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

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

124
Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
124
Actuarial Approach01:20

Actuarial Approach

69
The actuarial approach, a statistical method originally developed for life insurance risk assessment, is widely used to calculate survival rates in clinical and population studies. This method accounts for participants lost to follow-up or those who die from causes unrelated to the study, ensuring a more accurate representation of survival probabilities.
Consider the example of a high-risk surgical procedure with significant early-stage mortality. A two-year clinical study is conducted,...
69

You might also read

Related Articles

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

Sort by
Same author

CellVision: A deep learning based image analysis platform to accelerate immuno-plaque assay data processing for dengue vaccine development.

SLAS discovery : advancing life sciences R & D·2026
Same author

High concentration subcutaneous biological drug products: challenges and advancements.

Advanced drug delivery reviews·2026
Same author

A Dehydration-Diffusion Competition Framework Predicts Interfacial Film Risk in High-Concentration Biologics Fill-Finish.

Molecular pharmaceutics·2025
Same author

Predictive stability in biopharmaceuticals and vaccines: Perspectives and recommendations towards accelerating patient access.

Journal of pharmaceutical sciences·2025
Same author

Bayesian hierarchical model predicts biopharmaceutical stability indicators and shelf life with application to multivalent human papillomavirus vaccine.

Scientific reports·2025
Same author

Enzymatic Desialylation Enables Reliable Charge Variant Characterization of Highly Glycosylated and Sialylated Fc Fusion Proteins.

ACS pharmacology & translational science·2025

Related Experiment Video

Updated: Jun 17, 2025

Quantification of the Immunosuppressant Tacrolimus on Dried Blood Spots Using LC-MS/MS
08:38

Quantification of the Immunosuppressant Tacrolimus on Dried Blood Spots Using LC-MS/MS

Published on: November 8, 2015

16.9K

Predicting the Long-Term Stability of Biologics with Short-Term Data.

Michael Dillon1, Jun Xu1, Geetha Thiagarajan2

  • 1Sterile Product Development, Pharmaceutical Sciences & Clinical Supply, Merck & Co., Inc., 126 East Lincoln Avenue, Rahway, New Jersey 07065, United States.

Molecular Pharmaceutics
|August 9, 2024
PubMed
Summary

A new kinetic model accurately predicts long-term biologic drug stability using just six months of data. This approach accelerates the availability of life-saving therapeutics by reducing lengthy real-time stability testing requirements.

Keywords:
antibodiesbiopharmaceuticalsbiotechnologymodelingstability

More Related Videos

Measuring Protein Stability in Living Zebrafish Embryos Using Fluorescence Decay After Photoconversion FDAP
09:45

Measuring Protein Stability in Living Zebrafish Embryos Using Fluorescence Decay After Photoconversion FDAP

Published on: January 28, 2015

11.2K
Dried Blood Spots - Preparing and Processing for Use in Immunoassays and in Molecular Techniques
11:28

Dried Blood Spots - Preparing and Processing for Use in Immunoassays and in Molecular Techniques

Published on: March 13, 2015

40.1K

Related Experiment Videos

Last Updated: Jun 17, 2025

Quantification of the Immunosuppressant Tacrolimus on Dried Blood Spots Using LC-MS/MS
08:38

Quantification of the Immunosuppressant Tacrolimus on Dried Blood Spots Using LC-MS/MS

Published on: November 8, 2015

16.9K
Measuring Protein Stability in Living Zebrafish Embryos Using Fluorescence Decay After Photoconversion FDAP
09:45

Measuring Protein Stability in Living Zebrafish Embryos Using Fluorescence Decay After Photoconversion FDAP

Published on: January 28, 2015

11.2K
Dried Blood Spots - Preparing and Processing for Use in Immunoassays and in Molecular Techniques
11:28

Dried Blood Spots - Preparing and Processing for Use in Immunoassays and in Molecular Techniques

Published on: March 13, 2015

40.1K

Area of Science:

  • Biopharmaceutical science
  • Chemical kinetics
  • Computational modeling

Background:

  • Ensuring long-term biologic drug stability is vital for therapeutic safety and efficacy.
  • Current stability testing requires three years of real-time data, creating a significant bottleneck.
  • Accelerating this process can expedite patient access to critical medicines.

Purpose of the Study:

  • To develop and validate a predictive model for long-term biotherapeutic stability using short-term data.
  • To reduce the time and resources required for stability assessments.
  • To enhance the speed of bringing biologics to market.

Main Methods:

  • Developed a parallel-pathway kinetic model integrated with Monte Carlo simulations.
  • Utilized short-term stability data (3-6 months) from various temperatures (intended, accelerated, stressed).
  • Validated the model across 18 diverse biotherapeutic products, including monoclonal antibodies and fusion proteins.

Main Results:

  • Accurately predicted long-term stability trends (2+ years) for multiple critical quality attributes using only 6 months of data.
  • Demonstrated superior predictive performance compared to industry-standard linear regression methods.
  • Achieved robust and repeatable predictions across a wide range of biopharmaceutical formulations.

Conclusions:

  • Kinetic modeling combined with Monte Carlo simulations offers a reliable method for predicting long-term biologic stability from short-term data.
  • This approach significantly reduces the need for extensive real-time stability studies.
  • The validated model can accelerate drug development and improve the efficiency of biopharmaceutical manufacturing.