Microbial Solutions Facility: Ecully, France

Site Background

• Amilabo began distributing Endosafe® in 1995
• They were acquired by Charles River in 1996
• Charles River acquires Accugenix® in 2012, launching microbial ID services at its French site
• In 2013, microbial solutions operations moved to the current Ecully site
• To date, the site hosts approximately 90 employees

Solutions and Support

• Accugenix^® microbial identification and strain typing services
• Celsis^® rapid microbial detection
• Endosafe^® bacterial endotoxin testing
• Customer service and laboratory technical support

Accreditation and Regulatory compliance

• ISO 9001 certification by AFAQ
• ISO 17025 accreditation by A2LA for Accugenix and Endosafe laboratories
• FDA cGMP compliance for Accugenix and 11737-3 certification (BET) for Endosafe lab
• Meets US FDA cGMP requirements; registered with the US FDA since 2009
• QUALIOPI certified

Quality and Process Initiatives

• Excellent regulatory compliance history
• Data integrity and paperless approach for Accugenix

Products and Services

• Contract endotoxin testing services (LAL assay)
• Use of the 3 USP and Ph. Eur. methods:
  • Gel-clot
  • Kinetic chromogenic
  • Kinetic turbidimetric
• FDA-licensed LAL cartridges
• Instruments:
  • Endosafe^® nexgen-PTS™, nexgen-MCS™, and Nexus™
• rCR: Recombinant Cascade Reagent
• Method development:
  • Product validation
  • Stability testing
  • Sample preparation
• Routine endotoxin determination (for routine and backup)
• Oven depyrogenation validation
• Material Depyrogenization
• LER study
• Training
• Microbial Identification Services:
  • Genotypic identification of bacteria, yeast, and fungi (rDNA sequencing)
  • Proteotypic identification of bacteria and yeast (MALDI-TOF backed by sequencing)
  • Protein-coding gene sequencing (DNA sequencing on different target genes)
  • Accugenix Environmental Monitoring Performance Qualification Services