Since recent breakthrough of ATMP technology, we are witnessing an increasing demand for cleanroom solutions and facilities. The specific needs for aseptic contained zoning are directly dependant to the phase of research. As we understand that ATMP research is offering ground-breaking new opportunities for the treatment of life-threatening diseases, we should not forget that the research & development is difficult and financially intensive with a substantial risk of discontinuation. In various ATMP applications, there are considerable logistical challenges when it comes to storing and transporting medicines that are based on vital cells. Looking back a few years ago, these products were made in the ordinary, traditional labs, but because of changes in regulations by the EMA, the production of ATMPs nowadays has to take place in a cleanroom environment that has the possibility to remain compliant with changing regulations in the future. The future of bioprocessing demands flexible and scalable solutions that can accommodate the rapidly evolving landscape of biopharmaceutical products while also minimizing the impact on the environment.
Misconceptions about ATMP
Where does ATMP stand in the current market of therapies? Due to the fact that there are many misconceptions about ATMP, we would like to shortly discuss the classification of ATMP and non ATMP treatment modalities. In order to do so, we refer to Karin Hoogendoorn MSc, as she has written an interesting overview with related directives about clarifying ATMP misconceptions.
Figure 1 - Source: Karin Hoogendoorn (2020). What are ATMPs: Clarifying misconceptions.
As the figure above shows, there are several types of technology or treatment modalities that Karin Hoogendoorn discusses, ranging by degree of complexity, from Chemicals to Tissue Therapy. Whereas Tissue Therapy, Cell Therapy and Gene Therapy are primarily considered to be ATMPs, treatment modalities such as Vaccines, Biotech and Chemicals are classified as non ATMPs. One of the most contemporary misconceptions about ATMP is that vaccines based on mRNA are considered to be a part of ATMP. However, as the figure of Karin Hoogendoorn shows, vaccines are not classified as ATMP’s. As mentioned, ATMPs can be classified into three main types. In addition, some ATMPs may contain one or more medical devices as an integral part of the medicine, which are referred to as combined ATMPs. An example of this is cells embedded in a biodegradable matrix or scaffold.
However, an important side note about this primary classification should be taken into account to avoid a first misconception. Within the Tissue Therapy and Cell Therapy treatment type, not every aspect is considered to be ATMP, but all Gene Therapies are ATMPs by EMA legal classification. To give a practical example: when Tissue Therapy deals with lab grown skin for burn treatment, it is classified
as ATMP. The skin transplant for burn treatment itself however is not considered to be an ATMP. This means, for example, that cells for transplant require to be prepared in the same manner as sterile dosage forms. Laboratories that want to produce ATMPs must create tissue or cell banks. The main reason for creating a new bank is a strong development of regenerative medicine, as well as the search for new therapies based on cells. Regulatory challenges are dominated by two issues: the heterogeneity of national procedures and requirements regarding regulatory dossier. Each concept is complex, as the clinical research of these products needs to be compliant both with clinical trial and ATMP-related regulatory requirements.
Cleanroom-As-A-Service (CAAS) for the ATMP market
Within our field of expertise, we have developed a unique cleanroom portfolio to serve any ATMP company regardless their size or development phase. Dieter Charle, International Sales Manager of ABN Cleanroom Technology, explains: “As a solution provider within the cleanroom business, it is key for us that our customers are able to focus on their core business, which means everything but the cleanroom facility. We are able to realize this by our modular cleanroom-as-a-service offering. Cleanroom-as-a-service means that our end-users do no longer need to own a cleanroom, but only finance a cleanroom per operational utilisation. With this approach, we enable ATMP companies to utilize their financial resources on their core activities without any long term compromises. If required, the existing cleanroom facility can be easily expanded by adding additional modules or upgraded towards higher grade classification at any moment in time.”
Due to the modular design and selection of circular materials, each module can be decommissioned and deployed for other purposes. Since each cleanroom module is pre-engineered, it is obvious that each module comes with the required documentation in order to execute pre-commissioning and factory acceptance tests. Once arrived at the end-user’s site and the facility is operational, a site acceptance test and site validation is executed by a certified validation engineer in order to provide the required quality management and validation to certify the cleanroom zoning according the specification requirements.
After the commissioning has taken place, the operating conditions of the entire cleanroom system and individual cleanroom assets are 24/7 remotely monitored by the ABN Cleanroom Technology Service team. A validated monitoring system can only be applied when each cleanroom module is equipped with various smart sensor technologies connected to a redundant control system that is securely connected to the ABN asset monitoring data-centre. Supported by smart analytics, the data gets translated into actionable information which enables our services team to perform condition-based maintenance in order to ensure a high reliable cleanroom facility at a maximized availability rate.
“The fact of already having a cleanroom facility should not be a drawback not to consider modular cleanroom solutions. Recently, an international bio-pharma supplier that specializes in genomics and proteomics based at the Liège industry cluster installed several modular cleanroom units while renovating their existing cleanroom facility. Our cleanroom-as-a-service solution enables them to continue their daily operations without any compromises and at the required quality standards for the future.”, concludes Jo Nelissen, CEO of ABN Cleanroom Technology.
Our modular cleanroom solutions connect strongly with the changing requirements and the diversity of today's biopharmaceutical products. ABN Cleanroom Technology will therefore be exhibiting at the B4B Connection Cell & Gene Therapies Vol.4 trade show at Charleroi Biopark on September 15 and 16.