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Related Concept Videos

Vaccine Production01:23

Vaccine Production

Vaccine production involves a sequence of upstream and downstream processes to generate a safe and effective immunological product. It begins with cultivating microorganisms, such as viruses or bacteria, to obtain antigenic material. For viral vaccines, mammalian host cells are grown in bioreactors and subsequently infected with the target virus. The virus replicates within the host cells, which are lysed to release viral particles. This lysate is then clarified through filtration or...
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

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, controlled...
Microorganisms in Medicine and Therapeutics01:29

Microorganisms in Medicine and Therapeutics

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.
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...
In Vitro Drug Release Testing: Overview, Development and Validation01:10

In Vitro Drug Release Testing: Overview, Development and Validation

In vitro dissolution and drug release tests assess how quickly and how much of a drug is released from its dosage form into an aqueous medium under standardized laboratory conditions. These tests are essential tools in pharmaceutical development and quality assurance, offering insight into the drug's performance before clinical use.During formulation development, dissolution testing identifies incomplete or inconsistent drug release issues. It also supports decisions on selecting the optimal...
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Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence

Pharmaceutical products contain more than just the active drug; they also contain various excipients such as binders, solubilizers, stabilizers, preservatives, and other elements. In some cases, impurities or contaminants might be present. Traditionally, quality control in pharmaceuticals has primarily focused on the analysis of the active drug, often overlooking the impact of these additional components. The recent issue with heparin contamination by over-sulfated chondroitin sulfate, a...

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Related Experiment Video

Updated: Jun 25, 2026

Expression and Purification of Virus-like Particles for Vaccination
06:17

Expression and Purification of Virus-like Particles for Vaccination

Published on: June 2, 2016

Quality-control issues and approaches in vaccine development.

Bernard Metz1, Germie van den Dobbelsteen, Cécile van Els

  • 1Research and Development Unit, Netherlands Vaccine Institute, Bilthoven, The Netherlands. bernard.metz@nvi-vaccin.nl

Expert Review of Vaccines
|February 7, 2009
PubMed
Summary

Developing effective vaccines requires rigorous quality control throughout the entire process, from discovery to post-licensure. High-quality assays are crucial for reducing clinical trial failures and ensuring vaccine safety and efficacy.

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Area of Science:

  • Immunology and Vaccinology
  • Biopharmaceutical Quality Control
  • Regulatory Science

Background:

  • Vaccine development is a complex, multi-stage process involving diverse expertise.
  • Ensuring vaccine quality is paramount for successful clinical trials and regulatory approval.
  • Assay development plays a critical role in mitigating risks throughout the vaccine lifecycle.

Purpose of the Study:

  • To review quality-control issues and strategies in vaccine development.
  • To examine quality control from discovery through post-licensure phases.
  • To highlight the importance of high-quality assays in vaccine success.

Main Methods:

  • Literature review of quality control in vaccine development.
  • Analysis of quality control from various expert perspectives.
  • Examination of assay development and its impact on clinical trials.

Main Results:

  • Quality control is essential at every stage: discovery, process development, assay development, clinical trials, and post-licensure.
  • High-quality assays are fundamental for reducing the risk of clinical trial failure.
  • A multidisciplinary approach is necessary for robust vaccine quality assurance.

Conclusions:

  • Effective vaccine development hinges on comprehensive quality control measures.
  • The strategic implementation of validated assays is critical for regulatory success.
  • Continuous quality assessment ensures the safety and efficacy of vaccines in the market.