Expertise in CDC Characterisation Strategies
Of the numerous effector function strategies that are employed to characterise biosimilars, a CDC assessment is probably the most simplistic as the number of required assay formats is reduced and those that are employed are less technically demanding than ADCC and ADCP. However, CDC activity of biosimimlar is still significantly influenced by certain product attributes that can vary between a biosimilar and the reference innovator product and it is critical that both C1q binding assays and functional cell based CDC assays demonstrate sufficient sensitive to these known product attributes and behave, together, as orthogonal methods.
Our experts are industry leaders in the understanding of the requirements for effector function characterisation having worked with a range of different biosimilar molecules that demonstrate a diverse range of similarity relative to the reference innovator product. With a wide portfolio of assays for different biosimilar molecules, we can help define a successful CDC characterisation strategy for your biosimilar and perform the required experiments.
Our CDC characterisation services include C1q binding assays, functional cell based methods using novel cell lines coupled with capabilities to conduct a diverse range of investigatory CDC assay formats for the following molecules:
Adalimumab (Humira); Bevacizumab (Avastin); Denosumab (Prolia);
Denosumab (Prolia); Etanercept (Enbrel); Golimumab (Simponi);
Infliximab (Remicade); Obinutuzumab (Gazyva); Pertuzumab (Perjeta);
Rituximab (Rituxan/MabThera); Tocilizumab (Actemra); Ipilimumab (Yervoy);
Trastuzumab (Herceptin) and Ustekinumab (Stelara)
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