Cell Culture Isolators and FlexycultTM Incubation System for Advanced Therapy Labs
CO.DON AG Leipzig, Germany
Spherox is the only available Advanced Therapy Medicinal Product (ATMP) for cartilage repair with EMA approval. Approved in EU for indication knee (femur, patella), it has been developed under isolation technology since the beginning in the nineties. This pioneering vision has been challenged again after EMA approval: the foreseen increase of production requirements (flexibility, traceability, sustainability) concerned with the expected increasing demand, forced the company to look to a new approach, while not changing significantly the process features. So the question was: “How do we increase and maximize 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?”.
The new plant for the production of the autologous personalized cartilage repair drug needs to serve approximately 4500 patient kits per year.
Translated in process actions, this means 18.000+ days of quarantine for the biopsies coming from the surgical theatre, 72.000+ IN/OUT operations for checks and media changes, 220.000+ days of incubation time. On the other hand, to contain costs, the space available was limited (300 sqm for the laboratory area in total) and the request to keep the lowest possible environmental classification was a must. These tight constraints suggested that a change in the approach was needed, as well as the development of an innovative space management concept and the introduction of a degree of automation for simplifying and making robust the procedural approach.
3 Isolators and 144 mobile incubators
Modular Cell Therapy Isolator is a Comecer concept describing an Isolator integrated with all the necessary equipment to perform Cell Therapy processing (incubator, centrifuge, refrigerator, freezer and more). Moreover, a FlexycultTM mobile incubation system completes the available basic equipment. FlexycultTM is an incubator running under grade A, with a sterile interface to Isolator Systems and docked into a ground base where all the utilities are managed.
The plant is composed of 3 isolators units, as described above, in Grade D and 144 FlexycultTM incubators in 16 docking stations, with automatic module transportation controlled by dedicated software (FlexycultTM Management System – FMS), interactive communication among modules, isolators and operators, automatic tracking and full SOP assistance for the operators.