Janssen Pharmaceutical R&D, LLC
Kristopher A. Barnthouse, PhD, has over 21 years of experience in development of early stage and commercial manufacturing processes for protein-based therapeutics and recombinant vaccines. He is currently serving as Scientific Director, Pharmaceutical Development & Manufacturing Sciences at Janssen R&D, LLC. During his tenure with Janssen, he has worked on the development and lifecycle management of seven marketed products, including ReoPro, Remicade, Simponi, Stelara, Sylvant, Darzalex, and Tremfya and other investigational products. Prior to joining Janssen, Kris spent 4 years at GlaxoSmithKline supporting the development of Nucala as well as other products in clinical development. Kris has expertise in the technical fields of microbial and mammalian expression systems, perfusion and fed-batch cell culture technology, recovery and purification, process modelling, and technology transfer, as well as regulatory topics including quality by design (QbD), quality risk management, control strategy development, and manufacturing process validation. He was awarded the Johnson Medal in 2012 for the development of Johnson & Johnson’s first biological combination product.
Kris has been active in the scientific and regulatory community for biological products and is an active member of the CASSS CMC Strategy Forum North America Committee and the BIO Manufacturing, Quality, and Distribution team. He is also a member of the BIOT division of the American Chemical Society and has served in various organizational roles for national meetings. Kris has also served as an industry delegate to the EMA Expert Workshop on Process Validation, the USP/BIO roundtable for the development of standards for biologicals production, is a co-author of an EBE position paper on platform manufacturing of antibody products and has participated in the QbD pilot program with FDA. He earned his MS and PhD degrees in Chemical Engineering from Rensselaer Polytechnic Institute, and his BS degree in Chemical Engineering from the University of Cincinnati. Kris also serves as Adjunct Professor in the Temple University School of Pharmacy, Quality Assurance and Regulatory Affairs program.