GMP for Biological Products: appling the concepts #2(Ansan Cam.)

GMP for Biological Products: appling the concepts #2(Ansan Cam.)

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Question 1 of 2

1. Question
Which of the below phases is wrong?
- Transgenic is an organism that contains a foreign gene in its normal genetic component for the expression of biological pharmaceutical materials;
- A Working Cell Bank is prepared from a heterogeneously mixed pool of cells;
- Retention Sample is a sample of a fully packaged unit from a batch of finished product.
- Primary content is a system of containment that prevents the escape of a biological agent into the immediate working environment.
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Question 2 of 2

2. Question
Which of the sentences below DO NOT represent a challenge in manufacturing local vaccines:
- high failure rate of preceding efforts;
- high cost and time required to establish complex processes, and capabilities for production of a broad portfolio of vaccines;
- fragmented or inconsistent demand;
- harmonized regulatory requirements;
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