EMA: Q&A on Biological Medicinal Products
The EMA has published 14 questions and answers for biological products on its website. The CHMP Biologics Working Party developed the page that provides their agreed positions on issues that typically arise from discussions or correspondence during assessment procedures of biological human medicinal products.
The following topics are covered in detail:
- Reprocessing,
- Raw materials and media components,
- Method identification numbers
- Process validation, removal of process-related impurities, process-related impurities testing
- Host cell proteins testing, drug substance specification.
- Biosimilar medicinal products: characterization, side-by-side comparison, specification, biosimilarity, analytical comparability
- Monoclonal antibodies specification, ADCC activity
- Polysorbate testing in finished product specification
- Low Endotoxin Recovery, Endotoxin masking effect
Source:
EMA: Questions and answers for biological medicinal products
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