Podcast
Questions and Answers
Which organization defines Critical Quality Attributes (CQAs) for protein therapeutics?
Which organization defines Critical Quality Attributes (CQAs) for protein therapeutics?
- Food and Drug Administration (FDA)
- International Council for Harmonization (ICH) (correct)
- World Health Organization (WHO)
- European Medicines Agency (EMA)
What is one of the critical quality attributes (CQAs) that must be measured for a therapeutic protein?
What is one of the critical quality attributes (CQAs) that must be measured for a therapeutic protein?
- Protein Concentration (correct)
- Storage Temperature
- Manufacturing Process
- Packaging Material
Why is aggregation a concern in biomanufacturing?
Why is aggregation a concern in biomanufacturing?
- Proteins clumping together can affect their function in the body
- Aggregation can lead to an immune response
- Aggregates can cause safety concerns
- All of the above (correct)
Which of the following is a potential disadvantage of moving towards continuous bioprocessing?
Which of the following is a potential disadvantage of moving towards continuous bioprocessing?
What are single-use systems in biomanufacturing primarily made of?
What are single-use systems in biomanufacturing primarily made of?
What is one advantage of using single-use systems in biomanufacturing?
What is one advantage of using single-use systems in biomanufacturing?
What is the purpose of running the sample through the same type of column several times in continuous chromatography?
What is the purpose of running the sample through the same type of column several times in continuous chromatography?
Which of the following is a reason why continuous bioprocessing is being explored as a future manufacturing method?
Which of the following is a reason why continuous bioprocessing is being explored as a future manufacturing method?
In continuous bioprocessing, what occurs in upstream bioprocessing?
In continuous bioprocessing, what occurs in upstream bioprocessing?
What is the advantage of using continuous chromatography in protein purification?
What is the advantage of using continuous chromatography in protein purification?
