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About BioFactura

BioFactura (Frederick MD) develops and commercializes high-value 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 10 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.

Enhanced expression of a biosimilar monoclonal antibody with a novel NS0 platform

Darryl Sampey, Pascal Courville, David Acree, Jeffrey Hausfeld and William E. Bentley.  Biotechnology Progress.  January 2018. The precise product quality and lower cost of goods demands of the growing biosimilars industry are driving biomanufacturing innovation. Biosimilar cell lines that produce complex glycoproteins such as monoclonal antibodies must be both highly productive and express a product … Continue reading

January 13, 2018 Publications

BioFactura, Inc. to Present at the Biotech Showcase™ Annual Conference on January 10th, 2018

Frederick, Maryland Jeffrey N. Hausfeld MD, MBA, Chairman and Chief Medical Officer, today announced that BioFactura will present at Biotech Showcase™ 2018, to be held January 8–10 during the most important week in healthcare at the Hilton San Francisco Union Square. Date: Wednesday, January 10, 2018 Time: 3:15 PM (PST) Room: Yosemite -B (Ballroom Level) Venue: … Continue reading

January 2, 2018 Press Releases

Governor signs Delegate Darryl Barnes’ House Bill 373 and Senator Roger Manno’s Senate Bill 226 to help Maryland Small Biotech Companies and Early Stage Biotech Innovators

Annapolis, Maryland Today, Maryland Governor Larry Hogan signed into law a measure aimed at providing additional support to Maryland small biotechnology companies.  Senate Bill 226 sponsored by Senator Roger Manno, and House Bill 373 sponsored by Delegate Darryl Barnes will support Maryland small and innovative biotech companies by amending the Biotechnology Investor Incentive Tax Credit … Continue reading

May 4, 2017 Press Releases

BioFactura Wins FRED Award for Its Frederick Maryland Development and Manufacturing Facility

Frederick County’s commercial real estate industry was honored this evening at the inaugural Frederick Real Estate Dealmakers (FRED) Awards. Hosted by the Frederick County Office of Economic Development, the FRED Awards recognized the most successful commercial real estate transactions and projects of 2016 – and the people who made them happen. The impacts on Frederick County’s economy … Continue reading

April 9, 2017 In The News

BioFactura Granted Chinese Patent For Its StableFastTM Biomanufacturing Platform

BioFactura, Inc. was granted patent rights by China’s State Intellectual Property Office (SIPO) protecting the core technologies of its proprietary StableFastTM Biomanufacturing Platform. SIPO allowed 17 claims broadly covering composition of matter and methods. StableFastTM is BioFactura’s proprietary NS0-based system to rapidly generate stable cell lines that have the potential to lower cost, produce follow-on … Continue reading

October 20, 2016 Press Releases

Biosimilar Therapeutic Monoclonal Antibodies: Gaps in Science Limit Development of an Industry Standard for Their Regulatory Approval, Part 1

Simran J. Kaur, Darryl Sampey, Lester W. Schultheis, Leonard P. Freedman and William E. Bentley.  BioProcess International.  October 2016. Biosimilars are biologically derived pharmaceuticals intended to have clinical similarity to a legally marketed innovator product when that product’s patent or market exclusivity has expired. By contrast with generic small-molecule drugs, clinical performance of a biologic … Continue reading

October 14, 2016 Publications

Momenta, BioFactura team up on biosimilars

From:  BioPharmaDive.com
By Suzanne Elvidge  22SEP2016

Getting biosimilars right at the manufacturing stage is vitally important, as there must be no clinically meaningful differences between the follow-on biologic and its reference product. Even small changes to cell lines can lead to major changes in how a biologic behaves, including its safety, efficacy and ability to trigger immune reactions. Creating an alliance with a biomanufacturing company… Continue reading

September 22, 2016 In The News

BioFactura Announces Entry into Non-Exclusive License Agreement with Momenta Pharmaceuticals

BioFactura, Inc., an emerging Maryland biopharmaceutical research and manufacturing company, announced today entry into a non-exclusive license agreement with Momenta Pharmaceuticals, Inc. (NASDAQ: MNTA), a biotechnology company specializing in the characterization and engineering of complex drugs, relating to one of the biosimilar product candidates that Momenta is developing.  As part of this non-exclusive license agreement, … Continue reading

September 21, 2016 Press Releases