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How to deal with potential contaminations of monoclonal antibody preparations
C J Lucas1, C F van Kreijl, A J van der Eb
1CLB, Amsterdam, the Netherlands.
Abstract:
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.