Lykan’s Quality Management System (QMS) and Quality Control (QC) programs have been developed to ensure product quality while offering the flexibility needed to support manufacturing for all phases of development and commercialization. Our QMS is ICH-compliant and managed by a team with significant PAI and routine cGMP inspection experience. Designed to include client collaboration, review, and approval, we offer:
- Quality agreements
- Client Disposition Package
- Client approvals of project-specific cGMP documentation
- Regulatory inspection support
- Client audits
- Person-in-Plant (PIP) program
Our experienced Quality Assurance (QA) team is integrated with the facility and manufacturing teams and the QMS is part of Lykan’s paperless environment. This real-time access to the facility, production and testing gives full transparency to QA which allows for close oversight, review of processes and issue resolution.
The QC team maintains a close partnership with our Manufacturing Science and Technology team for method transfer, optimization, qualification, and validation. Our comprehensive QC laboratories are located directly adjacent to manufacturing for rapid deployment of cGMP testing. Capabilities include:
- Core cell therapy methods including: qPCR, rapid micro methods, flow cytometry, ELISA, automated cell counting
- Incoming raw material, in-process and final product testing
- Network of qualified contract testing laboratories to supplement in-house
capability for USP Sterility and other methods, as required
- Environmental, personnel, and utility monitoring