Exyte has completed the construction of the first ExyCell facility in China, the CliniMACS Cell Factory of Miltenyi Biotec, a provider of integrated solutions for advanced therapy medical products (ATMPs). ExyCell technology was developed by the company as an integrated facility solution with standardised and modularised elements. The pre-configured and pre-fabricated modules are designed to enable fast-track construction, thereby shortening time-to-market for therapeutics and vaccines.
The ExyCell facility is installed on the fourth floor of the ATLATL building located in the Zhangjiang High-Tech Park, and Miltenyi Biotec is now transferring production technology from Germany to China. ATMP production is expected by autumn 2021, and the facility will soon be open to visitors by appointment.
The pre-configured and pre-fabricated modules are designed to enable fast-track construction
The facility combines the CliniMACS Cell Factory manufacturing platform with the pre-fabricated ExyCell module enabling deployment of small, medium, and large scale cell manufacturing facilities based on a flexible cell therapy manufacturing module. End users can purchase a personalised version of the manufacturing module ready, to host their CliniMACSCell factory for ATMPs.
Chris Miller, President Global Business Unit Biopharma and Life Sciences at Exyte said: "The completion of the first ExyCell facility with our partner Miltenyi Biotec marks an important milestone. We consider ExyCell to be a transformational development of our "next generation" of award winning modular concepts." Exyte has developed and implemented other modular facilities including the Catapult Development and Manufacturing Centre for cell and gene therapy in Stevenage, UK.
Dr Boris Stoffel, Member of the Management Board of Miltenyi Biotec, said: "As a company, we want to enable our customers in their efforts to make innovative cell and gene therapies available to patients worldwide. We believe that combining the proven CliniMACS Cell Factory manufacturing platform with the pre-fabricated ExyCell module will help fast-tracking new therapies to the benefit of global healthcare."
The combination of the CliniMACS Cell factory ballroom concept built into the ExyCell module is aimed to allow the flexibility to build, scale-up, expand, or repurpose a facility with minimal impact to ongoing production operations. The platform can either be purchased in its standard version or adapted to specific needs of production capacity, cleanroom size, control systems, and finishing options. Exyte says it can build and qualify a turn-key facility in months.
ExyCell facility sizes start from 75 sqm for an operational turnkey facility hosting a CliniMACS Cell Factory with one to twelve CliniMACS Prodigy units, scaling up to several thousand square meters to accommodate several hundred units. The facility can be either realised in an existing building or built in a greenfield setting and is adaptable to any process layout and meets the requirements for cGMP.
