KCAS Bio Lyon Site Achieves Level A GLP Compliance Renewal, Strengthening IND-Enabling Study Support
核心洞察
KCAS Bio (搜索)'s Lyon, France facility successfully renewed its Good Laboratory Practices (GLP) compliance statement with Level A status according to Directive 2004/9/CE for safety tests.
The renewal reinforces the site's capability to support critical investigational new drug (搜索) (IND)-enabling programs with regulatory-ready bioanalytical data.
The facility maintains ISO 9001:2015 certification for over 15 years and provides toxicokinetic studies across multiple preclinical species and therapeutic modalities.
KCAS Bio (搜索) announced that its European facility in Lyon, France, has successfully renewed its Statement of Compliance with Good Laboratory Practices (GLP) according to Directive 2004/9/CE for safety tests, maintaining its ability to deliver GLP-grade bioanalytical methods for preclinical studies. The facility achieved Level A compliance status, the highest rating available.
Regulatory Milestone Reinforces IND Support Capabilities
The GLP test facility's Level A compliance renewal strengthens KCAS Bio (搜索)'s capability to support critical investigational new drug (搜索) (IND)-enabling programs. This achievement provides drug development sponsors with continued confidence that their studies are backed by robust, compliant, and regulatory-ready bioanalytical data essential for advancing therapeutic candidates through the development pipeline.
The renewal complements the site's ISO 9001:2015 certification, which has been maintained without interruption for more than 15 years. This dual certification framework reflects the rigor, reliability, and consistency demonstrated by the scientific teams at the Lyon facility across all projects throughout the drug discovery and development continuum.
Scientific Excellence and Quality Assurance
"Our renewed GLP compliance underscores our unwavering commitment to scientific excellence and regulatory integrity," said Dr. Mouhssin Oufir, KCAS Bio (搜索) – Lyon General Manager and GLP Test Facility Manager. "For drug development sponsors advancing IND-enabling programs, the quality and credibility of bioanalytical data are critical. Achieving and maintaining a Level 'A' compliance status demonstrates that our systems, processes, and people are aligned to deliver the dependable, regulatory-ready data sponsors need to move forward with confidence."
Comprehensive Preclinical Testing Capabilities
The Lyon site supports Toxicokinetic (TK) studies across an extensive range of preclinical species, including mouse, rat, rabbit, dog, minipig, and non-human primates such as marmoset and cynomolgus monkey. The facility provides specialized bioanalytical expertise across multiple therapeutic modalities, encompassing large molecules (搜索), biologics (搜索), small molecules (搜索), cell and gene therapies (搜索), vaccines (搜索), and oligonucleotides.
Through its sustained commitment to quality and compliance standards, KCAS Bio (搜索) enables pharmaceutical sponsors to generate reliable data that supports informed decision-making throughout both preclinical and clinical development phases. The company operates as a premier international provider of bioanalytical and laboratory services, offering comprehensive GLP- and GCP-compliant development services from early discovery support through commercial approval and beyond.