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Related Concept Videos

Production of Pharmaceuticals01:30

Production of Pharmaceuticals

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Industrial insulin production uses genetically engineered E. coli expressing a proinsulin gene controlled by a tryptophan promoter and containing a methionine linker for later cleavage. The cells also carry ampicillin resistance for selective growth. Seed cultures are stored at −80 °C and production begins by thawing a small amount to inoculate starter cultures, which are progressively scaled to a 50,000-L bioreactor. In the bioreactor, E. coli grow in nutrient-rich media under...
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Upstream Processing01:27

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

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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...
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Bioreactor Controls-III01:22

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Strain improvement is a foundational strategy in industrial microbiology aimed at maximizing microbial productivity, particularly because natural isolates typically yield commercially valuable products in very low concentrations. Although optimizing the culture medium and environmental conditions can improve yields, these adjustments are inherently limited by the organism’s genetic potential. As a result, the focus shifts toward genetic modifications to enhance biosynthetic capacity. The...
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Biopharmaceutics and Pharmacokinetics: Overview01:28

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Understanding drugs, drug products, and their performance in pharmaceutical science is pivotal. Drugs, whether simple molecules or complex compounds, are designed to interact with the body's biological systems to diagnose, treat, or prevent diseases. Drug products include various delivery systems such as tablets, capsules, injections, and inhalers. The performance of these drug products is gauged by their ability to deliver the active ingredient to the desired site of action at the...
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Vaccine Production01:23

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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...
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The Future of Pharmaceutical Manufacturing Sciences.

Jukka Rantanen1, Johannes Khinast2

  • 1Department of Pharmacy, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.

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|August 18, 2015
PubMed
Summary
This summary is machine-generated.

Manufacturing advanced drug delivery systems (DDSs) requires innovative technologies and scientific approaches. This review explores manufacturing sciences, from risk management and modeling to future solutions like continuous processing for better healthcare.

Keywords:
in silico modelingmaterials sciencemathematical modelprocess analytical technology (PAT)quality by design (QBD)

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Area of Science:

  • Pharmaceutical Manufacturing
  • Drug Delivery Systems
  • Process Engineering

Background:

  • The pharmaceutical industry faces challenges in manufacturing highly engineered drug products.
  • Current technologies struggle with the commercial-scale production of complex drug delivery systems (DDSs).

Purpose of the Study:

  • To review key elements of manufacturing sciences for advanced DDS production.
  • To discuss current and future technologies, including computational and materials science approaches.

Main Methods:

  • Review of risk management strategies and Design of Experiments (DoE).
  • Detailed description of mechanistic process modeling techniques.
  • Exploration of materials science tools and engineering principles for process control.

Main Results:

  • Integration of computational and experimental methods enhances DDS manufacturing.
  • Materials science enables molecular-based processing for future DDS.
  • Continuous processing, hot-melt extrusion, and printing technologies represent future manufacturing solutions.

Conclusions:

  • Advanced manufacturing sciences are crucial for producing next-generation DDS.
  • Implementing innovative technologies faces challenges within current healthcare systems.