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Related Concept Videos

Optimizing Chromatographic Separations01:15

Optimizing Chromatographic Separations

Optimizing chromatographic separations is crucial for obtaining clean separations in a minimum amount of time. Optimization is required for several factors, including kinetic effects related to band broadening, plate height, capacity factor, and separation factor.
Band broadening refers to spreading solute bands as they travel through the column. This broadening can impact resolution. Plate height (H) represents the length required for one theoretical plate. A lower plate height corresponds to...
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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...
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High-Performance Liquid Chromatography: Elution Process

In High-Performance Liquid Chromatography (HPLC), the elution process is critical to the separation of analytes and the quality of chromatographic results. Elution describes how compounds move through the column and separate based on their interactions with the mobile and stationary phases. This process determines the resolution, peak shape, and retention times in the chromatogram, which are essential for identifying and quantifying components in complex mixtures. Understanding the elution...
Precipitation Processes01:12

Precipitation Processes

The experimental conditions in a gravimetric analysis should be optimized to maximize the particle size and purity of the obtained precipitate. Ideally, the concentration of the precipitating reagent should be low with effective stirring to maintain low relative supersaturation for the growth of large crystals. In homogeneous precipitation, the precipitant is slowly generated by a chemical reaction in the solution to avoid local reagent excesses. For example, urea decomposes gradually to...
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...
Extraction: Partition and Distribution Coefficients01:14

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The distribution law or Nernst's distribution law is the law that governs the distribution of a solute between two immiscible solvents. This law, also known as the partition law, states that if a solute is added to the mixture of two immiscible solvents at a constant temperature, the solute is distributed between the two solvents in such a way that the ratio of solute concentrations in the solvents remains constant at equilibrium.
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An Economical and Versatile High-Throughput Protein Purification System Using a Multi-Column Plate Adapter
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Published on: May 21, 2021

Using partition designs to enhance purification process understanding.

John Pieracci1, Leonard Perry, Lynn Conley

  • 1Biogen Idec, San Diego, California 92122, USA. john.pieracci@biogenidec.com

Biotechnology and Bioengineering
|July 16, 2010
PubMed
Summary
This summary is machine-generated.

Partition designs enable simultaneous modeling of multiple purification steps, revealing crucial cross-step interactions for robust monoclonal antibody process development.

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Area of Science:

  • Biopharmaceutical Manufacturing
  • Process Analytical Technology (PAT)
  • Chemical Engineering

Background:

  • Robust process characterization is essential for biopharmaceutical manufacturing.
  • Traditional experimental designs analyze process steps in isolation, limiting interaction insights.
  • Monoclonal antibody purification involves complex, sequential steps requiring advanced modeling.

Purpose of the Study:

  • To apply partition designs for simultaneous modeling of sequential purification steps.
  • To compare partition designs with traditional methods for process characterization.
  • To identify significant input parameters and inter-step interactions in monoclonal antibody purification.

Main Methods:

  • Utilized partition designs to model three sequential purification steps.
  • Employed traditional experimental designs for comparative analysis.
  • Assessed impact of input parameters on product quality output.

Main Results:

  • Both partition and traditional designs identified significant input parameters within individual steps.
  • Partition designs uniquely revealed significant interactions between parameters across sequential steps.
  • This highlights limitations of traditional, single-step analysis.

Conclusions:

  • Partition designs offer a superior approach for characterizing multi-step purification processes.
  • Simultaneous modeling via partition designs uncovers critical cross-step interactions missed by traditional methods.
  • This facilitates more robust and efficient development of biopharmaceutical purification processes.