Agreement Builds on Successful Transfer of the Freeline Commercial Scale/Quality AAV Manufacturing Platform and Initiation of GMP Manufacture at Brammer Freeline announced today it has signed a multi-year agreement with Brammer Bio (Brammer), a leading gene therapy contract development and manufacturing organisation, to secure a dedicated AAV manufacturing suite in Brammer’s state-of-the-art Cambridge, MA facility. This agreement will allow Freeline to meet the commercial demand of the FLT180a program for Haemophilia B. Freeline has now deployed its iCELLis®-based mammalian cell manufacturing at three separate locations, including Brammer, the Cell and Gene Therapy Catapult outside of London, UK, and at a European CMO.
“We invested early in CMC, manufacturing and analytics, and have built our own robust and flexible manufacturing platform focused on quality at scale,” said Jan Thirkettle, Chief Development Officer, Freeline. “The impressive commercial-supply capabilities of Brammer Bio’s Cambridge US facility, alongside our existing suppliers, secures our commercial supply for Haemophilia B, as well as our future development pipeline.”
"Brammer Bio and Freeline have been working closely together since 2017 to establish the Freeline iCELLis based manufacturing platform in readiness for late-phase clinical studies, and we are delighted to expand our strong relationship through this agreement,” said Mark Bamforth, president and CEO, Brammer Bio. “It is an exciting time for us as we look forward to joining Thermo Fisher Scientific and leveraging their industry-leading scale and capabilities to support the growth of gene therapy companies like Freeline."
Brammer Bio operates with extensive experience and expertise in the supply of gene therapy products for clinical trials and the establishment of commercial-ready processes. As a leader in viral vector manufacturing for gene and cell therapies, the Company will play a key role in the progression of the Freeline lead programme towards market supply. Brammer offers a wide range of viral vector manufacturing platforms to translate genes into vectors and to purify these vectors for eventual clinical distribution and patient delivery.
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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 Brammer Bio:
Brammer Bio provides clinical and commercial supply of vectors for in vivo gene therapy and ex vivo gene-modified cell therapy, along with process and analytical development, and regulatory support, enabling large pharma and biotech clients to accelerate the delivery of novel medicines to improve patients' health. Brammer is Helping to Cure®. Brammer is owned by Ampersand Capital Partners, the only institutional investor in the company, and its founders. For more information, please visit www.brammerbio.com. On March 24, Thermo Fisher Scientific and Brammer Bio announced they have entered into a definitive agreement under which Thermo Fisher will acquire Brammer Bio.