Theoretical Industrial Bioscience Process

There are many detailed considerations involved in the manufacture / recovery of a product of bioscience. We will examine a few general steps of a highly simplified procedure. This case study is intended to give the student a sense of how the "flow" of events occurs in a industrial bioscience production. The first requirement is to acquire an appropriate starting material for the process.

Regardless of the source material, it will enter the facility and must undergo appropriate testing (through the analytical and quality control functions) to ensure it meets or exceeds production requirements. In the case of our example process, we will consider the product to be the result of an in-house bacterial fermentation / cell culture. The fermentation will require continual monitoring of indicators such as nutrient levels, oxygen / carbon dioxide, and the electrolyte balance, etc. The inputs will include appropriate nutrients, oxygen and other necessary materials. The output of the fermentation will be a semi-continuous waste-stream which generates a potentially valuable metabolite along with the other by-products of metabolism.

With an adequate supply of the source material / crude product we can begin the actual processing to recover our value-added product. For this we will employ filtration (to clarify, remove cellular debris and contaminants and concentration using ultrafiltration membranes (to reduce volume). This will provide us with a clean (sanitary) crude product with a manageable working volume.

The product is now a more manageable 500 L and the relative purity has increased from an initial 2% to 15% RP. Obviously a substantial amount of LMW (low molecular weight) contaminants have been removed. At this stage microfiltration (filtration to remove extremely small contaminants such as bacteria) will be conducted. This will not only improve purity by removing low-solubility once again, but will also increase processing period by removing most (if not all) microorganisms.

The product is now ready for liquid chromatography; the purification tool which will be used for the bulk of the purification. In liquid chromatography one component is immobilized on an inert matrix (such as plastic beads / resin) while other components are washed away through several "wash" cycles. Extreme care must be taken to remove only the contaminants (and not the product) during this washing cycles so involvement of the analytical personnel should be expected.

Product is now 65% pure. Analytical and quality control actions are performed to ensure product quality standards have been attained for this stage of the procedure. Selective Fractionation / Precipitation will be used to reach the final quality targets.

The product is now ready for the analytical and quality control personnel to determine if it has reached adequate quality standards / purification for "certification" as final product following the quality system. This will include analyses, a review of production records and analytical data to ensure all measureable control points have been attained for each stage of production.

The initial crude product with a relative purity of 25 has been processed to a valuable marketable commoditiy of 95% relative purity. Throughout the procedure the production, analytical and quality functions have interacted to produce a predictable product with a high degree of accountability for every stage of the process. Let's go on to examine the various elements (production, analysis, quality systems) more closely.