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PROCESS ECONOMICS AND OPTIMIZATION

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For a typical downstream processing train, the initial investment in equipment and consumable filtration membrane resins are very expensive.

to a moderate scale production, grams to a few kgs yearly the procedure will consume a lot of liquid which approximately 2-3 dollars per liter and that cost can go up to 7-8 dollars if its formulation is put into processing buffers.

Adding up to the cost is the capital of equipment’s and consumables, staffing costs and ongoing facility operating costs e.g. utilities, transportation and maintenance.

Given the nature of production expenses, it is advisable that the yield of purified downstream processing drug must be maximized to maintain economic viability of a drug candidate as it progresses through approval processes. Some of the common sources of product yield losses are:

  • When eluted fractions bind downstream processing steps when the liquid holds up within the pipe work and on the retentive of in-concentration in the TFF cartridges.

The following are the steps that can be taken to avert defer loses:

  • Heat exchangers on TFF systems mostly on retentive recirculation loops.
  • Tulip-shaped TFF retentive tanks
  • Shortened holding times to reduce product degradation time.

Other means to optimize process economics are:

  • Process compression. This helps in reducing the number of processing steps as each contributes to recovery loses.
  • Downstream processing times by increasing productivity to conserve product stability and reduce labor.
  • Concentrate on reducing working volumes which helps to save on tank volume and floor space, as well as production time and labor.
  • Automation would be efficient as it would help reduce potential for errors and any other risks.
  • Due to hand-over, continuity is necessary so as to prevent any errors that may occur during hand-over. In this case it is advised to time steps to allow completion within

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