Quality

Quality is every patient’s right and every employee’s responsibility. Quality provides a competitive advantage and is ingrained in Matica Biotechnology’s core principles, from concept through the final product. Our clients’ cell and gene therapy products touch human lives; therefore, quality is the true measure of our success.

Matica Bio’s Quality Management System (QMS) is designed to meet United States and international regulatory and statutory requirements for viral vector production and cell banking, as well as Matica Bio’s own commitment to the quality of the products produced at our facility in College Station, Texas.

Matica Bio has established and maintains written procedures for internal quality auditing to ensure all QMS elements are clearly defined, effectively followed and suitable for Matica Bio’s processes.

The Quality System is applicable throughout the product life cycle, including technical activities for clinical and commercial products.

Quality planning is necessary prior to taking on any project at Matica Bio. It is imperative that we assess each project’s fit for our facility by completing an initial project risk assessment. Once this assessment is completed and the decision is made to accept a project, Matica Bio will then initiate the project through technology transfer. Central to the successful execution of each client project is the development of a Quality Agreement to ensure we are all aligned in our quality expectations. This Quality Agreement will be a shared document that aligns the expectations of Matica Bio with those of our client.