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In collaboration with Pall Corportion, biotech company Freeline completed the first full-scale run at its newly commissioned, GMP gene-therapy manufacturing facility in the UK.
On April 29, 2019, Pall Corporation, a manufacturer of biopharmaceutical processing technology, and Freeline, a biotech company focused on developing gene therapies for chronic systemic diseases, announced the completion of the first full-scale run in Freeline’s newly commissioned GMP facility located at the Cell and Gene Therapy Catapult facility in Stevenage, UK. The Freeline proprietary adeno-associated virus (AAV) manufacturing platform uses Pall’s iCELLis bioreactor system to produce AAV gene therapy vectors. The two companies will extend their partnership to accelerate in-house production of Freeline products.
With the scale and automation provided by the iCELLis bioreactor, the adherent cell culture format used in the new system allows for the production of the AAV virus in a way that maximizes quality and yield, Pall reports. The manufacturing process at the Freeline facility at Catapult was achieved in collaboration with Pall through integrated modeling processes and design features. The platform is used at three locations as Freeline continues to expand its manufacturing capabilities.
“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,” said Jan Thirkettle, chief development officer of Freeline, in a company press release. “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 iCELLis bioreactor system, coupled with Pall’s Accelerator [p]rocess [d]evelopment [s]ervices, 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, in the release. “Pall continues to invest in its iCELLis technology, ensuring that it is available to the rapidly growing gene therapy industry.”
Source: Pall Corporation