Sartorius Stedim BioOutsource Contract Testing Facility in Glasgow Successfully Passes FDA Inspection
Certified quality of analytical services for developers of biologics and biosimilars Goettingen, GER | Glasgow, UK – March 2, 2016: Sartorius Stedim Biotech (SSB), an international leading supplier for the biopharmaceutical industry, is pleased to announce that the Glasgow facility of its subsidiary Sartorius Stedim BioOutsource Ltd. has successfully passed an inspection by the U.S. More
Our Director of R&D and Technical Services, Dr. Catriona Thomson recently spoke to ‘Pharmaceutical Technology’ about the challenges of developing and validating an ADCC methodology, including the difference between the classical ADCC assay and the reporter bioassay. To read the full article please click here.
Rapidly reveals the factors to consider when using ADCC assays for producing precise biosimilar comparability data Glasgow, UK – November 17, 2015: Sartorius Stedim Biotech (SSB) BioOutsource today announced a new video is now available on-line explaining how to overcome the issues associated with using antibody-dependent cell-mediated cytotoxicity (ADCC) assays. The bite-sized video outlines the More
Offering scientists an opportunity for face-to-face meetings to discuss strategies for accelerating biosimilar development Glasgow, UK – November 12, 2015: Sartorius Stedim Biotech (SSB) BioOutsource today announced its expert technical staff will be speaking at and/or attending BIOLATAM, Biosimilars LATAM and Biosimilars and Biobetters conferences from November 16-19. This will provide developers of biosimilars with More
Presents data on factors that affect the sensitivity of ADCC assays and discusses how to optimise methodology Glasgow, UK – November 10, 2015: Sartorius Stedim Biotech (SSB) BioOutsource today announced a new paper entitled, ‘As easy as ADCC’ has been published in the respected journal, European Biopharmaceutical Review. The article outlines the factors affecting the More
Scientific poster from the BPI conference looking at orthogonal approaches for humira biosimilars.
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Scientific poster from the recent BEBPA conference looking at an interesting statistical approach for reporting potency of biosimilars.
Extensive regulatory requirements for analytical characterisation are now needed to prove comparability between innovator and biosimilar drugs. As a result, many developers are turning to ADCC assays which can help to unpick the issues of similarity, as well as guide the design process to create molecules to target specific activity. Download our article to find out more about the importance More
Cutting edge insight into the challenges of Biosimilar comparability studies View webinar here.