Massively Parallel Sequencing in Biopharmaceutical QC Testing – Is it too much information?

13th May 2011

Category: Biosafety

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By: Dr Daniel Galbraith, CSO,

There is a tendency towards conservatism utilising tried and tested methodologies in the safety and QC testing schemes designed for biopharmaceuticals, rightly so. In the early 1990s PCR was a useful research tool and was beginning to be used in targeted adventitious agent testing in cell lines and products, particularly virus vaccines, because of its More

Biosimilars – How similar must they be?

28th April 2011

Category: Biosimilars

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By: Dr Daniel Galbraith, CSO,

The hype over the market for biosimilars remains buoyant; research indicates that the market is likely to be worth almost USD$20 Billion by 2014. This increase is in some part driven by the major Asian players who have well over one third of the market. This push is in many ways due to the strong More

Coping with New Virus Risks in the Manufacture of Biologics

14th April 2011

Category: Biosafety

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By: Dr Daniel Galbraith, CSO,

In June 2009 a new virus was added to the growing list of agents found contaminating Chinese Hamster Ovary cells used in the manufacture of Biologics. Genzyme reported a contamination of CHO bioreactor with Vesivirus (subsequently named 2117); this was the third time such infection of a bioreactor had occurred in Genzyme. This virus which More

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