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EMA accepts MAA for Sandoz’s biosimilar etanercept

8 December 2015 | By Victoria White

Sandoz is seeking approval for all indications included in the label of the reference product which is used to treat a range of autoimmune diseases including rheumatoid arthritis and psoriasis...

BioOutsource Bioanalysis experts attending major Biosimilar Conferences November 16-19

12 November 2015 | By

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 an excellent opportunity to discuss the optimum assay design for rapid and accurate biosimilar characterisation…

Cyber security in pharmaceuticals

22 October 2015 | By Caroline Rivett and Dr Cornelius Namiluko at KPMG

Dr Cornelius Namiluko and Caroline Rivett discuss cyber security in the pharmaceutical industry and the approaches companies can take to address the risk of a cyber attack...

New third-party audit scheme for excipient suppliers

22 October 2015 | By Iain Moore, President, EXCiPACT asbl

There has always been a regulatory requirement for pharmaceutical manufacturers to audit their starting material suppliers, but the expectations are even clearer now that these audits, including those for excipients, have to be in vivo. With increasing requirements for physical audits, can all pharmaceutical companies address the number of audits…

Dynamic vapour sorption of freeze-dried pharmaceuticals

22 October 2015 | By Claudia Kunz and Henning Gieseler, Department of Pharmaceutics, University of Erlangen

Freeze drying is gaining in importance as the number of biopharmaceuticals that are unstable in a solution increases. According to recent reports, a growth of 10% may be expected for freeze-dried products in the next 10 years. The technique offers the opportunity to gently dry temperature-sensitive drugs such as proteins…