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

Upstream Processing01:27

Upstream Processing

Upstream processing represents a critical phase in biomanufacturing, wherein biological systems such as microorganisms, mammalian cells, or insect cells are cultivated to produce therapeutic proteins, vaccines, enzymes, or other biologically derived products. This phase encompasses all steps from the selection and genetic manipulation of the production organism to the cultivation of cells in bioreactors under tightly controlled environmental conditions.Host Selection and Genetic OptimizationThe...
Drug Discovery: Overview01:26

Drug Discovery: Overview

Drug discovery is a multifaceted process involving extensive screening, testing, and optimization of lead compounds to identify potential new drugs for therapeutic use. It combines several approaches, including screening large numbers of natural products, chemical modification of known active molecules, identification of new drug targets, and rational design based on biological mechanisms and drug-receptor structure. These approaches are carried out in both academic research laboratories and...
Downstream Processing01:29

Downstream Processing

Downstream processing begins once fermentation is complete and involves a series of steps to recover and purify products such as acids, vitamins, antibiotics, or proteins.Cell HarvestingFor example, for intracellular protein-based products, the first step is harvesting the cells. This is typically achieved using centrifugation or filtration to separate the cells from the liquid phase.Cell Disruption for Intracellular ProductsIf the target product is intracellular, the harvested cells must be...
Preclinical Development: Overview01:28

Preclinical Development: Overview

Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
Drug Biotransformation: Overview01:16

Drug Biotransformation: Overview

Pharmaceutical substances known as xenobiotics are predominantly lipophilic and nonionized. This enables them to permeate lipid bilayers, such as cell membranes, and interact with intracellular target receptors. Lipophilic drugs have an advantage in crossing biological barriers and reaching their intended sites of action. However, lipophilic drugs often have a restricted capacity for renal expulsion or elimination from the body. When these drugs enter the kidneys and undergo glomerular...
Biopharmaceutical Factors Influencing Drug Product Design: Overview01:22

Biopharmaceutical Factors Influencing Drug Product Design: Overview

Rational drug product design integrates knowledge of the drug’s physicochemical properties, formulation components, manufacturing techniques, and intended route of administration. Each factor influences the drug’s performance, including how it is released, absorbed, and eliminated in the body.The physicochemical properties of a drug—such as solubility, stability, and particle size—affect its compatibility with excipients and the choice of dosage form. Excipients, though pharmacologically...

You might also read

Related Articles

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

Sort by
Same author

Targeting Warburg effect in Chinese hamster ovary cell culture with pyruvate dehydrogenase kinase inhibitors.

Biotechnology progress·2026
Same author

Osmolyte-Based Formulations for Enhanced Thermal Stability of mRNA Drug Substance: A Systematic Screening and Optimization Study.

Pharmaceutical research·2026
Same author

Structural Elucidation of Fc- and Fab-Associated <i>N</i>-Glycans in Cetuximab Using Protein A-Assisted Domain-Resolved Glycan Profiling Using Mass Spectrometry.

Journal of the American Society for Mass Spectrometry·2026
Same author

HF-SNVTA-FusionNet: high-frequency multi-domain EEG feature fusion from the substantia nigra and ventral tegmental area for Parkinson's disease classification.

Cognitive neurodynamics·2026
Same author

Bioinformatic pipeline to identify potential therapeutic targets with subsequent isolation and characterization of novel human anti- DDR1 antibodies.

Scientific reports·2026
Same author

Rapid Identification of Counterfeit Biopharmaceuticals using Portable Fourier Transform Infrared Spectroscopy.

AAPS PharmSciTech·2026

Related Experiment Video

Updated: Jun 5, 2026

Process Optimization using High Throughput Automated Micro-Bioreactors in Chinese Hamster Ovary Cell Cultivation
09:28

Process Optimization using High Throughput Automated Micro-Bioreactors in Chinese Hamster Ovary Cell Cultivation

Published on: May 18, 2020

High-throughput process development for biopharmaceutical drug substances.

Rahul Bhambure1, Kaushal Kumar, Anurag S Rathore

  • 1Department of Chemical Engineering, Indian Institute of Technology Delhi, Hauz Khas, New Delhi 110016, India.

Trends in Biotechnology
|January 25, 2011
PubMed
Summary
This summary is machine-generated.

Quality by Design (QbD) enhances biotechnology therapeutic product development. High-throughput tools are essential for QbD implementation, enabling consistent quality attribute delivery within budget and time constraints.

More Related Videos

A High-throughput Automated Platform for the Development of Manufacturing Cell Lines for Protein Therapeutics
07:48

A High-throughput Automated Platform for the Development of Manufacturing Cell Lines for Protein Therapeutics

Published on: September 22, 2011

Generic Protocol for Optimization of Heterologous Protein Production Using Automated Microbioreactor Technology
06:24

Generic Protocol for Optimization of Heterologous Protein Production Using Automated Microbioreactor Technology

Published on: December 15, 2017

Related Experiment Videos

Last Updated: Jun 5, 2026

Process Optimization using High Throughput Automated Micro-Bioreactors in Chinese Hamster Ovary Cell Cultivation
09:28

Process Optimization using High Throughput Automated Micro-Bioreactors in Chinese Hamster Ovary Cell Cultivation

Published on: May 18, 2020

A High-throughput Automated Platform for the Development of Manufacturing Cell Lines for Protein Therapeutics
07:48

A High-throughput Automated Platform for the Development of Manufacturing Cell Lines for Protein Therapeutics

Published on: September 22, 2011

Generic Protocol for Optimization of Heterologous Protein Production Using Automated Microbioreactor Technology
06:24

Generic Protocol for Optimization of Heterologous Protein Production Using Automated Microbioreactor Technology

Published on: December 15, 2017

Area of Science:

  • Biotechnology
  • Pharmaceutical Sciences
  • Process Engineering

Background:

  • Quality by Design (QbD) is an increasingly adopted framework for developing and commercializing biotechnology therapeutics.
  • Current industry pressures necessitate cost-effective manufacturing and efficient development timelines.
  • Achieving robust QbD requires comprehensive process understanding and extensive experimentation.

Purpose of the Study:

  • To review the role of high-throughput tools in enabling Quality by Design for biotechnology drug substance process development.
  • To highlight the importance of these tools in resource-constrained environments.
  • To provide insights for academic and industry professionals in drug substance process development.

Main Methods:

  • Literature review of Quality by Design principles and applications in biotechnology.
  • Analysis of the integration of high-throughput tools within the QbD framework.
  • Discussion of experimental strategies for establishing process design space.

Main Results:

  • High-throughput tools are critical for accelerating the extensive experimentation needed for QbD.
  • These tools facilitate the establishment of a robust design space for biopharmaceutical processes.
  • Implementing QbD with high-throughput tools helps meet cost and time pressures in manufacturing.

Conclusions:

  • High-throughput tools are indispensable for the successful and efficient implementation of Quality by Design in biotechnology.
  • Adoption of QbD, supported by high-throughput methodologies, leads to consistent product quality and manufacturing efficiency.
  • This approach is vital for academic and industrial researchers focused on biopharmaceutical process development.