Freeline, a biotech company focused on developing curative gene therapies for chronic systemic diseases, together with Pall Corporation (Pall), a leading manufacturer of advanced biopharmaceutical processing technology, are pleased to announce the completion of the first full-scale run in Freeline’s newly commissioned Good Manufacturing Practice (GMP) facility located at the Cell and Gene Therapy Catapult (Catapult) facility in Stevenage, UK.
Freeline now has their manufacturing platform successfully implemented for GMP manufacturing at three locations as it continues to progress and expand its manufacturing capabilities. The adherent cell culture format used in this system, together with the scale and automation provided by the iCELLis® bioreactor, allow for highly efficient production of the AAV virus in a way which maximizes both quality and yield. The implementation of the manufacturing process in the Freeline facility at the Catapult was made possible through integrated modelling processes and design features completed in collaboration with Pall and takes advantage of the small footprint of the bioreactor.
Jan Thirkettle, Chief Development Officer of Freeline said; “This is an important step forward for Freeline as we look to manufacture product for clinical trials with a commercially-ready manufacturing platform in order to ensure the fastest possible development towards licensure. Our collaboration with Pall has been critical to our progress and we are excited to be working with them as we prepare for commercial supply and further development of our proprietary AAV manufacturing technology.”
“The partnership between Pall and Freeline has been rewarding for both sides. The iCELLis® Bioreactor System coupled with Pall’s Accelerator™ Process Development Services helped deliver a robust and scalable process for Freeline reducing time to market and we are proud to see our iCELLis® technology now enabling the development of the Freeline life changing therapies,” said Roel Gordijn, Vice President Integrated Solutions at Pall. “Pall continues to invest in the iCELLis® technology ensuring that it is available to the rapidly growing gene therapy industry.”