Firms should identify risks prior to inspection, make staff available during regulator visits, and respond promptly post-inspection when undergoing GMP site checks, says Ireland’s Health Products Regulatory Authority (HPRA).
Either the folks at Hospira, Celltrion, Samsung Biologics, Teva, Merck & Co and Quintiles are hopeless romantics investing in science for its own sake or, for them, the “debate” about the potential of biosimilars has already been resolved.
ADC Biotechnology (ADC Bio) has secured a development grant for a new antibody drug conjugate (ADC) manufacturing technology that, it says, can make drug production cheaper.
Pall Life Sciences has launched its Allegro 3D biocontainers, which have been designed to improve the performance of the company’s large-scale, single use manufacturing systems.
