EXTRANEOUS AGENTS TESTING.

摘要

The present invention belongs to the field of pharmaceutical industry and specifies a method for testing extraneous agents in a composition comprising at least one active agent, comprising the steps of: a) contacting an antibody, which had been raised against an expression product of a polynucleotide construct comprising a sequence encoding at least a part of the active agent, with the composition comprising at least one active agent, wherein the antibody binds to the active agent, and b) determining the presence or absence of extraneous agents in the composition subsequent to step a). Furthermore, the invention specifies a process for producing a pharmaceutical composition by carrying out said method, to the use of a polynucleotide construct for testing the presence or absence of the active agent or of any extraneous or infectious agent in a composition to be tested. The present invention also relates to particular polynucleotides and polynucleotide constructs as useful substances in the field of influenza vaccines, as well as non-human organisms, transgenic animals or microorganisms containing the polynucleotides and/or polynucleotide constructs. The present invention is also directed to kit of parts.