Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Concept Videos

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

Do we worry too much about polysorbate degradation? An industry-wide perspective with real-life case studies.

Journal of pharmaceutical sciences·2026
Same author

Development of a Raman Model for Continuous Monitoring of Detergent Viral Inactivation.

Biotechnology and bioengineering·2025
Same author

Sanguinarine Inhibits Cell Growth in EBV-Positive Diffuse Large B-Cell Lymphoma.

Archivum immunologiae et therapiae experimentalis·2025
Same author

Compliance and regulatory considerations for the implementation of the multi-attribute-method by mass spectrometry in a quality control laboratory.

European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V·2023
Same author

Development of UPLC-UV-ELSD Method for Fatty Acid Profiling in Polysorbate 80 and Confirmation of the Presence of Conjugated Fatty Acids by Mass Spectrometry, UV Absorbance and Proton Nuclear Magnetic Resonance Spectroscopy.

Journal of pharmaceutical sciences·2023
Same author

Technical considerations for the implementation of the multi-attribute-method by mass spectrometry in a quality control laboratory.

European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V·2023

Related Experiment Video

Updated: Apr 25, 2026

Author Spotlight: Detecting Low-Abundant Host Cell Proteins in Drug Products Using Enrichment Beads and Limited Digestion
09:45

Author Spotlight: Detecting Low-Abundant Host Cell Proteins in Drug Products Using Enrichment Beads and Limited Digestion

Published on: January 19, 2024

2.8K

Strategies for removing two "problematic" host cell proteins, using an "end-to-end" approach.

Greg Evangelist1, Chris Kwiatkowski2, Krishnakumar Malu2

  • 1Process Biochemistry, Biogen, Research Triangle Park, North Carolina, USA.

Biotechnology Progress
|April 24, 2026
PubMed
Summary

This study controlled problematic host cell proteins (HCPs) in monoclonal antibody manufacturing. Optimized upstream and downstream processes effectively reduced HCP levels to meet safety targets for biopharmaceuticals.

Keywords:
cell cultureheat shock protein 90 (HSP 90)host cell proteins (HCPs)perilipin‐4‐like (PLIN)transcriptomics (omics)

More Related Videos

Targeted Antibody Blocking by a Dual-Functional Conjugate of Antigenic Peptide and Fc-III Mimetics DCAF
09:39

Targeted Antibody Blocking by a Dual-Functional Conjugate of Antigenic Peptide and Fc-III Mimetics DCAF

Published on: September 17, 2019

6.1K
Targeting Cysteine Thiols for in Vitro Site-specific Glycosylation of Recombinant Proteins
11:25

Targeting Cysteine Thiols for in Vitro Site-specific Glycosylation of Recombinant Proteins

Published on: October 4, 2017

6.0K

Related Experiment Videos

Last Updated: Apr 25, 2026

Author Spotlight: Detecting Low-Abundant Host Cell Proteins in Drug Products Using Enrichment Beads and Limited Digestion
09:45

Author Spotlight: Detecting Low-Abundant Host Cell Proteins in Drug Products Using Enrichment Beads and Limited Digestion

Published on: January 19, 2024

2.8K
Targeted Antibody Blocking by a Dual-Functional Conjugate of Antigenic Peptide and Fc-III Mimetics DCAF
09:39

Targeted Antibody Blocking by a Dual-Functional Conjugate of Antigenic Peptide and Fc-III Mimetics DCAF

Published on: September 17, 2019

6.1K
Targeting Cysteine Thiols for in Vitro Site-specific Glycosylation of Recombinant Proteins
11:25

Targeting Cysteine Thiols for in Vitro Site-specific Glycosylation of Recombinant Proteins

Published on: October 4, 2017

6.0K

Area of Science:

  • Biopharmaceutical Manufacturing
  • Protein Chemistry
  • Process Development

Background:

  • Host cell proteins (HCPs) are critical impurities in recombinant protein biopharmaceuticals, potentially affecting product safety and efficacy.
  • Two specific HCPs, heat shock protein 90 beta and perilipin-4-like, were identified in a Chinese hamster ovary (CHO) cell line during Immunoglobulin G subclass 1 (IgG1) monoclonal antibody process development.
  • A risk assessment identified these HCPs as "problematic," necessitating the establishment of target removal levels.

Purpose of the Study:

  • To explore conditions that minimize deviations from the platform process while effectively controlling problematic HCP levels.
  • To investigate upstream and downstream process modifications for reducing specific HCPs in an IgG1 monoclonal antibody process.
  • To establish target levels for problematic HCPs to guide removal strategies.

Main Methods:

  • An end-to-end approach was employed, evaluating downstream purification steps such as Protein A washes, polishing chromatography, and depth filtration.
  • Upstream process parameters, including temperature shifts and modulation of iron and citrate concentrations, were investigated.
  • Risk assessment included HCP identification, homology analysis with human proteins, and review of non-clinical and clinical data.

Main Results:

  • Optimized upstream and downstream conditions were identified that effectively reduced the levels of the two problematic HCP species.
  • The study demonstrated the successful implementation of process modifications to meet drug substance targets for HCP removal.
  • Both upstream and downstream levers contributed to the effective control of heat shock protein 90 beta and perilipin-4-like.

Conclusions:

  • The developed strategies effectively control problematic host cell proteins in recombinant monoclonal antibody production.
  • Optimizing both upstream and downstream processes is crucial for managing critical impurities like HCPs.
  • This study provides a framework for controlling specific HCPs to ensure biopharmaceutical safety and efficacy.