Tuesday, February 12, 2019 Daily Archives

The Changing Landscape of Single Use in Bioprocessing: An Interview with Stefan Schlack and Jean-Marc Cappia

Single use in bioprocessing has changed significantly in recent years. To find out how a leading supplier to the biopharmaceutical industry is redefining its technology to align with new market challenges, science writer, Sue Pearson, had the opportunity to interview Stefan Schlack, Head of Bioprocess Marketing, and Jean-Marc Cappia, Head of Segment Marketing Vaccines, both at Sartorius Stedim Biotech (SSB) in Goettingen, Germany. Redefining Single Use Pearson: Sartorius Stedim Biotech is a recognized leader in single-use technology, and you’ve recently…

Ask the Expert: Preparing for and Managing Regulatory Inspections

An “Ask the Expert” webinar on 27 November 2018 featured Ray Marzouk, vice president of quality at Avid Bioservices, a biologics contract development and manufacturing organization (CDMO) in Orange County, CA. With six successful preapproval inspections behind it, Avid prides itself on a 13-year industry-leading regulatory track record. Marzouk’s Presentation Preparing for the Inspection: Implement a standard operating procedure (SOP) for inspections that includes instructions for the receptionist, host, scribe, subject matter experts (SMEs), and document finders. Prepare SMEs for…

Samsung Bioepis inks biosimilar deals to enter China

Samsung Bioepis has teamed with C-Bridge Capital to bring its third-wave biosimilars to the Chinese market. C-Bridge will establish a new company, AffaMed Therapeutics, under terms of the deal, and will license multiple biosimilar candidates from Samsung Bioepis to commercialize in China. These include the third-wave biosimilar candidates SB11 and SB12 – versions of Roche/Novartis’ Lucentis (ranibizumab) and Alexion’s Soliris (eculizumab) – and SB3, a biosimilar of Roche’s Herceptin (trastuzumab). The deal comes weeks after a partnership deal with 3SBio…