
- BioPharm International-10-15-2016
- Volume 2016 eBook
- Issue 2
Seeking Accelerated Biosimilar Characterization
The authors describe the qualification of an assay with applications for investigating functional comparability of an originator and biosimilar drug.
The development of a biosimilar product requires extensive structural and functional characterization at many stages. At the functional level, pharmacologic activity should be evaluated by appropriate in-vitro and/or in-vivo assays in a comparative sense, to provide evidence that the activity and potency are similar, supporting data from structural characterization.
These in-vitro and in-vivo potency assays, however, can be expensive and time consuming, with readouts that are often far downstream of the initial drug/target interaction. Cell-based assays, with a readout proximal to the initial target, can be an attractive alternative. The authors describe the qualification of an assay with applications for investigating functional comparability of an originator and biosimilar drug.
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Articles in this issue
almost 9 years ago
Cell Line Quality Technologiesalmost 9 years ago
Investigation Effectiveness Drives Human Performance Excellencealmost 9 years ago
Data Integrity Challenges in Manufacturingalmost 9 years ago
Evaluating Technology and Innovation in Biopharmaceutical Manufacturingalmost 9 years ago
Plant-Made Pharmaceuticals—Accelerating Drug Development Globallyalmost 9 years ago
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