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GeneFab – Your ready-to-configure ATMP-facility

The demand for approved therapy medicinal products is increasing day by day. Unfortunately, we find that their production remains limited because production facilities for this new form of medicine are a lot more strictly regulated than those of traditional GMP biologics. Many start-ups and even established producers within pharma are looking for a solution to this problem. Because, like us, they recognise that this new type of medication has the potential to fulfil unmet medical needs in the future.

ATMP-production comes with challenges

Converting a medical manufacturing facility to an ATMP facility requires numerous modifications. Not only in terms of production processes, but also the logistics process behind it requires much more accuracy. Every part of the production process affects the quality of the final product. The difficulty, and also the strength of ATMP medicines, is that each final product is linked to a specific patient. Given that each autologous ATMP batch yields one dose for one patient, expanding production is not a question of boosting volume, but rather of amplifying single manufacturing runs.

Expanding the production of ATMPs to serve more patients brings several challenges. Besides the fact that every manufacturing facility must accommodate patient-specific production, there are other challenges like the requirement of QC release testing and the establishment of a chain of custody for transferring individual doses. Since cell-based products have short self-lives, there may be no delays or congestion during the process. External conditions of the production and testing process should also be determined. By defining the starting materials and raw materials in advance, critical material attributes and critical quality attributes (CQAs) can be established to fulfil requirements of the quality by design methodology.

The amount of equipment necessary to produce commercial volumes of ATMPs is generally high. It is crucial to design an efficient room layout so as not to create an oversized space that is costly to condition and operate due simply to the volume of the space. Conversely, undersizing the space results in cramped working conditions. Advanced Therapy Medicinal Product production are often carried-out within Grade A biosafety cabinets with a Grade B background or within isolators. These pieces of equipment also occupy a relatively large footprint within the production suite. It is important to provide proper operating clearances while also accommodating the flow of materials and operators through the production suite in a way that will not adversely affect the use of the equipment or the quality of the environment.

Ready-to-use ATMP facility for indoor or outdoor use

With GeneFab, ABN Cleanroom Technology introduces a ready-to-use Cell & Gene Therapy facility for large-scale ATMP production. The facility can be placed indoor or outdoor and has been developed with a pre-engineered design taking into account all the challenges that ATMP production entails. Thanks to the insulated plenum under the ceiling, the production process is always protected from possible decontamination. The production facility is equipped with a GMP-validated IoT cloud Platform (GMP Connect), digitising the validation processes in collaboration with our strategic partner MyCellHub.

1. Produktion außerhalb des Standorts, Montage vor Ort

Legalisierung bedeutet Standardisierung. Die Standardisierung führt zu einer Verlagerung der Produktion. Die Arbeiten werden in klimatisierten Räumen wie Fabrikhallen durchgeführt. Unsere Reinräume werden teilweise oder vollständig außerhalb des Standorts hergestellt, was enorme Einsparungen bei den Transportkosten und weniger Unannehmlichkeiten vor Ort bedeutet