5.6.1.5
Definition by production process

Antibodies can be defined by the process of their production, i.e. either by the immunisation protocol of a non-human animal with a well-characterised antigen or by the specific cell line used to produce them; for more details see F-IV, 4.12.

However, such a product-by-process definition, based on the immunisation by an antigen comprising a sequence less than 100% identical to a defined sequence does not fulfil the requirements of Art. 84 because the use of variants renders the scope of the antibodies obtained by the immunisation process unclear.

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