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

Drug Products: Biologics, Biosimilars and Interchangeables01:28

Drug Products: Biologics, Biosimilars and Interchangeables

345
Biologics, derived from living sources such as humans, animals, or microorganisms, represent a significant category of pharmaceuticals. These complex molecules, developed through advanced biotechnological methods or purified from natural sources, include essential medical treatments like insulin and growth hormones. The complexity of biologics arises from their large molecular structures and the intricate processes required for their production, making them distinct from conventional...
345
Upstream Processing01:27

Upstream Processing

2
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...
2
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

520
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,...
520
Biopharmaceutical Factors Influencing Drug Product Design: Overview01:22

Biopharmaceutical Factors Influencing Drug Product Design: Overview

408
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...
408
Microorganisms in Medicine and Therapeutics01:29

Microorganisms in Medicine and Therapeutics

1.3K
Microorganisms play a fundamental role in vaccine development, gene therapy, and therapeutic production. Their biological properties are harnessed to advance medicine and public health. Beyond immunization, microorganisms contribute to gut health, antibiotic synthesis, and genetic disease treatment.Live Attenuated and Inactivated VaccinesLive attenuated vaccines, such as the measles, mumps, and rubella (MMR) vaccine, utilize weakened forms of pathogens to closely resemble natural infections.
1.3K
Drug Biotransformation: Overview01:16

Drug Biotransformation: Overview

4.1K
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...
4.1K

You might also read

Related Articles

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

Sort by
Same author

BRD2 bromodomain-mediated regulation of cell state plasticity modulates therapy response in glioblastoma.

Neuro-oncology·2025
Same author

Impact of vein-to-vein time in patients with R/R LBCL treated with axicabtagene ciloleucel.

Blood advances·2025
Same author

Torsional disorder in tetraphenyl [3]-cumulenes: Insight into the excited state quenching.

Photochem·2024
Same author

Small to Large Polaron Behavior Induced by Controlled Interactions in Perovskite Quantum Dot Solids.

ACS nano·2023
Same author

Glioblastoma Mesenchymal Transition and Invasion are Dependent on a NF-κB/BRD2 Chromatin Complex.

bioRxiv : the preprint server for biology·2023
Same author

A turn in species conservation for hairpin banksias: demonstration of oversplitting leads to better management of diversity.

American journal of botany·2022

Related Experiment Video

Updated: Mar 19, 2026

Purification and Analytics of a Monoclonal Antibody from Chinese Hamster Ovary Cells Using an Automated Microbioreactor System
10:50

Purification and Analytics of a Monoclonal Antibody from Chinese Hamster Ovary Cells Using an Automated Microbioreactor System

Published on: May 1, 2019

15.4K

Risk Management in Biologics Technology Transfer.

Robert Toso, Jonathan Tsang, Jasmina Xie

    PDA Journal of Pharmaceutical Science and Technology
    |June 22, 2016
    PubMed
    Summary

    Managing risks during biological product technology transfer is crucial for commercialization. Iterative risk analysis and tailored strategies, supported by cross-functional teams and documentation, ensure successful technology transfer.

    Keywords:
    Biopharmaceutical processesRisk managementTechnology transfer

    More Related Videos

    Laboratory Scale Production and Purification of a Therapeutic Antibody
    09:54

    Laboratory Scale Production and Purification of a Therapeutic Antibody

    Published on: January 24, 2017

    18.5K
    Author Spotlight: Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies
    09:30

    Author Spotlight: Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies

    Published on: March 17, 2023

    4.6K

    Related Experiment Videos

    Last Updated: Mar 19, 2026

    Purification and Analytics of a Monoclonal Antibody from Chinese Hamster Ovary Cells Using an Automated Microbioreactor System
    10:50

    Purification and Analytics of a Monoclonal Antibody from Chinese Hamster Ovary Cells Using an Automated Microbioreactor System

    Published on: May 1, 2019

    15.4K
    Laboratory Scale Production and Purification of a Therapeutic Antibody
    09:54

    Laboratory Scale Production and Purification of a Therapeutic Antibody

    Published on: January 24, 2017

    18.5K
    Author Spotlight: Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies
    09:30

    Author Spotlight: Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies

    Published on: March 17, 2023

    4.6K

    Area of Science:

    • Biotechnology
    • Pharmaceutical Sciences
    • Process Engineering

    Background:

    • Technology transfer of biological products is critical for commercialization.
    • Managing risks associated with process changes is essential for successful transfer.
    • Unforeseen circumstances can introduce significant risks during technology transfer.

    Purpose of the Study:

    • To outline a strategy for managing risks in biological product technology transfer.
    • To demonstrate the utility of iterative risk analysis and mitigation tools.
    • To highlight the importance of tailored risk assessment and team collaboration.

    Main Methods:

    • Utilizing an iterative risk analysis and mitigation approach.
    • Employing a technology transfer stage gate model as a risk management framework.
    • Tailoring risk assessment strategies based on the nature of process changes.
    • Leveraging cross-functional teams and centralized documentation.

    Main Results:

    • Iterative risk analysis effectively evaluates and reduces risks.
    • The stage gate model aids in managing risks from both designed and unplanned changes.
    • Tailored risk assessment strategies improve management efficiency.
    • Cross-functional teams and centralized documentation enhance overall risk management.

    Conclusions:

    • Effective risk management is paramount for successful biological product technology transfer.
    • A combination of iterative analysis, tailored strategies, and collaborative teamwork optimizes the transfer process.
    • Implementing structured risk management frameworks leads to efficient and successful commercialization.