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Related Experiment Videos

A decision-support model for evaluating changes in biopharmaceutical manufacturing processes.

S Chhatre1, R Francis, K O'Donovan

  • 1The Advanced Centre for Biochemical Engineering, University College London, Torrington Place, London WC1E 7JE, UK.

Bioprocess and Biosystems Engineering
|November 10, 2006
PubMed
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This study simulated bio-manufacturing process changes to optimize production. An improved rattlesnake anti-venom process using expanded bed affinity chromatography showed the most desirable results.

Area of Science:

  • Biopharmaceutical Manufacturing
  • Process Optimization
  • Bio-process Engineering

Background:

  • Current bio-manufacturing processes require optimization for efficiency and cost-effectiveness.
  • Altering feed parameters, downstream processing, and purification steps can impact production metrics.
  • Evaluating these modifications requires a comprehensive assessment framework.

Purpose of the Study:

  • To simulate and evaluate the impact of various bio-manufacturing process modifications.
  • To assess changes aimed at improving production levels, processing times, and costs.
  • To apply a multi-attribute decision-making (MADM) approach for option evaluation.

Main Methods:

  • Simulation of bio-manufacturing processes with modifications like increased feed titres, altered downstream stages (packed/expanded bed affinity), and ion exchange removal.

Related Experiment Videos

  • Evaluation of key performance indicators: manufactured product mass, cost of goods (COG), batch times, and development costs/timescales.
  • Application of multi-attribute-decision-making (MADM) techniques to generate a single assessment metric for each simulated option.

    • Main Results:

    • The simulation identified specific modifications that could significantly improve production efficiency.
    • An optimized process for rattlesnake anti-venom manufacturing was proposed.
    • The best-performing option involved an expanded bed affinity column with higher IgG titre and feed volume, omitting the ion exchange step.

    Conclusions:

    • The MADM simulation approach is a valuable tool for evaluating bio-manufacturing process improvements.
    • Process modifications, particularly in downstream purification, can lead to substantial gains in efficiency and cost reduction.
    • The proposed optimized process for rattlesnake anti-venom represents a potentially superior manufacturing alternative.