Zobrazeno 1 - 3
of 3
pro vyhledávání: '"Jennifer Halley"'
Autor:
Edward Koepf, Sarah L Demmon, Marisa K. Joubert, Swapnil Bhargava, Phillip Smith, Philip Tsai, Nomalie Jaya, Doreen Ciolek, Melody Trexler-Schmidt, Jennifer Halley
Publikováno v:
Biologicals. 67:9-20
Identification of Critical Quality Attributes (CQAs) and subsequent characterization in process development studies are the key elements of quality by design (QbD) for biopharmaceutical products. Since the inception of ICH Q8R2, several articles have
Autor:
Wasfi Al-Azzam, Sambit R. Kar, Niclas Chiang Tan, Zhenyu Gu, Zoran Sosic, Crystal Cicchino, Alexandru C. Lazar, Paul Weisbach, Yite Robert Chou, Liqiang Lisa Zhou, Jennifer Halley, Santosh V. Thakkar, Smith John M, Magdalena Gauden, Elaine S.E. Stokes, Min Huang, Promod Mehndiratta, Vikas K. Sharma, Stephane Cornen
Publikováno v:
Journal of Pharmaceutical Sciences. 109:6-21
The BioPhorum Development Group is an industry-wide consortium enabling networking and sharing of common practices for the development of biopharmaceuticals. Forced degradation studies (FDSs) are often used in biotherapeutic development to assess cri
Publikováno v:
Journal of Chromatography. a
Highlights • IgG aggregation at low pH follows pH-dependent exponential decay kinetics. • IgG aggregation behaviour is influenced by a protein A chromatography step. • The mechanism of aggregation appears to be accelerated by the separation pro