Related Experiment Video
Updated: Jun 23, 2026
09:28
Process Optimization using High Throughput Automated Micro-Bioreactors in Chinese Hamster Ovary Cell Cultivation
Published on: May 18, 2020
Quality-by-design for biotechnology-related pharmaceuticals
Carl-Fredrik Mandenius1, Klaus Graumann, Torsten W Schultz
1Linköping University, Sweden. cfm@ifm.liu.se
Biotechnology Journal
|May 7, 2009
Summary
This workshop report updates on Quality-by-Design (QbD) in pharmaceutical biotechnology. It covers industrial, academic, and regulatory insights, recommending future development for QbD applications.
Area of Science:
- Biochemical Engineering Science
- Pharmaceutical Biotechnology
Background:
- A workshop on Quality-by-Design (QbD) was held at the 7th European Symposium on Biochemical Engineering Science.
- The symposium focused on biotechnology applications within the pharmaceutical industry.
Purpose of the Study:
- To provide an update on the current status of Quality-by-Design (QbD) implementation.
- To discuss the industrial, academic, and regulatory perspectives of QbD in pharmaceutical biotechnology.
Main Methods:
- Summarizing key presentations from the workshop.
- Consolidating information on QbD from various stakeholders.
Main Results:
- The workshop provided a comprehensive overview of QbD in pharmaceutical biotechnology.
- Essential aspects of QbD were presented covering industrial, academic, and regulatory viewpoints.
Conclusions:
- QbD is a developing area in pharmaceutical biotechnology with ongoing research and application.
- Recommendations for future work and development in QbD were established.
More Related Videos
Related Concept Videos
01:22Biopharmaceutical 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...
01:29Clinically Relevant Drug Product Specifications: Methods of Establishment
Product specifications define the acceptable quality of a pharmaceutical product by ensuring identity, purity, potency, and strength. These specifications serve as benchmarks during development, manufacturing, and post-approval quality control. Clinically relevant specifications are particularly important because they directly relate to a drug's safety and efficacy in clinical use.Dissolution studies are critical biopharmaceutic tools that link in vitro behavior to in vivo performance. They...
01:28Drug Products: Biologics, Biosimilars and Interchangeables
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...
01:26Good Manufacturing Practices
Good Manufacturing Practices (GMP) constitute a foundational set of guidelines that ensure the production of safe, consistent, and high-quality products, particularly in industries such as pharmaceuticals, biotechnology, and food processing. These protocols encompass all aspects of production, from the sourcing of raw materials to the final distribution of the finished product.A core pillar of GMP is stringent hygiene and sanitation across all production environments. This includes routine...
01:27Upstream 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...
01:16Bioequivalence: Overview
Pharmaceutical equivalents, by definition, are drug products with the same active ingredient in the same quantities, encapsulated in identical dosage forms, and intended for the same administration routes. These pharmaceutical equivalents are deemed bioequivalent if the bioavailability of the active entity in the drug preparations is similar. Moreover, pharmaceutical equivalents demonstrating bioequivalence are also regarded as therapeutically equivalent. This means that when used as directed,...