What We Can Do
Our Quality Management System (QMS) and Quality Control (QC) procedures have been developed to meet US and EU regulatory standards for cell therapy products while offering the flexibility required to support clinical and commercial manufacturing. Lykan’s Quality Team has:
- Robust and flexible cGMP compliance systems
- Successful history of hosting third-party audits
- Comprehensive QC analytical capabilities
Quality Management System
Our QMS is ICH-compliant and managed by a team with significant regulatory inspection experience, including FDA and EMA pre-approval inspections (PAI) in addition to general cGMP inspections.
Lykan’s Quality System is designed to accommodate partner input and involvement.
- Partner disposition package
- Partner approvals
- Partner audits
- Person-in-Plant (PIP) encouraged
- Quality agreement
- Regulatory inspection support
- Site Master File
Our experienced Quality Assurance (QA) team is integrated throughout the operation. This transparency to QA enables cGMP compliance and allows for rapid identification and resolution of issues as they arise.
The QC team maintains a close partnership with the Analytical Development team in support of method transfer, optimization, qualification, and validation.
Our QC laboratories are located adjacent to the manufacturing core to facilitate rapid transfer of product samples for analysis. Capabilities include:
- Testing of incoming raw materials, in-process and final product samples
- Core chemistry, analytical, and microbiological analysis (e.g., compendial analysis, ELISA, rapid sterility, microbial identification, spectroscopy)
- Stability studies, management of reference standards and controls, and facilitating outsourced characterization testing
- Environmental, personnel, and utility monitoring
Lykan’s team has decades of biotechnology industry experience with different platforms, tools, and technologies.
All quality team members were carefully selected and properly trained, resulting in a strong quality team that brings excellence and the highest quality standard to the development and manufacturing of cell-based therapies.
The QC Labs
Our comprehensive QC laboratories are located adjacent to manufacturing for rapid deployment of cGMP testing
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Lykan Bioscience is a premier provider of development and manufacturing services