#Germany #Munich #Cell Therapy #Minaris Advanced Therapies #GMP Facility

Minaris Advanced Therapies Opens New GMP Facility in Munich

In a significant move for the advancement of cell and gene therapy, Minaris Advanced Therapies has inaugurated a new state-of-the-art GMP (Good Manufacturing Practice) facility in Taufkirchen, near Munich, Germany. This modern facility will serve as a pivotal point for supporting the global growth of innovative therapies, enhancing the company’s ability to meet the increasing demand within the healthcare landscape.

The newly opened facility marks a key milestone in Minaris' mission, leveraging over a decade of experience in clinical and commercial manufacturing. It serves as a central hub for the technology transfer of commercial advanced therapies into the European market, consolidating various operations—including process and analytical development—under one roof for better efficiency and effectiveness.

Strategic Advantages of the New Facility

Located just a short drive from the Munich International Airport, this facility offers exceptional logistical advantages for clients across Europe and beyond. The site is equipped with:

• - Six Grade B/A cleanrooms for aseptic manufacturing: These cleanrooms are designed to maintain stringent environmental controls necessary for the production of high-quality therapies.
• - A Grade C cleanroom for bioreactors: The design of the cleanroom allows for closed systems and has convertible capabilities to Grade A/B standards, enhancing flexibility in production processes.
• - Customizable configurations and expansive space: With 224 m² of expansion area, the facility is designed to adapt to the varying needs of clients, ensuring scalability.
• - Independently controlled HVAC systems: Each cleanroom suite is equipped with its own climate control, minimizing downtime and enabling simultaneous production runs for different projects.
• - Dedicated laboratories for process development and quality control: This focus on quality ensures that all therapies produced meet the highest standards before reaching patients.

Additionally, the facility houses cryopreservation and storage facilities along with advanced safety systems designed to protect personnel and products alike. These features not only enhance operational capacity but also allow Minaris to respond rapidly to client needs with high-quality solutions.

Leadership Insights

The official opening ceremony took place on July 31, celebrating the facility’s impact with various stakeholders in attendance. Dr. Orla Cloak, CEO of Minaris Advanced Therapies, emphasized the strategic importance of this site: “The opening of this facility marks an important milestone in our mission to accelerate the development and manufacturing of transformative cell and gene therapies globally. It enhances our European footprint and enables us to meet client needs with speed, quality, and scalability.” The successful transition into this facility showcases the dedication of the local team and reiterates the company’s commitment to delivering enduring value to its clients and patients worldwide.

Iain Baird, Chairman of the Board, reiterated this vision, stating, “This facility embodies our shared vision for the future of cell and gene therapy manufacturing—scalable, flexible, and globally integrated.” The collaborative efforts of the Minaris team play a crucial role in navigating the complexities associated with developing advanced therapies, ensuring that the company remains at the forefront of industry advancements.

Minaris Advanced Therapies at a Glance

Minaris Advanced Therapies is a global contract development and manufacturing organization with a focus on the burgeoning field of cell and gene therapies. With its headquarters in Philadelphia, Pennsylvania, the company boasts over 650,000 square feet of advanced infrastructure across the United States, Europe, and Asia. Over the years, it has successfully manufactured and released over 7,500 GMP batches, solidifying its reputation as a trusted partner for therapy developers from early-stage development through clinical trials to commercial production.

By embracing innovation and customer-centric approaches, Minaris Advanced Therapies reaffirms its commitment to enhancing patient outcomes through the development of essential therapies that address critical healthcare needs.