The Effect of Formulation Excipients on Protein Stability and Aerosol Performance of Spray-Dried Powders of a Recombinant Humanized Anti-IgE Monoclonal Antibody1

被引:0
|
作者
James D. Andya
Yuh-Fun Maa
Henry R. Costantino
Phuong-Anh Nguyen
Nancy Dasovich
Theresa D. Sweeney
Chung C. Hsu
Steven J. Shire
机构
[1] Genentech,Pharmaceutical Research and Development
[2] Inc.,undefined
[3] Powderject Technologies,undefined
[4] Alkermes,undefined
[5] Inc.,undefined
来源
Pharmaceutical Research | 1999年 / 16卷
关键词
aggregation; glycation; fine particle fraction; protein formulation; protein stability; spray drying;
D O I
暂无
中图分类号
学科分类号
摘要
Purpose. To study the effect of trehalose, lactose, and mannitol on the biochemical stability and aerosol performance of spray-dried powders of an anti-IgE humanized monoclonal antibody.
引用
收藏
页码:350 / 358
页数:8
相关论文
共 3 条
  • [1] The effect of formulation excipients on protein stability and aerosol performance of spray-dried powders of a recombinant humanized anti-IgE monoclonal antibody
    Andya, JD
    Maa, YF
    Costantino, HR
    Nguyen, PA
    Dasovich, N
    Sweeney, TD
    Hsu, CC
    Shire, SJ
    PHARMACEUTICAL RESEARCH, 1999, 16 (03) : 350 - 358
  • [2] Effect of mannitol crystallization on the stability and aerosol performance of a spray-dried pharmaceutical protein, recombinant humanized anti-IgE monoclonal antibody
    Costantino, HR
    Andya, JD
    Nguyen, PA
    Dasovich, N
    Sweeney, TD
    Shire, SJ
    Hsu, CC
    Maa, YF
    JOURNAL OF PHARMACEUTICAL SCIENCES, 1998, 87 (11) : 1406 - 1411
  • [3] On the role of excipients in biopharmaceuticals manufacture: Modelling-guided formulation identifies the protective effect of arginine hydrochloride excipient on spray-dried Olipudase alfa recombinant protein
    Sharma, Ashutosh
    Cazade, Pierre
    Khamar, Dikshitkumar
    Hayden, Ambrose
    Thompson, Damien
    Hughes, Helen
    INTERNATIONAL JOURNAL OF PHARMACEUTICS, 2024, 662