This survey covers the challenges of working with ultra-high concentration formulations, including; low dose volume products, viscosity aspects related to manufacturing and delivery, manufacturing and filling, automated screening, analytical challenges, osmolality...
Host cell proteins (HCPs) are process-related impurities that may copurify with biopharmaceutical drug products. Within this class of impurities there are some that are more problematic. These problematic HCPs can be considered high-risk and can include those that are...
Since its start in 2013, the Formulation Point Share has been busy. In February 2018 It published, An inter-company perspective on biopharmaceutical drug product robustness studies, in the Journal of Pharmaceutical Sciences which was viewed online over 1,000 times in...
