GMP facility for innovative drugs

INTOS contributed to the design, technical implementation, and finishing of these spaces, creating an environment optimal for advanced scientific research and the production of new therapies. With this facility, LUMC strengthens its position as a leader in the development of cell and gene therapies.

In realising the GMP facility for cell and gene therapy at LUMC Leiden, we faced several challenges:

Strict GMP requirements: Designing and setting up spaces that meet strict GMP standards was one of the biggest challenges. This required meticulous planning and execution to ensure that the cleanrooms and laboratories met the highest safety and quality standards for the production of innovative therapies.

Complex Technical Infrastructure: Integrating advanced technical installations in a controlled environment such as a clean room required extensive technical expertise. We had to ensure that all systems, from air treatment to process equipment, operated seamlessly and fault-free.

3.Collaboration with Multidisciplinary Teams: The project required close cooperation between different teams, including architects, engineers, and cell and gene therapy specialists. Coordinating these various areas of expertise to achieve a coherent end result was a logistical and organisational challenge.

4.Time planning: Given the urgent need for such facilities in the medical sector, it was essential to deliver the project within a tight schedule without compromising on quality.

INTOS offered specific solutions to successfully overcome the challenges in realising the GMP facility at LUMC Leiden:

Custom design and furnishing: To meet strict GMP standards, INTOS designed and implemented customised cleanrooms and laboratories. This ensured that each room was specifically adapted to cell and gene therapy requirements, including the necessary airflows, filtration, and hygienic finishes.

Advanced Technical Integration: INTOS integrated complex technical installations such as HVAC systems (heating, ventilation and air conditioning) and special process equipment in the clean rooms. By cooperating closely with specialised suppliers, INTOS ensured that all installations were perfectly matched and operated faultlessly.

Effective Collaboration and Project Management: INTOS deployed a strong project management team to ensure smooth cooperation between the various disciplines. This included frequent coordination meetings and clear communication between all parties involved, which was essential to complete the project within the tight timelines and quality standards.

Delivery within Time and Budget: Through proactive risk management and efficient planning, INTOS was able to deliver the project within the agreed time and budget, without compromising on the high quality standards required for such a facility.

These solutions ensured that LUMC now has a state-of-the-art facility ready to develop and produce advanced cell and gene therapies.