October 2016 – BioFactura

BioFactura Granted Chinese Patent For Its StableFast^TM 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

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

Monthly Archives: October 2016

BioFactura Granted Chinese Patent For Its StableFast^TM Biomanufacturing Platform

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

Monthly Archives: October 2016

BioFactura Granted Chinese Patent For Its StableFastTM Biomanufacturing Platform

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

BioFactura Granted Chinese Patent For Its StableFast^TM Biomanufacturing Platform