CO.DON built one of the world’s largest and most modern GMP facilities for the production of personalized cell therapies on an industrial scale for in-house and contract manufacturing.
In less than one year.
Read this case study to discover what solutions made it possible.
CO.DON AG is a biopharmaceutical company that develops, produces, and distributes autologous cell therapies for the treatment of articular cartilage defects. CO.DON was established in 1993 and is based in Germany.
CO.DON’s Spherox is the only available Advanced Therapy Medicinal Product (ATMP) for cartilage repair with EMA approval. It was developed under isolation technology since the beginning of the nineties.
After receiving EMA product approval in 2017, the isolator with integrated incubation approach began to show its limits, given the foreseen increase in production requirements. Fully loaded, integrated incubators meant the isolator was at a dead end. In case of any technical issues with the isolators or incubators, the cells could not be transferred to another system.
These limits brought CO.DON to dream of a new site to handle production expansion while improving flexibility, traceability, and commercial sustainability.
“How do we increase and maximize cell production capacity while keeping or improving the quality standards, allow for best product management and contain the production costs for an optimal cost-efficiency ratio?”
A new manufacturing facility serving 4500 patient batches per year, with the ability to offer:
- 18.000+ days of quarantine for the biopsies coming from the surgical suite (4500 patient samples x 4 days of quarantine each)
- 72.000+ IN/OUT operations for cell checks and media changes (each patient’s cells require a total of 16 handing steps)
- 229.000+ days of total incubation time!
As additional constraints, the space available was limited (a total of 300 sqm for the laboratory area) and the request to keep the lowest possible environmental classification was a must.
CO.DON approached Comecer, as at that time they had just announced their new MCCI and FlexycultTM systems.
Comecer then developed with CO.DON a customized, turnkey solution addressing the requested requirements (URS) using these two systems.
Modular Cell Culture Isolator: a Comecer isolator integrated with all the necessary equipment to perform Cell Therapy processing (incubator, centrifuge, refrigerator, freezer, microscope, and more).
Flexycult: a flexible, docking incubation system running under grade A, with a sterile interface to the isolator and docked into a separate, upgradable ground base where all the utilities are managed.
The automatic incubator module transportation (from docking station to isolator) is controlled by a robotic system and dedicated software (Flexycult Management System – FMS).
The system is completed by interactive communication among modules, isolators, and operators, automatic tracking, and full SOP assistance for the operators.
Only 11 months after the contract was signed, on schedule and within budget, Comecer delivered all the equipment, assembled it in the new facility and then carried out an intensive validation and qualification process.
The new CO.DON facility is operational and fully authorized under a German BLA for internal and contract manufacturing cell production, since January 2020.
“When you can touch the equipment and see how it was built – from the design through to assembly and installation on site – it really gives you a thrill.”
Dr Andreas Eberle, Vice President Technical Operations, CO.DON AG, about the installation of the plant
The CO.DON project and other cell and gene therapy references are detailed in Comecer’s ATMP/C> Catalogue. We invite you to take a look.
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