This page contains specialised information intended exclusively for licensed medical professionals. By continuing, you confirm that you are a physician or medical care provider.
Personalised Cell Production
With both Injectable MACT (Matrix-Associated Autologous Chondrocyte Transplantation) and MACT, the production of high‑quality chondrocytes is a prerequisite for favourable clinical outcomes. Behind each implant lies a multi-week process of careful culture, testing, and release—requiring trained personnel and sustained oversight at every stage.
Designed for Sterility
At the TETEC manufacturing site in Reutlingen, Germany, every stage takes place inside a closed isolator system—sealed from the environment, nested within a GMP-certified cleanroom. Materials and tools enter through hydrogen peroxide–sterilized airlocks. Pressure zoning and HEPA-filtered airflow enforce full microbial segregation.
.png)
.png)
.jpg)
Inside the Isolator
Within our isolator system, cell manufacturing relies on human precision. Explore how controlled handling and environmental discipline protect the integrity of every implant.
Highly trained cell technicians—operating entirely via glove ports—oversee each patient’s cells during a culturing process that lasts approximately 21 days. Tasks like plating, feeding, centrifugation, and sampling are performed manually. Records are kept under strict GMP procedures.
Culture conditions are controlled to approximate joint physiology: exact temperature, humidity, CO₂. At defined checkpoints, qPCR (quantitative Polymerase Chain Reaction), viability assays, and sterility tests are run. If any test fails, the graft is not released for use.
Each tissue graft is prepared by specialists for a single patient—reducing the risk of cross-contamination.
Precise and Patient-Specific
Currently, production is carried out manually as individualized biologic reconstruction in Reutlingen, Germany.
Looking ahead, TETEC is developing automated solutions with the goal of supporting scalability while upholding regulatory and quality requirements.
The Future Is Scalable
In 2024, TETEC joined Octane Medical Group. As part of this integration, we’re expanding our manufacturing capabilities with the planned introduction of the Octane Cocoon® bioreactor—a fully automated, closed-system platform for cell therapy production. Learn more about our work with Octane and our shared commitment to scalable, high-quality therapies.
Quality Assurance
Our autologous chondrocyte therapies are manufactured under standards for precision, quality, and regulatory compliance. Review the manufacturing controls and supporting data behind the quality and safety of Injectable MACT.
Manufactured in cleanrooms under Paul-Ehrlich-Institut (PEI) oversight [1].
Each implant is released with validated sterility, cell vitality, and gene expression analysis.
Including qPCR (quantitative Polymerase Chain Reaction) confirmation of cartilage-specific markers [1].
Cultured without antimicrobials or transgenic engineering [1].
Hydrogel biomaterials support redifferentiation and help maintain cartilage-specific morphology [2].
Independent studies confirm excellent chondrocyte distribution and matrix behaviour in vitro and in vivo [3].
Manufacturing and release are carried out under the EU-ATMP framework with National Competent Authority Paul-Ehrlich-Institut (PEI) oversight.
Why TETEC?
Contact TETEC
1. TETEC AG. Fachinformation NOVOCART Inject. Reutlingen (DE): TETEC AG; 2022. Stand der Information: 12/2022. PEI.A.11763.01.1.
2. Niemeyer P, Hanus M, Belickas J, László T, Gudas R, Fiodorovas M, et al. Treatment of large cartilage defects in the knee by hydrogel-based autologous chondrocyte implantation: two-year results of a prospective, multicenter, single-arm phase III trial. Cartilage. 2022;13(1):19476035221085146. doi:10.1177/19476035221085146.
3. Nuernberger S, Cyran N, Albrecht C, et al. Influence of scaffold architecture on chondrocyte distribution and behaviour in matrix-associated chondrocyte transplantation grafts. Biomaterials. 2011;32(4):1032–1040. doi:10.1016/j.biomaterials.2010.08.100.