In-use physicochemical and microbiological stability of biological parenteral products

Margaret Speed Ricci¹, Michelle Frazier¹, Jamie Moore¹+10

• ¹Margaret Speed Ricci, Ph.D., is Director of Process Development, Drug Product Development, Genentech, South San Francisco, CA. Michelle Frazier, M.S., is Director, Regulatory Affairs, Amgen, Thousand Oaks, CA. Jamie Moore, Ph.D., is Director, Early-Stage Pharmaceutical Development; Mary Cromwell, Ph.D., is Director, Late-Stage Pharmaceutical Development; William J. Galush, Ph.D., is Scientist, Late-Stage Pharmaceutical Development; and Ankit R. Patel, Ph.D., is Scientist, Early-Stage Pharmaceutical Development, Pharmaceutical Development, Pharma Technical Development Biologics U.S., Genentech, South San Francisco, CA. Michael Adler, Ph.D., is Head, Late-Stage Pharmaceutical and Processing Development; Ulrike Altenburger, Ph.D., is Head, Early-Stage Pharmaceutical Development and GLP Tox Supplies; Ulla Grauschopf, Ph.D., is Senior Group Leader, Late-Stage Pharmaceutical and Processing Development; Pierre Goldbach, Ph.D., is Senior Group Leader, Late-Stage Pharmaceutical and Processing Development; and Jonas L. Fast, Ph.D., is Group Leader, Early-Stage Pharmaceutical Development and GLP Tox Supplies, Pharmaceutical Development and Supplies, Pharma Technical Development Biologics EU, F. Hoffmann-LaRoche Ltd., Basel, Switzerland. Irene Krämer, Ph.D., is Director, Pharmacy Department, Medical Center of Johannes Gutenberg-University Hospital, Mainz, Germany, and Professor of Clinical Pharmacy, Pharmacy School of Johannes Gutenberg-University, Mainz. Hanns-Christian Mahler, Ph.D., is Head, Pharmaceutical Development and Supplies, Pharma Technical Development Biologics EU, F. Hoffmann-LaRoche Ltd.+1