18 Questions
What is a primary concern related to protein aggregates in protein drugs?
Enhanced immunogenicity of the product
What is the main reason for manipulating external factors in protein formulation?
To address physical instability of therapeutic proteins
What is the term for assemblies of native or partially denatured protein molecules?
Aggregates
What is the result of exceeding the solubility limit of a protein?
Precipitation of the protein
What are the two major types of factors that affect protein aggregation?
Internal and external factors
What is the goal of the second step in manipulating external factors in protein formulation?
To maximize intermolecular repulsion between protein molecules
What type of instability occurs when the chemical composition of a protein remains unaltered, but its physical state changes?
Physical instability
Which of the following is a factor that influences the chemical instability of a protein molecule?
All of the above
What is the process by which a protein's unique three-dimensional structure is disrupted, often due to changes in temperature, pH, or other chemical activities?
Denaturation
What type of protein instability involves the formation of new chemical entities, resulting in changes to the protein's chemical composition?
Chemical instability
Which of the following is a physical instability that involves the protein coming out of solution?
Precipitation
What is the process by which proteins interact with each other, resulting in the formation of larger protein aggregates?
Aggregation
What is the primary motivation for using PEGylation as a synthetic method for protein modification?
To minimize protein aggregation to an acceptable level
What is the recommended storage temperature range for therapeutic proteins to prevent degradation?
2-8 °C
What is a potential consequence of an immune reaction to a therapeutic protein?
Severe hypotension and anaphylaxis
Why may process-related factors be insufficient to minimize protein aggregation?
Because the protein has a high tendency to aggregate
What is a characteristic of therapeutic proteins that can lead to immunogenicity?
Their exogenous nature
What is a potential chemical instability of therapeutic proteins?
Degradation at room temperature
Understand the concepts of protein precipitation, aggregation, and their effects on therapeutic protein efficacy and immunogenicity. Learn about the physical instability of protein drugs and how it relates to solubility limits and denaturation.
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