Janssen scientists involved in the successful transition from batch to continuous manufacturing (CM) for its anti-HIV product Prezista are forthright in their recognition of the role played by academia – especially Rutgers University – in addressing the technical and regulatory challenges.
The Rutgers team have been appearing alongside their Janssen collaborators at a series of conferences since FDA cleared the switch from batch to CM for the manufacture of Prezista 600 mg tablets via a prior approval supplement (PAS) in April 2016. Janssen’s was the second CM process cleared by FDA, following in the wake of the mid-2015 approval of Vertex’ tablet product Orkambi using CM. [See IPQ May 17, 2017 for more on the Vertex CM experience.]
Among the venues where the key CM players from Janssen and Rutgers have appeared together were the September 2016 ISPE Annual Meeting in Atlanta, Georgia, the February 2017 IFPAC conference in Bethesda, Maryland (MD), the March FDA/Product Quality Research Institute (PQRI) conference in Rockville, MD, and the April DIA CMC Workshop also held in Rockville, MD.
Director of GTS Solids Supply Chain Eric Sánchez, CMC Regulatory Affairs Director Jeff Kinzer and Associate Director Gilfredo Navarro are among those involved for Janssen who have been providing insights on the firm’s experience and learnings. The Janssen team have underscored the importance of leveraging relationships with both academia and FDA in their successful execution of CM.
At the ISPE Atlanta conference, Sánchez focused on the pivotal role that the Rutger’s-led Center for Structured Organic Particulate Systems (C-SOPS) has played in the CM development process for Janssen. Kinzer focused on the regulatory component of the CM equation and the contribution of the partnership with FDA.
Founded in 2006, C-SOPS is one of the Engineering Research Centers (ERC) funded by the U.S. government’s National Science Foundation (NSF). The mission of the ERC SOPS is to work with industry and FDA to modernize pharmaceutical formulation and manufacturing processes. As such, continuous manufacturing of oral solid products and related formulation issues have been a key center focal point. Partnering with Rutgers in C-SOPs are the New Jersey Institute of Technology, Purdue University and the University of Puerto Rico-Mayaguez (UPRM).