Spotlight On Excell-Ence: Quality Assurance Team

The Quality Assurance (QA) function at a cell therapy Contract Development and Manufacturing Organization (CDMO) is essential for maintaining product safety, efficacy, and regulatory compliance. At Excellos, QA and Regulatory teams ensure that development and manufacturing processes align with current Good Manufacturing Practice (cGMP) and Good Tissue Practice (GTP) standards. Their responsibilities include oversight of standardized procedures, control measures, documentation, and quality systems that support consistent and reproducible outcomes.

The Quality Management System (QMS) at Excellos is designed to be adaptable, risk-based, and aligned with both regulatory requirements and organizational objectives. It is reviewed regularly to support ongoing improvements. Following a comprehensive transition from the San Diego Blood Bank’s quality infrastructure, the QMS now encompasses QA Operations, Compliance, and Quality Control functions. These teams collectively support daily operations, manage audits and inspections, and oversee product testing and release, forming a structured and responsive approach to quality within the cell therapy manufacturing environment.