Author Archives: Hervé Broly

Seamless Transition from R&D to Manufacturing

Fast and cheap: These criteria are becoming ever more urgent drivers for manufacturers of biologics, faced with increased scrutiny on the costs of developing novel drugs, the lengthy timelines for delivering these drugs to patients, and the tightening competition to capitalize on new targets. The challenge for manufacturers is further heightened by the expectations to deliver on quality as well. Although development and production of molecules such as monoclonal antibodies (MAbs) have greatly benefited from the “platformization” of core technologies…

Robustness of Parvovirus–Retentive Membranes and Implications for Virus Clearance Validation Requirements

    Generic validation is conceivable only through a thorough understanding of the parameters affecting the performance of a process step. In this paper, we provide a detailed example demonstrating the robustness of a virus filtration step. As a first step towards the establishment of a generic validation package for a monoclonal antibody, the robustness of clearance of PP7 across the ViroSart CPV filter was evaluated by changing several critical operational parameters using a simple one-off experimental design. Two different…