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