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Advancements in Biomanufacturing

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Questions and Answers

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?

Protein Concentration (correct)

Storage Temperature

Manufacturing Process

Packaging Material

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?

Reduced testing time Signup and view all the answers

What are single-use systems in biomanufacturing primarily made of?

Plastic Signup and view all the answers

What is one advantage of using single-use systems in biomanufacturing?

Reduced energy and water usage Signup and view all the answers

What is the purpose of running the sample through the same type of column several times in continuous chromatography?

To improve purity Signup and view all the answers

Which of the following is a reason why continuous bioprocessing is being explored as a future manufacturing method?

It saves time and money in the manufacturing process Signup and view all the answers

In continuous bioprocessing, what occurs in upstream bioprocessing?

Cells are scaled in a fed-batch bioreactor Signup and view all the answers

What is the advantage of using continuous chromatography in protein purification?

It allows for high yields and high resolution of the protein Signup and view all the answers