12:00 AM
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Aug 10, 2009
 |  BioCentury  |  Regulation

PEGging Krystexxa

Following a positive panel review in June, Savient Pharmaceuticals Inc. expected to spend the week leading up to its Aug. 1 PDUFA date finalizing the launch of its Krystexxa pegloticase for chronic refractory gout candidate. Instead, the biotech will have to spend the next three to six months revalidating its manufacturing process after receiving a complete response letter from FDA.

Krystexxa is a tetramer composed of four urate oxidase (uricase) monomers, with strands of PEG attached to specific spots on each monomer.

Manufacturing for the Phase III program began in 2005. In 2006, Savient began validation runs for commercial production. But the company tweaked the commercial manufacturing process, decreasing the amount of PEG added during the pegylation step compared to the product it used in its clinical trials.

"We have a range of specification of nine plus or minus one PEG per monomer. When we did our Phase III batch, we had slightly more than nine but were still in the plus/minus range. We wanted to adjust down that...

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