First ExyCell® Biopharmaceutical Facility Unveiled in Shanghai
Stuttgart, 07. December 2021. Stuttgart, Exyte and Miltenyi Biotech recently celebrated the opening of the first ExyCell facility, the CliniMACS Cell Factory® of Miltenyi Biotec, in Shanghai, marking an important milestone. Local officials, industry leaders, and top executives from both companies attended the opening ceremony alongside some 100 guests.
Fast time to market and great flexibility are crucial in the personalized medicine market. The new facility pairs the CliniMACS Cell Factory manufacturing platform with the pre-fabricated ExyCell modular cleanroom to enable fast rollout of small, medium, and large-scale cell manufacturing facilities. ExyCell technology provides the underpinning for a modular and expandable facility that readily adapts to suit biopharmaceutical manufacturers’ production needs and budget without any downtime. This technology was integrated with Miltenyi Biotec’s unique manufacturing platform to provide an innovative, sustainable, and effective solution for cell therapy manufacturing.
Innovations in process and facility technologies are changing the biopharmaceutical landscape in what continues to be a very dynamic market. Chris Miller, President of the Exyte Global Business Unit Biopharma and Life Sciences, said, “The new ExyCell incorporates over 50 years of Exyte experience in cleanrooms and a more recent history of successful design of traditional and modular biopharmaceuticals facilities, recognized with several ISPE Facility of the Year awards.”
Exyte manufactures ExyCell modules at three locations around the world. They serve to standardize and optimize operations to use materials more efficiently and minimize waste on site for more sustainable manufacturing. Exyte’s global technology team joined forces with local implementation experts in China, enabling the project team to rapidly build the ExyCell. The journey from fabrication to validation took just twelve weeks. Frank Lorenzetto, Vice President of Exyte Northeast Asia, stated, “We are excited to be involved in both the global and local biopharmaceuticals market at this amazing time in the industry, with so many new technologies and innovations becoming available.”
Dr. Boris Stoffel, Member of the Management Board of Miltenyi Biotec, emphasized the importance of this facility: “As a company, it is our goal to enable our customers in their efforts to make innovative cell and gene therapies available to patients. Combining the proven CliniMACS Cell Factory manufacturing platform with the pre-fabricated ExyCell module will make an important contribution by helping to fast-track new therapies to the benefit of global healthcare.”