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.
Why One Size Doesn’t Always Fit All – Scientific poster on SPR binding methodologies using Biacore.
Associate Director of Technical Services, Catriona Thomson, writes about the development of a biosimilar.
Doubles the Company’s Capacity for Biologics Contract Testing and Biosimilar Characterisation in Response to Surging Demand, and Creates 50 New Jobs Glasgow, Scotland, July 27, 2015 – BioOutsource Ltd. (“BioOutsource”), part of Sartorius Stedim Biotech Group and a global leader in biologics contract testing and biosimilar characterisation for the biopharmaceutical industry, today announced the opening More
Aubagne, France / Goettingen, Germany, July 2, 2015 – Sartorius Stedim Biotech (SSB), a leading international supplier for the pharma and biotech industries, acquired Cellca GmbH based in Laupheim, Germany, last Wednesday. Founded in 2005, the company with around 30 employees generated sales revenue of approximately 6 million euros in 2014. Cellca’s major customers are More
Takeover expands SSB’s service portfolio Glasgow, April 17, 2015 – BioOutsource Ltd. (BioOutsource), a leading provider of contract testing services for the biopharmaceutical industry, has been acquired by Sartorius Stedim Biotech (SSB), a leading international supplier for the biopharmaceutical industries. BioOutsource provides contract testing services to Global biopharmaceutical clients in order to monitor the safety More
Biosimilars have caused a revolution in the development of biologic drugs. The model for biosimilars is a combination of speed to market and low cost; these are fundamental to any biosimilar development project. The biosimilars pathway to approval is not always without difficulty, biosimilars are still relatively new, and as each new applicant is reviewed we are learning more and more More