How to deal with potential contaminations of monoclonal antibody preparations.
The message of this contribution is that simple and concrete regulatory rules can not yet be established. We may have added vagueness. We would welcome a dialogue between researchers, manufacturers and regulatory authorities. Prerequisite for a fruitful discussion among all parties will be the availability of information on several aspects of this problem.
Lucas
C J
CJ
CLB, Amsterdam, the Netherlands.
van Kreijl
C F
CF
van der Eb
A J
AJ
D000818:Animals; D000911:Antibodies, Monoclonal / Q000592:standards*; D004247:DNA / Q000032:analysis; D006801:Humans; D009426:Netherlands; D009858:Oncogenic Viruses / Q000302:isolation & purification; D011506:Proteins / Q000032:analysis; D014944:World Health Organization
D000911:Antibodies, Monoclonal; D011506:Proteins; D004247:DNA