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Whether you are in clinical trials and looking to scale-up, need a particular type of technology, or...
By Evan Pasenello, Account Manager, Biologics at Abb Vie Contract Manufacturing and Daniel Sayut, Senior Scientist I at Abb Vie Bioresearch Center While traditional small molecule drug products usually consist of pure chemical substances that are easily analyzed after manufacture, biologics such as monoclonal antibodies (m Abs) are much more complex.
Not only does this make their production considerably more challenging, but it also means that identification of clinically active components is extremely difficult.
Because of this, biologics are instead defined by their manufacturing process, which requires complete understanding through formal process characterization..
Typically carried out during the late stages of drug development, following phase II clinical trials, process characterization is an essential component of process validation.
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