Monthly Archives: %sOctober 2014

Biotherapeutics Manufacturing

I’m attending the BioProcessing Network Conference (21-23 Oct 2014) in Melbourne this week. It’s got me thinking about the major changes to biotherapeutics manufacturing. One of these significant changes has come about as a consequence of increased yield; when the quantity of product increases from mg/L to g/L then the scale of manufacturing can […]

By |October 21st, 2014|Manufacturing|0 Comments

Tissue and Cell Therapies

The TGA introduced the Biologicals Regulatory Framework in 31 May 2011. This new regulatory guidance had a three year transition which finished in May 2014. There is some confusion with regard to the terminology – ‘biologicals’ by the TGA definition include human tissue and cell therapies which are termed Advanced Therapies in other jurisdictions […]

By |October 13th, 2014|Biologicals and Biopharmaceuticals|0 Comments

Cell Banks: the Foundation of Biotechnology/Biological Products

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By |October 10th, 2014|Biologicals and Biopharmaceuticals|0 Comments

Orphan Drugs (Part 2)

The European Medicines Agency (EMA) has recently released an updated guidance document with regard to Orphan Drug Applications. The FDA and EMA have a common application form which covers application for Orphan Drug designation in both the US and European Union and parallel applications are encouraged by the regulator – principally to encourage the […]

By |October 8th, 2014|Drug Regulation|0 Comments