LONDON, April 29, 2019: 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. The Freeline proprietary adeno-associated virus (AAV) manufacturing platform uses Pall’s iCELLis bioreactor system to achieve commercial scale and quality production of AAV gene therapy vectors. The two companies have now announced the extension of their partnership in order to accelerate in-house production of Freeline products.
Freeline now has its 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 that maximizes both quality and yield. The implementation of the manufacturing process in the Freeline facility at Catapult was made possible through integrated modeling 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 to reduce time to market. We are proud that our iCELLis technology now enables the development of Freeline’s life-changing therapies,” said Roel Gordijn, Vice President Integrated Solutions at Pall. “Pall continues to invest in its iCELLis technology, ensuring that it is available to the rapidly growing gene therapy industry.”
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Freeline is a privately-held clinical-stage biotechnology company focused on AAV based gene therapy targeting the liver. Our vision is to create better lives for people suffering from chronic systemic diseases using the potential of gene therapy as a one-time curative treatment. Freeline is headquartered in the UK and has operations in Germany and the US.
About Pall Corporation
Pall Corporation is a filtration, separation and purification leader providing solutions to meet the critical fluid management needs of customers across the broad spectrum of life sciences and industry. Pall works with customers to advance health, safety and environmentally responsible technologies. The Company’s engineered products enable process and product innovation and minimize emissions and waste. Pall Corporation serves customers worldwide.
The iCELLis bioreactor is an automated, single-use, fixed-bed bioreactor system which enables the commercialization of gene therapies by providing large scale manufacturing of high-quality viral vectors is a closed, scalable and reliable format. These features translate into greater patient access to life changing therapies.
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