Beyond OEB5: Is OEB6 really the next standard for high-potency pharma?

As OEB6 increasingly appears in HPAPI and ADC manufacturing, the key question is whether pharmaceutical pipelines actually require a new exposure band — or whether the label is becoming commercial shorthand for ultra-high containment. The evidence suggests there is a more nuanced shift underway. As OEB6 increasingly appears in HPAPI and ADC manufacturing, the key question is whether pharmaceutical pipelines actually require a new exposure band — or whether the label is becoming commercial shorthand for ultra-high containment. The evidence suggests there is a more nuanced shift underway. Many CDMOs are getting to grips with OEB6, which has yet to…

Source: Clinical Trials Arena