrees (MS, PhD)

Laboratories and Facilities

• 6,900 meters²/74,270 feet²
• Biosafety level 2 laboratories

• Testing Services
  • Cell line characterization and bulk harvest testing
  • Biosafety testing of biologics and raw materials
  • Cell-based bioassays (mode of action and potency)
  • Protein and analytical chemistry
  • Host cell protein determination
  • Lot and drug product release testing
  • Process characterization (resin cycling)
  • DNA sequencing
  • CO1 Barcode Assay for cell line identity
  • Residual DNA determination
  • Virus detection by PCR
  • DOE (Design of Experiment)
  • Mycoplasma testing (culture and PCR)
  • Sterility testing
  • Retrovirus tests
  • Replication-competent retroviral vector tests
  • Mass Spectrometry
  • Transmission electron microscopy via partnership with ATEM Structural Discovery
  • Next Generation Sequencing (NGS) via partnership with PathoQuest
  • Custom method development
  • Method transfer and validation
  • Genetic testing

Our biologics testing services are relevant for quality control of:

• Recombinant proteins
• Monoclonal antibodies
• Viral vaccines
• Cell therapies
• Gene therapies
• Oncolytic viruses
• Blood products
• Life biopharmaceutic products
• Animal-derived raw materials
• Cultured meat