KCAS Bio’s Lyon Site Renews GLP Compliance, Strengthening Support for IND-Enabling Studies
KCAS Bio has announced that its European bioanalytical facility in Lyon has successfully renewed its Statement of Compliance with Good Laboratory Practices (GLP). The renewal was granted in accordance with Directive 2004/9/EC for safety testing, confirming that the site continues to meet strict regulatory standards for conducting high-quality bioanalytical work in support of preclinical research.
The renewal affirms the facility’s capability to deliver GLP-compliant bioanalytical methods that are essential for early-stage drug development programs, particularly those designed to support investigational new drug (IND) submissions. Maintaining this certification ensures that the Lyon site remains fully qualified to generate reliable, regulatory-grade data that pharmaceutical and biotechnology sponsors require when preparing safety and efficacy documentation for regulatory authorities.
During the recent evaluation process, the Lyon facility once again achieved a Level “A” compliance rating, the highest level of compliance awarded under GLP inspection frameworks. This rating reflects the site’s strong adherence to regulatory requirements, robust operational systems, and well-documented scientific procedures. By maintaining this level of compliance, KCAS Bio continues to demonstrate its readiness to support critical IND-enabling studies that form the foundation of new therapeutic development.
For sponsors engaged in early drug development, the reliability of bioanalytical data plays a crucial role in regulatory decision-making. GLP-certified testing environments ensure that the methods used to measure drug concentration, metabolism, and biological effects are consistent, validated, and fully traceable. With its renewed GLP compliance, the Lyon facility provides sponsors with confidence that their studies are conducted within a framework that meets internationally recognized regulatory expectations.
The site’s GLP certification is complemented by another key quality credential: its long-standing ISO 9001:2015 certification. The Lyon facility has maintained this certification for more than 15 consecutive years, demonstrating an enduring commitment to quality management, continuous improvement, and operational excellence. Together, these two certifications underscore the laboratory’s dedication to maintaining rigorous scientific standards across all stages of the drug discovery and development process.
According to leadership at the Lyon site, the renewal highlights the commitment of the facility’s scientific teams to maintaining the highest standards of regulatory compliance and scientific integrity. The teams operate within carefully structured processes designed to ensure that every aspect of study design, method development, validation, and data analysis meets strict regulatory requirements.
Dr. Mouhssin Oufir, General Manager and GLP Test Facility Manager for KCAS Bio in Lyon, emphasized the importance of maintaining these standards for companies working to advance new therapies. He noted that achieving and sustaining a Level “A” GLP compliance rating reflects the organization’s ongoing commitment to quality and regulatory reliability. For pharmaceutical sponsors preparing IND-enabling programs, the credibility and accuracy of bioanalytical data are critical components of the development process. High-quality data ensures that developers can confidently move forward with regulatory submissions and subsequent clinical phases.
Dr. Oufir also highlighted that maintaining GLP compliance involves continuous effort across the entire organization. From laboratory procedures and quality assurance systems to staff training and equipment calibration, every component of the facility’s operations must consistently meet the requirements outlined by regulatory authorities. This coordinated approach helps ensure that the Lyon site delivers dependable results that align with international regulatory expectations.
The KCAS Bio Lyon facility plays an important role in supporting toxicokinetic (TK) studies across a wide range of preclinical animal models. These studies help researchers understand how investigational drugs are absorbed, distributed, metabolized, and eliminated in the body. Such information is essential for determining safe dosage levels and assessing potential toxicity before human clinical trials begin.
To support these studies, the Lyon laboratory works with numerous preclinical species commonly used in regulatory toxicology research. These include mice, rats, rabbits, dogs, and minipigs, as well as non-human primates such as marmosets and cynomolgus monkeys. By supporting studies across multiple species, the facility enables sponsors to gather comprehensive pharmacokinetic and toxicokinetic data required for regulatory submissions.
Beyond its work in toxicokinetics, the Lyon site provides specialized bioanalytical expertise across a wide range of therapeutic modalities. The laboratory supports programs involving small molecules and large-molecule biologics, as well as emerging technologies such as cell and gene therapies. It also has capabilities in analyzing vaccines and oligonucleotide-based therapeutics, which are becoming increasingly important in modern drug development.
These capabilities allow KCAS Bio to assist sponsors at multiple stages of the drug development lifecycle. From early discovery through preclinical testing and into clinical development, the laboratory provides analytical support that helps ensure the accuracy and reliability of critical scientific data. This comprehensive approach enables pharmaceutical and biotechnology companies to make well-informed decisions as they advance new therapies toward regulatory approval.
By maintaining strong quality systems and continuously meeting GLP and ISO standards, KCAS Bio aims to provide a dependable foundation for the development of innovative medicines. Reliable bioanalytical data not only supports regulatory submissions but also helps guide key strategic decisions during the development process.
With the renewal of its GLP compliance statement, the Lyon facility reinforces its role as a trusted partner for drug development sponsors worldwide. The achievement highlights the laboratory’s ability to deliver consistent, regulatory-ready data while supporting the complex scientific requirements of modern therapeutic development. Through its continued dedication to quality, compliance, and scientific rigor, KCAS Bio helps ensure that sponsors can confidently progress their research programs from preclinical evaluation to clinical advancement.
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