title: In-use physicochemical and microbiological stability of biological parenteral products.
authors.affiliation: Margaret 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.
authors.forename: Margaret Speed
authors.initials: MS
authors.lastname: Ricci
authors.affiliation: Margaret 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.
authors.forename: Michelle
authors.initials: M
authors.lastname: Frazier
authors.affiliation: Margaret 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.
authors.forename: Jamie
authors.initials: J
authors.lastname: Moore
authors.affiliation: Margaret 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.
authors.forename: Mary
authors.initials: M
authors.lastname: Cromwell
authors.affiliation: Margaret 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.
authors.forename: William J
authors.initials: WJ
authors.lastname: Galush
authors.affiliation: Margaret 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.
authors.forename: Ankit R
authors.initials: AR
authors.lastname: Patel
authors.affiliation: Margaret 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.
authors.forename: Michael
authors.initials: M
authors.lastname: Adler
authors.affiliation: Margaret 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.
authors.forename: Ulrike
authors.initials: U
authors.lastname: Altenburger
authors.affiliation: Margaret 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.
authors.forename: Ulla
authors.initials: U
authors.lastname: Grauschopf
authors.affiliation: Margaret 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.
authors.forename: Pierre
authors.initials: P
authors.lastname: Goldbach
authors.affiliation: Margaret 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.
authors.forename: Jonas L
authors.initials: JL
authors.lastname: Fast
authors.affiliation: Margaret 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.
authors.forename: Irene
authors.initials: I
authors.lastname: Krämer
authors.affiliation: Margaret 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. hanns-christian.mahler@roche.com.
authors.forename: Hanns-Christian
authors.initials: HC
authors.lastname: Mahler
mesh_terms: D001419:Bacteria; D001688:Biological Products / Q000737:chemistry; D002626:Chemistry, Pharmaceutical; D004339:Drug Compounding; D004340:Drug Contamination; D004349:Drug Packaging / Q000592:standards; D004355:Drug Stability; D006801:Humans; D007263:Infusions, Parenteral / Q000592:standards*; D019999:Pharmaceutical Solutions / Q000737:chemistry*; D011506:Proteins / Q000032:analysis
chemical_list: D001688:Biological Products; D019999:Pharmaceutical Solutions; D011506:Proteins