Development of a Hydrodynamic Cleaning Cycle for Ultrafiltration/Diafiltration Processes Used for Monoclonal Antibody Formulation

Youngbin Baek, Deyu Yang, Andrew Zydney

Research output: Contribution to journalArticle

Abstract

Ultrafiltration/diafiltration (UFDF) processes are used for final formulation of high value biotherapeutics like monoclonal antibodies. Membrane fouling and cleaning are both critical factors governing the performance of these processes, but there is very limited data on either of these phenomena, particularly at the high monoclonal antibody concentrations used in current UFDF systems. The objective of this study was to compare the effectiveness of different cleaning regimens for composite regenerated cellulose membranes in Pellicon 3 tangential flow filtration cassettes after UFDF of a monoclonal antibody product. The water permeability after UFDF was 20 ± 5% smaller than the clean membrane permeability due to fouling. Membranes could be successfully cleaned with 0.5 N NaOH, but this caused an increase in permeability and a loss in solute rejection due to an opening of the membrane pores. Cleaning with DI water was not very effective under normal flow conditions but provided very good recovery of water permeability when the flow was into the retentate exit port and out through the feed port, without any damage to the membrane as seen with NaOH. These results demonstrate the potential of using a hydrodynamic cleaning cycle without any aggressive cleaning chemicals for antibody fouled membranes.

Original languageEnglish (US)
Pages (from-to)16110-16115
Number of pages6
JournalIndustrial and Engineering Chemistry Research
Volume57
Issue number47
DOIs
StatePublished - Nov 28 2018

Fingerprint

Monoclonal antibodies
Ultrafiltration
Cleaning
Hydrodynamics
Monoclonal Antibodies
Membranes
Water
Chemical cleaning
Membrane fouling
Fouling
Antibodies
Cellulose
Recovery
Composite materials

All Science Journal Classification (ASJC) codes

  • Chemistry(all)
  • Chemical Engineering(all)
  • Industrial and Manufacturing Engineering

Cite this

@article{eee33720b87e47b3844867093d28971c,
title = "Development of a Hydrodynamic Cleaning Cycle for Ultrafiltration/Diafiltration Processes Used for Monoclonal Antibody Formulation",
abstract = "Ultrafiltration/diafiltration (UFDF) processes are used for final formulation of high value biotherapeutics like monoclonal antibodies. Membrane fouling and cleaning are both critical factors governing the performance of these processes, but there is very limited data on either of these phenomena, particularly at the high monoclonal antibody concentrations used in current UFDF systems. The objective of this study was to compare the effectiveness of different cleaning regimens for composite regenerated cellulose membranes in Pellicon 3 tangential flow filtration cassettes after UFDF of a monoclonal antibody product. The water permeability after UFDF was 20 ± 5{\%} smaller than the clean membrane permeability due to fouling. Membranes could be successfully cleaned with 0.5 N NaOH, but this caused an increase in permeability and a loss in solute rejection due to an opening of the membrane pores. Cleaning with DI water was not very effective under normal flow conditions but provided very good recovery of water permeability when the flow was into the retentate exit port and out through the feed port, without any damage to the membrane as seen with NaOH. These results demonstrate the potential of using a hydrodynamic cleaning cycle without any aggressive cleaning chemicals for antibody fouled membranes.",
author = "Youngbin Baek and Deyu Yang and Andrew Zydney",
year = "2018",
month = "11",
day = "28",
doi = "10.1021/acs.iecr.8b02608",
language = "English (US)",
volume = "57",
pages = "16110--16115",
journal = "Industrial and Engineering Chemistry Research",
issn = "0888-5885",
publisher = "American Chemical Society",
number = "47",

}

Development of a Hydrodynamic Cleaning Cycle for Ultrafiltration/Diafiltration Processes Used for Monoclonal Antibody Formulation. / Baek, Youngbin; Yang, Deyu; Zydney, Andrew.

In: Industrial and Engineering Chemistry Research, Vol. 57, No. 47, 28.11.2018, p. 16110-16115.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Development of a Hydrodynamic Cleaning Cycle for Ultrafiltration/Diafiltration Processes Used for Monoclonal Antibody Formulation

AU - Baek, Youngbin

AU - Yang, Deyu

AU - Zydney, Andrew

PY - 2018/11/28

Y1 - 2018/11/28

N2 - Ultrafiltration/diafiltration (UFDF) processes are used for final formulation of high value biotherapeutics like monoclonal antibodies. Membrane fouling and cleaning are both critical factors governing the performance of these processes, but there is very limited data on either of these phenomena, particularly at the high monoclonal antibody concentrations used in current UFDF systems. The objective of this study was to compare the effectiveness of different cleaning regimens for composite regenerated cellulose membranes in Pellicon 3 tangential flow filtration cassettes after UFDF of a monoclonal antibody product. The water permeability after UFDF was 20 ± 5% smaller than the clean membrane permeability due to fouling. Membranes could be successfully cleaned with 0.5 N NaOH, but this caused an increase in permeability and a loss in solute rejection due to an opening of the membrane pores. Cleaning with DI water was not very effective under normal flow conditions but provided very good recovery of water permeability when the flow was into the retentate exit port and out through the feed port, without any damage to the membrane as seen with NaOH. These results demonstrate the potential of using a hydrodynamic cleaning cycle without any aggressive cleaning chemicals for antibody fouled membranes.

AB - Ultrafiltration/diafiltration (UFDF) processes are used for final formulation of high value biotherapeutics like monoclonal antibodies. Membrane fouling and cleaning are both critical factors governing the performance of these processes, but there is very limited data on either of these phenomena, particularly at the high monoclonal antibody concentrations used in current UFDF systems. The objective of this study was to compare the effectiveness of different cleaning regimens for composite regenerated cellulose membranes in Pellicon 3 tangential flow filtration cassettes after UFDF of a monoclonal antibody product. The water permeability after UFDF was 20 ± 5% smaller than the clean membrane permeability due to fouling. Membranes could be successfully cleaned with 0.5 N NaOH, but this caused an increase in permeability and a loss in solute rejection due to an opening of the membrane pores. Cleaning with DI water was not very effective under normal flow conditions but provided very good recovery of water permeability when the flow was into the retentate exit port and out through the feed port, without any damage to the membrane as seen with NaOH. These results demonstrate the potential of using a hydrodynamic cleaning cycle without any aggressive cleaning chemicals for antibody fouled membranes.

UR - http://www.scopus.com/inward/record.url?scp=85051101799&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85051101799&partnerID=8YFLogxK

U2 - 10.1021/acs.iecr.8b02608

DO - 10.1021/acs.iecr.8b02608

M3 - Article

AN - SCOPUS:85051101799

VL - 57

SP - 16110

EP - 16115

JO - Industrial and Engineering Chemistry Research

JF - Industrial and Engineering Chemistry Research

SN - 0888-5885

IS - 47

ER -