iBB

Removal of genotoxic impurities (GTI) from active pharmaceutical ingredients (API) is mandatory to deliver safe medicines, but to achieve GTI at ultra-low limit (<1.5 µg/day) implies significative API loss. A recent paper published in the journal Membranes by Flávio Ferreira, Leonor Resina, Teresa Esteves and Frederico Ferreira from BERG-iBB, propose the use of a mathematical model to predict whether adsorption or membrane process is suitable for API purification. Moreover, in cases where none of them have an acceptable API loss, a hybrid process combining both processes was developed, reducing API loss from 24.76% to 9.76%. Furthermore, economic and environmental analyses were also performed.