Biofactura Granted New US and European Patents for it's Stablefast Biomanufacturing Platform

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BioFactura’s Multiplex Selection Patent Enhances the Commercial Production of our Biosimilar and Biodefense Assets

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“These timely new patents further extend protection of BioFactura’s StableFast platform beyond 2030 strengthening our competitive advantages as we begin clinical development of our biosimilar products next year,” said Darryl Sampey, BioFactura’s President and CEO.

BioFactura, Inc. was issued a new patent in the U.S. and also granted patent coverage in the EU for novel technologies that improve the productivity of its proprietary StableFastTM Biomanufacturing Platform. The new Multiplex Selection components of the platform allow for concurrent selection strategies to be applied during stable cell line development leading to higher transgene copy number, increased genetic stability and up to 10-fold higher specific productivity of biological products.
Cells subjected to Multiplex Selection recover faster and in greater numbers than traditional single selection pressure strategies presenting a broader choice of optimal manufacturing cell line and decreased cost of goods.

StableFastTM is BioFactura’s proprietary NS0-based system that lowers production cost, produces fingerprintmatched
biosimilars and is fully single-use manufacturing compatible. With this platform, the Company is developing and commercializing high-value biosimilars and biodefense medical countermeasures.

“These timely new patents further extend protection of BioFactura’s StableFast platform beyond 2030 strengthening our competitive advantages as we begin clinical development of our biosimilar products next year,” said Darryl Sampey, BioFactura’s President and CEO.

Dr. Jeffrey Hausfeld, Chairman and Chief Medical Officer, stated, “This patent is a prime example of how innovation by bright and forward-thinking scientists can translate directly to better medicines for our patients. BioFactura is committed to generating high-value technology to achieve our goals of superior product quality, unrivaled analytic comparability, and increased patient accessibility on our commercialization path.”

About BioFactura
BioFactura (Frederick MD) develops and commercializes high-value, highly similar biosimilars (i.e., follow-on biologics or generic biopharmaceuticals) using its patented StableFast™ Biomanufacturing Platform, the optimal system for bringing these drugs to market with faster, lower cost, superior-quality manufacture. For over 15 years, BioFactura has been advancing life-saving medicines from the research bench to the patient using its innovative drug development and manufacturing technologies. Current and past programs include biodefense drugs against smallpox and Ebola, novel medicines for cancer, and low-cost/high-quality biosimilars for autoimmune and infectious diseases.

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Jeffrey N. Hausfeld M.D., M.B.A., F.A.C.S.
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