Safety of biopharmaceuticals: a current perspective.
The impetus for this conference comes in large measure from the continuing development of the ICH Viral Safety document concerned with testing and evaluation of the viral safety of biotechnology products derived from characterized cell lines of human or animal origin [1]. My opening remarks for this conference were, I think, suggested by the organizers in the belief that George Santayana's quote, "Those who cannot remember the past are condemned to repeat it" has validity for this effort. In this brief review I have tried to recall some past unfortunate episodes and outline the lessons that they might have for us. I have also attempted to outline a number of issues which I believe are critical to the success of efforts to guarantee, as much as humanly possible, the safety that we seek balanced against our ability to develop and use important new products.
Parkman
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Parkman Associates, Kensington MD, USA.
D000818:Animals; D001354:Avian Leukosis Virus; D002642:Chick Embryo; D004340:Drug Contamination; D049673:History, 20th Century; D006801:Humans; D011054:Poliovirus Vaccine, Inactivated / Q000009:adverse effects; D011055:Poliovirus Vaccine, Oral / Q000009:adverse effects; D013539:Simian virus 40; D014765:Viral Vaccines / Q000266:history* / Q000592:standards; D015005:Yellow fever virus
D011054:Poliovirus Vaccine, Inactivated; D011055:Poliovirus Vaccine, Oral; D014765:Viral Vaccines