In the biotech sector, interest in advanced therapies is growing and a growing biotech company is taking the lead in developing Pharma for Advanced Therapy Medicinal Products (ATMPs). Their focus is on unique and personalized cell therapies targeting cancer, a pioneering approach in medical research. Like other medical products, quality requirements are high and to ensure product stability, reproducibility and above all patient safety, they must follow cGMP guidelines during manufacturing and storage.
After successful results in Phase I and II clinical trials, the company is ready to take the next step and establish a GMP Class A-D (ISO 5-8) cleanroom facility for the manufacture of its clinical product. With a sterile product, high demands are placed on aseptic manufacturing to ensure product quality and thus patient safety.
What challenges did the company face on its way to securing its Location in the future of advanced therapies? And how did they overcome these to achieve success?
The right resources with the right expertise in the right place Location
The challenges were many when the project team took on the task of building cleanroom facilities for manufacturing ATMP products from scratch. From starting with an empty facility in central Sweden to establishing a complete QMS system with SOPs, work instructions and risk audits, the journey was intense and required almost 18 months of dedicated work before the goal was achieved.
What challenges did we face along the way and how did we overcome them?
One of the biggest challenges was making the transition from a research environment to a GMP cleanroom environment for the company's process engineers and scientists. Many had extensive experience working in R&D, but little or none in GMP. Preparations would need to be made to make the transition, not least in terms of their training and involvement in the process.
Another key question that arose at an early stage was: "What exactly is ATMP and how do the requirements for manufacturing differ from other medical devices?" In a rapidly emerging sector like ATMP, where the requirements are new to many, it was crucial to understand and adapt to the new reality. We needed to ensure we had the right knowledge and the right resources at Location to best meet the challenge. The resource needs for validation activities were also a constant challenge, especially given the prioritization between the GMP project and other business projects.
In order to successfully drive the project forward, it was important that we balanced the requirements and that we had sufficient resources.
Through collaboration, commitment and a strong will to overcome obstacles, we managed to secure the manufacturing authorization for the ATMP products. But the journey does not stop here. What lessons can we learn from this project and how can we use them to continue our successful journey in the ATMP sector and beyond?
Establishing GMP cleanrooms: from vision to reality
The objective of our assignment was clear: to assist the company throughout the process of establishing, qualifying and validating a GMP cleanroom facility for the manufacture of biological Pharma (ATMP) and to establish a QMS system and thereby become GMP certified for the manufacture of this type of Pharma. One of the project managers was responsible for leading the implementation of aseptic working methods within the future GMP cleanroom facility and to provide microbiological expertise throughout the scope of the project.
The project involved a number of key steps, including the set-up and qualification of cleanroom facilities for the aseptic manufacture of ATMPs and the development of Aseptic Process Simulation (APS, media filling) and work instructions for cleanroom procedures. In addition, training of personnel according to the applicable regulations was included to ensure that all involved had the necessary competence to work in a GMP environment.
With our experience and expertise in the field, we were able to guide and support the company and its employees through all stages of the project, from cleanroom requirements to regulatory inspections and everything in between. By combining our technical expertise with an in-depth understanding of industry-specific requirements and best practices, we were able to ensure that their goals were achieved successfully and efficiently.
In the initial stages of the project, the project team consisted of a selection of consulting resources with specialized skills carefully selected to meet the needs of the company and to ensure compliance with all regulations. The focus was on identifying and mapping the specific requirements of the regulations and ensuring the availability of the necessary resources to drive the project forward with high quality.
"In the role of sub-project manager and validation manager for aseptic manufacturing, I had a broad scope of responsibilities that covered several key elements. This included designing cleanrooms adapted for aseptic manufacturing, preparing validation plans and conducting risk analyses to ensure the effectiveness and safety of the cleanroom and the aseptic approach.
We also designed cleanroom qualification and validation documentation, performed aseptic process simulations and visualized air flows. To ensure compliance with GMP standards, we also established a range of cleanroom procedures based on the specific needs of the company and its operations. This included the development of SOPs, forms and work instructions for various steps related to the aseptic approach, dressing, cleaning, material handling, and documentation.
In addition, training and certification of staff was carried out in all areas to ensure their competence and eligibility to work in cleanroom facilities and aseptic manufacturing", says Emina Vorkapic, Consultant QM, Plantvision Compliance.
Successful project with important milestones achieved
The efforts resulted in well-functioning and high-quality GMP cleanroom premises, established QMS system and certified personnel for cleanroom work and clinical product (ATMP) manufacturing, in accordance with the set requirements for ATMP manufacturing. The authorities inspected the company and with a strong focus on cleanroom validation and validation of the aseptic processes, the project team delivered a well-executed project that resulted in our client receiving its manufacturing license from the Medical Products Agency.
"Our new and approved cleanroom facilities will facilitate the aseptic manufacturing of ATMP and clinical material in future studies and enable the conduct of larger clinical studies with our product. We are incredibly happy and proud to have obtained manufacturing authorization, an important milestone has been reached. Our in-house GMP cleanroom facility provides us with valuable capacity, flexibility and control over our clinical manufacturing. The company is now well positioned for significant and value-creating development in the coming years" - Company CEO
Thank you Emina for the insight into one of your exciting projects that ended with a very satisfied client!
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