Questions and answers for biological medicinal products

This question and answer page is developed and maintained by the CHMP Biologics Working Party (BWP) and provides agreed positions by the Biologics Working Party position on issues that can be subject to different interpretation or require clarification, typically arising from discussions or correspondence during assessment procedures of biological human medicinal products.

In order to obtain information on a topic, please click on the topics/questions. Please note that this page has been produced to provide transparency and additional information, and should be read in conjunction with the European Pharmacopoeia, CHMP guidelines on quality and other guidance documents.

Reprocessing (3.2.S.2.2, 3.2.P.3.3)

Raw materials and media components (3.2.S.2.3)

Method identification numbers (3.2.S.4.1, 3.2.P.5.1)

Process validation, removal of process related impurities, process related impurities testing (3.2.S.2.5, 3.2.P.3.5)

Host cell proteins testing, drug substance specification (3.2.S.3.2, 3.2.S.4.1, 3.2.S.4.5)

Biosimilar medicinal products: characterization, side-by-side comparison, specification, biosimilarity, analytical comparability (3.2.S, 3.2.S.3.1, 3.2.S.4.1, 3.2.P.5.1, 3.2.R)

Monoclonal antibodies specification, ADCC activity (3.2.S.4.1, 3.2.P.5.1)

Polysorbate testing in finished product specification (3.2.P.5)

Low Endotoxin Recovery, Endotoxin masking effect (3.2.P.5.3)

Non-novel excipients manufactured using recombinant technology (3.2.P.4, 3.2.A.3)


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