Study of Protein Adsorption During Sterile Filtration of Protein Formulations by ILC

被引:5
|
作者
Haindl, Susanne Maria Hilda [1 ,2 ]
Doppleb, Olivia [1 ,3 ]
Foerster, Lucas [1 ,4 ]
Wraage, Sophia [1 ]
Reiche, Annette [1 ]
机构
[1] Sartorius Stedim Biotech GmbH, August Spindler Str 11, D-37089 Gottingen, Germany
[2] Leibniz Univ Hannover, Inst Tech Chem, Callinstr 5, D-30167 Hannover, Germany
[3] Tech Univ Clausthal, Inst Phys Chem, Arnold Sommerfeld Str 4, D-38678 Clausthal Zellerfeld, Germany
[4] Georg August Univ Gottingen, Inst Organ & Biomol Chem, Tammannstr 2, D-37077 Gottingen, Germany
关键词
Inverse liquid chromatography; Protein adsorption; Sterile filtration; MEMBRANE; SURFACES; PH;
D O I
10.1002/cite.201900185
中图分类号
TQ [化学工业];
学科分类号
0817 ;
摘要
Protein adsorption is usually regarded as the main reason for filter fouling in sterile filtration of protein formulations. To achieve a better insight into this phenomenon, protein adsorption was studied during filtration of stabilized bovine serum albumin (BSA) and gamma-globulin formulations through 0.2-mu m microfilter membranes by inverse liquid chromatography (ILC). Adsorption processes can be studied with this method by measurement of breakthrough curves. The change of the concentration in the fluid phase is measured with high accuracy by an inline UV-detector.
引用
收藏
页码:1109 / 1121
页数:13
相关论文
共 50 条
  • [1] Sterile Filtration of Highly Concentrated Protein Formulations: Impact of Protein Concentration, Formulation Composition, and Filter Material
    Allmendinger, Andrea
    Mueller, Robert
    Huwyler, Joerg
    Mahler, Hanns-Christian
    Fischer, Stefan
    JOURNAL OF PHARMACEUTICAL SCIENCES, 2015, 104 (10) : 3319 - 3329
  • [2] Modification of a PES microfiltration membrane to enhance sterile filtration by inhibiting protein adsorption
    Yun, Kang Hee
    Sharma, Komal
    Kim, Hyun Uk
    Bae, Tae-Hyun
    JOURNAL OF INDUSTRIAL AND ENGINEERING CHEMISTRY, 2023, 123 : 311 - 319
  • [3] Study of protein adsorption effects on crossflow filtration using BSA and milk protein
    Colton, RH
    Pahl, I
    Ottaviano, LE
    Bodeutsch, T
    Meyeroltmanns, F
    PDA JOURNAL OF PHARMACEUTICAL SCIENCE AND TECHNOLOGY, 2002, 56 (01) : 20 - 30
  • [4] Heat stable and intrinsically sterile liquid protein formulations
    Lawanprasert, Atip
    Singh, Harminder
    Pimcharoen, Sopida
    Vargas, Mariangely Gonzalez
    Dewan, Arshiya
    Kirimanjeswara, Girish S.
    Medina, Scott H.
    NATURE COMMUNICATIONS, 2024, 15 (01)
  • [5] Sterile filtration of NanoCrystal(TM) drug formulations
    Zheng, JY
    Bosch, HW
    DRUG DEVELOPMENT AND INDUSTRIAL PHARMACY, 1997, 23 (11) : 1087 - 1093
  • [6] Optimizing PES microfiltration membranes for sterile filtration: A comparative study of polydopamine coating in acidic and basic conditions to minimize protein adsorption
    Yun, Kang Hee
    Sim, Seungbo
    Hong, Hee Soo
    Jeong, Ki Jun
    Bae, Tae-Hyun
    JOURNAL OF MEMBRANE SCIENCE, 2025, 713
  • [7] Filtration of protein-based solutions with ceramic ultrafiltration membrane. Study of selectivity, adsorption, and protein denaturation
    Miron, Simona M.
    Dutournie, Patrick
    Thabet, Kawther
    Ponche, Arnaud
    COMPTES RENDUS CHIMIE, 2019, 22 (2-3) : 198 - 205
  • [8] The importance of interfaces in protein drug delivery - why is protein adsorption of interest in pharmaceutical formulations?
    Pinholt, Charlotte
    Hartvig, Rune Andersen
    Medlicott, Natalie J.
    Jorgensen, Lene
    EXPERT OPINION ON DRUG DELIVERY, 2011, 8 (07) : 949 - 964
  • [9] PROTEIN ADSORPTION AND TRAPPING DURING STEADY AND PULSED FLOW PLASMA CROSS-FLOW FILTRATION
    PHILP, JL
    JAFFRIN, MY
    DING, LH
    JOURNAL OF MEMBRANE SCIENCE, 1994, 88 (2-3) : 197 - 209
  • [10] PROTEIN ADSORPTION BY ARTIFICIAL MEMBRANE MATERIALS UNDER FILTRATION CONDITIONS
    BIRK, HW
    KISTNER, A
    WIZEMANN, V
    SCHUTTERLE, G
    ARTIFICIAL ORGANS, 1995, 19 (05) : 411 - 415