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

A comprehensive engineering strategy improves potency and manufacturability of a near pan-neutralizing antibody against HIV.

Structure (London, England : 1993)·2025
Same author

A comprehensive engineering strategy improves potency and manufacturability of a near pan-neutralizing antibody against HIV.

bioRxiv : the preprint server for biology·2024
Same author

A candidate antibody drug for prevention of malaria.

Nature medicine·2024
Same author

The Development of a Novel Aflibercept Formulation for Ocular Delivery.

Journal of pharmaceutical sciences·2023
Same author

Roadmap for Drug Product Development and Manufacturing of Biologics.

Journal of pharmaceutical sciences·2023
Same author

Evaluation of Crystal Zenith Microtiter Plates for High-Throughput Formulation Screening.

Journal of pharmaceutical sciences·2019

Related Experiment Video

Updated: Jan 4, 2026

Studying Protein Import into Chloroplasts Using Protoplasts
06:29

Studying Protein Import into Chloroplasts Using Protoplasts

Published on: December 10, 2018

10.3K

Shocking Data on Parcel Shipments of Protein Solutions.

Christine Siska1, Paul Harber2, Bruce A Kerwin1

  • 1Just Biotherapeutics, Inc., Seattle, Washington 98110.

Journal of Pharmaceutical Sciences
|November 6, 2019
PubMed
Summary

Shipping liquid drug formulations without polysorbate increased particle formation. Polysorbate stabilized formulations against shock and vibration during shipping, crucial for biologic drug stability.

Keywords:
antibodybiotechnologydevelopabilityformulationhigh concentrationphysical stabilityprotein aggregationprotein foldingprotein formulationprotein structure

More Related Videos

LERLIC-MS/MS for In-depth Characterization and Quantification of Glutamine and Asparagine Deamidation in Shotgun Proteomics
08:01

LERLIC-MS/MS for In-depth Characterization and Quantification of Glutamine and Asparagine Deamidation in Shotgun Proteomics

Published on: April 9, 2017

8.5K
Microsampling in Targeted Mass Spectrometry-Based Protein Analysis of Low-Abundance Proteins
10:21

Microsampling in Targeted Mass Spectrometry-Based Protein Analysis of Low-Abundance Proteins

Published on: January 13, 2023

2.8K

Related Experiment Videos

Last Updated: Jan 4, 2026

Studying Protein Import into Chloroplasts Using Protoplasts
06:29

Studying Protein Import into Chloroplasts Using Protoplasts

Published on: December 10, 2018

10.3K
LERLIC-MS/MS for In-depth Characterization and Quantification of Glutamine and Asparagine Deamidation in Shotgun Proteomics
08:01

LERLIC-MS/MS for In-depth Characterization and Quantification of Glutamine and Asparagine Deamidation in Shotgun Proteomics

Published on: April 9, 2017

8.5K
Microsampling in Targeted Mass Spectrometry-Based Protein Analysis of Low-Abundance Proteins
10:21

Microsampling in Targeted Mass Spectrometry-Based Protein Analysis of Low-Abundance Proteins

Published on: January 13, 2023

2.8K

Area of Science:

  • Pharmaceutical Sciences
  • Biopharmaceutical Stability
  • Logistics and Supply Chain

Background:

  • Biopharmaceutical liquid formulations require rigorous stability testing.
  • Shipping conditions can expose drugs to mechanical stress, impacting stability.
  • Understanding the effects of shock and vibration is critical for maintaining drug integrity.

Purpose of the Study:

  • To assess the physical stability of liquid formulations during simulated shipping.
  • To determine the impact of shock and vibration on particle formation in monoclonal antibody (mAb) formulations.
  • To evaluate the protective effect of polysorbate against shipping-induced instability.

Main Methods:

  • Parcel shipments were conducted between Seattle, WA, and Indianapolis, IN.
  • Data loggers recorded GPS, shock (8-36G), and temperature during transport.
  • Formulations with and without polysorbate were analyzed for submicron and visible particles post-shipment.
  • Controlled drop tests simulated specific shock events (approx. 25G).

Main Results:

  • Formulations lacking polysorbate exhibited significant increases in submicron and visible particles.
  • Formulations containing polysorbate showed minimal particle changes after shipping.
  • Repeated drop tests (25G) induced visible particles but not significant subvisible particle increases, suggesting vibration is also a factor.
  • Shock events were found to be repeatable and linked to sorting facility operations.

Conclusions:

  • Polysorbate is essential for maintaining the physical stability of liquid mAb formulations during shipping.
  • Shipping-induced shock and vibration pose risks to biopharmaceutical product quality.
  • Further research is needed to fully elucidate the interplay between mechanical stresses and mAb physical stability.