Home » GSK: Trypsin May Be Rotarix Contaminant, FDA to Convene Advisory Panel
GSK: Trypsin May Be Rotarix Contaminant, FDA to Convene Advisory Panel
GlaxoSmithKline (GSK) is honing
in on a possible source of the DNA fragments found in vials of its Rotarix vaccine, less than a month before an FDA panel meets to review the problem and
consider possible solutions. Preliminary investigations suggest trypsin, a digestive enzyme used to establish the master cell bank for the vaccine, may
be a source of the contamination with porcine circovirus 1 DNA. However, further testing is needed to confirm the preliminary findings, GSK spokeswoman
Sarah Alspach said.
Drug Industry Daily
Drug Industry Daily
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