Archives for June 22, 2015

apceth expands gene, cell therapy manufacturing business

German-based contract manufacturer apceth has received regulatory approval to use two new GMP cleanrooms for aseptic processing, which will be used for the handling and genetic manipulation of various types of cell and gene therapies. 

BIO 2015

TTIP trade talks will 'force' FDA-EMA to sync regs, says biopharma

Eli Lilly’s President of Biomedicines says the transatlantic trade agreement TTIP will “force” the FDA and EMA to standardise regulations on manufacturing and trials.

BIO 2015

Does second prequalified vaccine mark China as ‘true global player’?

China is set to become a major vaccines manufacturer for emerging markets once it untangles some regulatory quirks, says a panel at BIO 2015.