Zobrazeno 1 - 3
of 3
pro vyhledávání: '"Gyöngyi Gratzl"'
Autor:
Michael T. Boyne, Hugh D. Conlon, Henriette Kuehne, Gyöngyi Gratzl, Todd Coffey, Hiten J. Gutka, Richard Burdick, Chi-Ting Huang
Publikováno v:
The AAPS Journal. 19:4-14
Protein therapeutics have unique critical quality attributes (CQAs) that define their purity, potency, and safety. The analytical methods used to assess CQAs must be able to distinguish clinically meaningful differences in comparator products, and th
Autor:
Pearle Torralba, Moheb Nasr, Elaine Gray, Roger L. Williams, Gyöngyi Gratzl, Edward K. Chess, Kristian Johansen, David A. Keire, Ali Al-Hakim, Anita Y. Szajek, Janet Woodcock, Christian Viskov, Jian Liu, Robert J. Linhardt, Zachary Shriver, Barbara Mulloy, Tina S. Morris, Wesley E. Workman
Publikováno v:
Nature Biotechnology. 34:625-630
The contamination of the widely used lifesaving anticoagulant drug heparin in 2007 has drawn renewed attention to the challenges that are associated with the characterization, quality control and standardization of complex biological medicines from n
Autor:
David A. Keire, Manish Kumar, Gyöngyi Gratzl, Andreas Seidl, Hiten J. Gutka, Todd Coffey, Henriette Kuehne, Kristof Vandekerckhove
Publikováno v:
The AAPS Journal. 20
Leading regulatory agencies recommend biosimilar assessment to proceed in a stepwise fashion, starting with a detailed analytical comparison of the structural and functional properties of the proposed biosimilar and reference product. The degree of a