BioPharmaSpec provides a full range of biosimilar comparability, biosimilarity and characterization services to support the development of your biosimilar.
The EMA guideline EMA/CHMP/BWP/247713/2012 “Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues (revision 1)” states that the biosimilar product should be characterized thoroughly and shown to be comparable to a reference medicinal product.
BioPharmaSpec achieves this though biosimilar comparability, biosimilarity and characterization studies of both the biosimilar and the innovator product. These studies cover the following points raised in various biosimilar guidelines:
- The target amino acid sequence of the biosimilar should be confirmed and shown to be the same as the reference medicinal product.
- The N- and C-terminal amino acid sequences, free sulfhydral groups and disulfide bridges should be compared.
- Any modifications/truncations should be quantified.
- The presence and extent of post-translational modifications (e.g. glycosylation, oxidation, deamidation, truncation) should be appropriately characterized.
- If present, carbohydrate structures should be thoroughly compared, including the overall glycan profile, site- specific glycosylation patterns and also site occupancy.