CBE653 Downstream Processing UITM Assignment Sample Malaysia

The CBE653 Downstream Processing course is designed to provide students with the knowledge and skills necessary to perform various downstream processing tasks related to the purification of biochemicals and pharmaceuticals. The course covers topics such as chromatography, filtration, and centrifugation, and includes laboratory sessions in which students can gain hands-on experience with some of the techniques covered in the lectures.

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In this section, we will discuss some assignment activities. These are:

Assignment Activity 1: Explain the stages of downstream processes and its application.

Downstream processing refers to the purification and isolation of the desired biomolecules from a complex mixture, such as a fermentation broth or cell lysate, after upstream processing. Downstream processing typically consists of several stages, which are explained below:

1. Harvesting: This stage involves separating the cells or biomass from the culture broth by using techniques such as centrifugation, filtration, or sedimentation.
2. Cell Disruption: After harvesting, the cells are disrupted to release the intracellular biomolecules, such as proteins or nucleic acids. This is achieved by mechanical, chemical, or enzymatic methods.
3. Clarification: This stage involves removing insoluble impurities, such as cell debris, precipitates, or other contaminants, from the disrupted cell mixture. The clarified supernatant can be used for subsequent purification steps.
4. Purification: The clarified supernatant is subjected to various purification methods, such as chromatography, precipitation, or membrane filtration, to separate and purify the desired biomolecule from other impurities.
5. Concentration: The purified biomolecule is concentrated to increase its potency and reduce the volume for storage or further processing.
6. Formulation: The final stage involves formulating the concentrated biomolecule into a stable and effective product by adding excipients such as buffers, stabilizers, and preservatives.

The downstream processing has numerous applications in various industries, including biopharmaceuticals, food and beverage, and environmental biotechnology. For example, in the biopharmaceutical industry, downstream processing is used to produce monoclonal antibodies, hormones, enzymes, and vaccines. In the food and beverage industry, downstream processing is used to extract and purify proteins, enzymes, and other functional ingredients from natural sources such as milk, soy, and egg whites. In environmental biotechnology, downstream processing is used to remove pollutants, toxins, and other contaminants from wastewater, soil, and air.

Assignment Activity 2: Differentiate the stages of downstream processes according to the design and applications.

Downstream processing is the purification and recovery of a biotechnological product from a crude mixture obtained through upstream processing. The downstream process is typically divided into three stages, which are based on the design and applications:

1. Primary recovery: This stage involves the initial separation of the product from the biomass or fermentation broth. Primary recovery processes include centrifugation, filtration, and cell disruption techniques such as homogenization or sonication. The aim is to obtain a clarified and partially purified product, which can be further processed in the subsequent steps.
2. Secondary recovery: This stage involves the further purification of the product to remove any impurities, including host cell proteins, nucleic acids, and endotoxins. Secondary recovery processes include chromatography, precipitation, and crystallization. The aim is to obtain a highly purified product that meets the required quality specifications for the intended application.
3. Tertiary recovery: This stage involves the final polishing of the product to achieve the desired level of purity and activity. Tertiary recovery processes include additional chromatography steps, ultrafiltration, and diafiltration. The aim is to ensure that the final product meets the required regulatory and quality standards for pharmaceutical, food, or industrial applications.

Assignment Activity 3: Evaluate the integration of the downstream processes based on the design and applications.

To evaluate the integration of downstream processes based on design and applications, I would need more information about the specific downstream processes being referred to, as well as the design and applications involved. Downstream processes typically refer to the processing and purification of biopharmaceutical products, such as proteins, antibodies, and vaccines.

To evaluate the integration of downstream processes, one could consider factors such as efficiency, yield, purity, scalability, and cost-effectiveness. The design of downstream processes should be optimized to maximize product recovery and purity while minimizing the number of steps required. The integration of downstream processes with upstream processes, such as cell culture or fermentation, should be seamless to ensure a continuous and efficient production process.

Similarly, the application of downstream processes should be evaluated based on their ability to meet the desired product specifications and performance requirements. This could involve testing the product for purity, potency, stability, and safety. Additionally, downstream processes should be scalable to meet the demand for the product and cost-effective to ensure commercial viability.

Overall, the evaluation of downstream processes based on design and applications requires a detailed understanding of the specific processes involved and their intended use.

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