Product-specific methods emphasize analytical procedure selection, system suitability tests, and assay performance criteria to improve consistency across biologic and biosimilar quality attribute ...

Low-dose dissolution frequently demands reduced media volumes to keep early time-point concentrations above LOQ, and regulators may expect evaluation of higher-sensitivity analytics before lowering ...

Gene therapy represents one of the fastest growing biotherapeutics worldwide, with AAV at the forefront. This rapid growth is constantly challenging CMC approaches, from manufacturing through release ...