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Questions and Answers
Which method of downstream processing is based on the principle of chromatography?
Which method of downstream processing is based on the principle of chromatography?
- Ion exchange
- Sterilization
- Immuno-affinity
- Adsorption (correct)
In downstream processing, what does the ion exchange method bind proteins based on?
In downstream processing, what does the ion exchange method bind proteins based on?
- Protein structure
- Protein size
- Protein charge (correct)
- Protein hydrophobicity
Which method uses antigenic regions to bind unwanted components?
Which method uses antigenic regions to bind unwanted components?
- Immuno-affinity (correct)
- Adsorption
- Ion exchange
- Sterilization
What does the sterilization process primarily remove or kill?
What does the sterilization process primarily remove or kill?
In which situation would sterilization be essential for a medical product?
In which situation would sterilization be essential for a medical product?
Which downstream processing method is NOT specifically related to purifying proteins?
Which downstream processing method is NOT specifically related to purifying proteins?
What is the purpose of downstream processing in biotechnology?
What is the purpose of downstream processing in biotechnology?
Which factor does NOT affect the sedimentation speed during downstream processing?
Which factor does NOT affect the sedimentation speed during downstream processing?
How does precipitation contribute to downstream processing?
How does precipitation contribute to downstream processing?
What is required for centrifugation during downstream processing to effectively separate products?
What is required for centrifugation during downstream processing to effectively separate products?
Why is it important for denser particles to move to the outside first during centrifugation?
Why is it important for denser particles to move to the outside first during centrifugation?
Which method of downstream processing is commonly used in the production of recombinant DNA polymerases?
Which method of downstream processing is commonly used in the production of recombinant DNA polymerases?
What is the primary purpose of sterility testing in downstream processing?
What is the primary purpose of sterility testing in downstream processing?
Why is sterilisation important in pharmaceutical production?
Why is sterilisation important in pharmaceutical production?
Which method is commonly used to ensure sterility assurance during downstream processing?
Which method is commonly used to ensure sterility assurance during downstream processing?
How do contaminants impact the success of sterilisation processes in pharmaceutical production?
How do contaminants impact the success of sterilisation processes in pharmaceutical production?
In what way does membrane filtration contribute to downstream processing?
In what way does membrane filtration contribute to downstream processing?
What is the key benefit of reducing risk of side effects while maintaining yield in pharmaceutical purification processes?
What is the key benefit of reducing risk of side effects while maintaining yield in pharmaceutical purification processes?
What is the purpose of sterility testing?
What is the purpose of sterility testing?
What does the purple to yellow color change in steam indicate?
What does the purple to yellow color change in steam indicate?
Why does achieving true sterility take a long time?
Why does achieving true sterility take a long time?
What is the purpose of membrane filtration in sterilization processes?
What is the purpose of membrane filtration in sterilization processes?
How does the nature of contaminants impact the success of sterilization?
How does the nature of contaminants impact the success of sterilization?
What is the microbial safety index aiming for in sterilization processes?
What is the microbial safety index aiming for in sterilization processes?
What is the major use of MWCO filters in sterilization?
What is the major use of MWCO filters in sterilization?
Which type of radiation requires heavy shielding due to its damaging effects on materials?
Which type of radiation requires heavy shielding due to its damaging effects on materials?
What is the mechanism of action assumed for ethylene oxide gas in sterilization?
What is the mechanism of action assumed for ethylene oxide gas in sterilization?
Why is ethylene oxide gas sterilization generally reserved for temperature-sensitive items?
Why is ethylene oxide gas sterilization generally reserved for temperature-sensitive items?
How are membrane filters different from depth filters in sterilization?
How are membrane filters different from depth filters in sterilization?
What is a key consideration when assessing the efficacy of filtration in sterilization?
What is a key consideration when assessing the efficacy of filtration in sterilization?
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Study Notes
Purification and Sterilization in MPharm Programme
- Downstream processing involves purification and sterilization of products to remove unwanted components and contaminants
- Purification involves separation of products from production mixtures using various methods such as sedimentation, precipitation, centrifugation, adsorption, and micro-filtration
Purification Methods
- Sedimentation: separates products based on cell size, density, and mixing speed
- Precipitation: lowers solute solubility and causes product to fall out of solution through chemical, temperature, or pH changes
- Centrifugation: applies centrifugal force to separate products based on different densities
- Adsorption: uses chromatography principle to capture proteins based on charge or antigenic regions
- Micro-filtration: uses filters with specified molecular weight cut-off (MWCO) to separate products
Why Purify?
- Increases yield and reduces risk of side effects
- Yield depends on the number of steps involved in the purification process
- Each step can result in loss of product, affecting the overall yield
Sterilization
- Sterilization involves the removal or destruction of all microorganisms, including bacteria, fungi, and viruses
- Sterility is achieved when there are no surviving microorganisms
- Sterilization methods include heat-based methods, gas-based methods, filtration, and radiation
Sterilization Methods
- Heat-based methods: moist heat (steam) and dry heat (oven) methods
- Gas-based methods: uses chemically reactive gases like ethylene oxide and formaldehyde
- Filtration: removes microorganisms using filters with varying pore sizes and compositions
- Radiation: uses ionizing and non-ionizing radiation to destroy microorganisms
Sterility Testing and Assurance
- Sterility testing involves incubating a sample in nutrient medium to check for microbial contamination
- Sterility assurance involves ensuring that the sterilization process is effective in reducing microbial populations
- Microbial safety index is used to ensure that the probability of a non-sterile unit is no more than 1 in 1 million (10-6)
Importance of Sterilization
- Sterilization is critical in pharmaceutical products, especially those that come into contact with mucosal surfaces or internal organs
- The nature of the contaminant affects the success of sterilization
- Sterilization methods must be selected based on the type of product and the level of microbial reduction required
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