Advanced therapy medicinal products (ATMPs) based on genes, tissues or cells offer revolutionary new opportunities for treatments of disease and injury. One of the challenges with ATMPs is that Good Manufacturing Practice (GMP) is necessary to ensure control and safety as research transitions to production. However, since the new manufacturing processes for ATMPs often are quite complicated and unconventional, it can be difficult to adapt the current GMP knowledge and regulations to the new products. The CAMP-project “GMP education and training courses focused on ATMPs” is aiming to develop and implement a comprehensive GMP educational program with a specific focus on ATMPs.
As a project partner, Key2Compliance has worked closely with the project leader Anna Pasetto from the Karolinska Institute, to develop on-demand- and VR-training focused on GMP for the ATMP-area. The development will not only establish common practice and guidelines in the field, but also use cutting-edge training formats to make it possible to share common educational and training programs across the field.
A collaboration that benefits the patient
Anna Pasetto, Karolinska Institute (KI)
The Centre for Advanced Medical Products (CAMP) is, among other things, a project focusing on the collaboration between researchers, GMP competent resources, industry and hospitals. As a Senior Researcher at the Karolinska Institute (KI), and former managing director of the pre-GMP facility in the department of Laboratory Medicine, Anna Pasetto has the right background for leading a CAMP-project aimed at developing GMP education and training courses focused on ATMPs. In her work with taking ATMPs from research to actual therapy, Anna has learned that there is a big educational gap when it comes to GMP, she states that “There’s both a lack of training and different languages between research and GMP in the ATMP-area”.
One important part of the CAMP-project has been to develop a standardised training program that could go beyond KI and be used on a national level – probably with project partners such as the universities of Lund, Uppsala and Umeå, and Region Västerbotten. For Anna Pasetto it was a natural step to involve Key2Compliance as a project partner, and continues, “We needed Key2Compliance to make this project happen. They had the competence, the knowledge and the tools to create the education we needed. Their role has been to give professional assistance, and while we’ve been brainstorming around what the users needed, what kind of problems that were often encountered, Key2Compliance have had the tools to solve the problems.”
Anna Lundén, Key2Compliance
It has been very natural for Key2Compliance to be a part of this project, as their vision is to be a part of collaborations that ultimately leads to something that benefits the patient. Anna Lundén is one of the founders of Key2Compliance and was the Director of Training and Courses when the project began (this position is today held by Magnus Jahnsson). For her, using knowledge and adapt it to the needs is what Key2Compliance is all about. “We want to help taking these ground-breaking therapies to the patient. To contribute in a way that presents the knowledge in an effective way that makes a product reach the patient faster and safer, is in the heart of what we do and the passion that drives us at Key2Compliance. We are very proud to be part of this project.” Anna Lundén says.
On demand- and VR-training for a safer and more effective education
Key2Compliance have already been doing GMP-training for audiences in the ATMP area, and have the experience needed to find the most effective way for doing this. One of the lessons learned is how much more effective on-demand training can be in this and other areas. If a person in need of training can download the material, and start learning at any time, it’s more cost effective at the same time as it increases the effectiveness of the learning process. With the on-demand concept the user can get the knowledge in the moment it’s needed and then use it straight away. The user can also pause and repeat the training for a better learning experience. On-demand has proven to take less than half the time compared to traditional training. At the same time there’s less costs for travel and time away from operations.
Anna Pasetto sees the many benefits of on-demand training. “It’s the best solution for the people who have to take the course, but also for us. In this area, people come in all through the year so it’s difficult to gather them in one place at the same time. What we achieve with on-demand is that we save time and ensure that everybody gets the same introduction and training. A traditional training performed by different educators/trainers can differ even if we follow the same protocol. A recorded education is the ideal solution since it’s the same person giving the exact same information every time.”
Another challenge in developing GMP-training for ATMP is the cleanroom training. There is a kind of Catch 22-situation in this training where you can’t allow an untrained person to enter a cleanroom, but the untrained person still needs to learn the correct procedures through practical hands-on training. The solution to this dilemma is Virtual Reality-training. By using VR to simulate the procedures in a cleanroom it’s possible to make a person more prepared, which makes the actual on-site training both safer and shorter. Anna Pasetto discovered that not only was this an effective way of training, it was also something the audience took to in a natural way. “VR is already a familiar tool among the younger PhD students, and the trainees can do the sessions on their own. To integrate new technology into the training makes it so much more effective. A full traditional GMP-training can take up to a year. With this new training platform we could achieve the same standard and quality but with reduced training time, which ultimately means it will go faster to get the product to the patient.”
During this project, Key2Compliance has not only managed to put the benefits of on-demand training into practical use. Key2Compliance has also learnt a lot about how to use VR-training in the many practical aspects of lab-work. Like how to make people familiar with sequences and environments in small premises with rigorous safety protocols, in a safe and effective way. Anna Pasetto sees the many benefits of VR-training. “VR is good because you can later add on more training, more modules, expand training, adapt it to specific needs etc. and we still use a standardised format where everyone gets the same training. The more we work together in this area, the more we can come up with similar systems and procedures and build a consistency in the field of ATMP. On-demand and VR-training can be distributed across borders, and the training we developed here in Sweden can be used internationally. The aim is to develop a system that facilitates good international collaborations. It’s easier to offer treatment to patients all over the world if we work together.”
For Anna Pasetto, this project is only the beginning of the work of finding ways to bring ATMP-treatments to as many patients as possible in a safe and effective way. “This is just the beginning as we want to expand and continue, and I would love to continue to collaborate with Key2Compliance.”
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