Certified Quality and Controlled Manufacturing for Research Biomaterials

At Metatissue, we operate in a highly quality-sensitive environment where product reliability and compliance directly impact on our customers’ research outcomes. By maintaining a Quality Management System (QMS) certified according to ISO 9001 for the Research, Development, and Manufacturing of human protein-based products, we demonstrate an unwavering commitment to customer satisfaction and a quality-focused culture oriented towards continuous improvement, innovation and new value creation.

ISO 9001 certification is more than a standard; it is a framework that translates into:

• Enhanced Reproducibility: Documented and repeatable R&D and manufacturing workflows ensure consistent batch quality.
• Data Integrity: Controlled documentation and rigorous record-keeping ensure the validity and traceability of all experimental and production data.
• Minimized Variability: Standardized procedures leads to batch-to-batch consistency across production batches, which is essential for successful 3D cell culture and other advanced applications.

Rigorous Operational Control
All operational procedures are clearly defined by SOP (Standard Operating Procedures). This structured approach ensures that every step of our process is geared toward maintaining the highest product standards.

Product Excellence and Characterization
Our products are thoroughly characterized according to Critical Quality Attributes (CQA). Written established test methods and specifications are applied to evaluate essential parameters, including Ability to form a gel, Degree of methacrylation, Biological safety (Endotoxin, Sterility, Mycoplasma), Cell viability and Mechanical properties.

Furthermore, stability studies determine the shelf life and storage conditions necessary to maintain the safety, purity, and potency of our products over time.

Guaranteed Quality Assurance
To protect the integrity of our partners’ work, no batch is released for sale or supply until it has been certified by our Quality Department. Every batch is verified against its specifications and accompanied by a Certificate of Analysis (CoA), providing our customers with the reassurance that Metatissue is dedicated to a culture of innovation, reliability, and new value creation.

See our ISO 9001:2015 certificate