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Despite careful testing of starting materials and in-process intermediates, there is still a risk that a virus could enter the manufacturing process undetected. Here, we review the studies which involve scaling down individual process steps, and for each step, spiking virus into the specific process intermediate, performing the process step and measuring the virus remaining after the process step.
What was once a check-the-box procedure in standard stability testing now requires a deeper understanding of the molecule, how it behaves, and, most importantly, what effect it has on the patient.
Combatting the challenges of developing and manufacturing ADCs requires robust product characterization throughout all phases of development.
Because characterization and comparison of originator and biosimilar candidate mAbs is challenging due to their complex and variable structures, a range of analytical techniques should be employed.
The relationship between physicochemical profile and biological activity — and how this relationship affects clinical performance — is key to making informed decisions, accelerating development, and reducing risk.