Reference no: EM133416395

Questions

1. Mark the process inputs that influence cell doubling rates (Mark all that apply)

1 Mononculear cell isolations

2 Cell seeding density

3 Medium type

4 Medium change schedule

5 Passage confluence

2. Critical quality attributes (CQAs) for mesenchymal stromal/stem cells (MSCs) as a representative of cell therapy include all of the following except:

1 Safety

2 Identity

3 Potency

4 Proliferative capacity

5 Purity

3. Cell surface markers are differentially expressed by different cell types and at different stages of differentiation. Therefore, cell surface markers are commonly assessed to determine the _____ of cell therapy products.

1 safety

2 genomic stability

3 identity

4 age

5 sterility

4. Dr. Jekyll wants to improve the potency of his final MSC therapeutic product. What process improvements might increase potency? (Mark all that apply)

1 Improve the cellular potency by stimulation

2 Direct the differentiation of the cell population

3 Increase the number of cell passages before inducing changes to achieve therapeutic potential

4 Determine expressed genes or secreted proteins that can be used to assay the potency of the product

5 Optimize the cell expansion methods

5. Before a stem cell-based therapy can be used for clinical therapy it must be subject to the following checks by a regulatory agency and/or independent committee: (Mark all that apply)

1 determination of cost and revenue potential

2 prospective review

3 ongoing monitoring

4 approval

6. Dr. Phil is concerned that two donor samples of MSCs have been mixed into one sample. Which of the following assays would best help him determine if this were the case?

1 flow cytometric analysis of MSC-specific cell surface antigens

2 miRNA expression

3 HLA expression

4 morphology staining

7. Which of the following government agencies oversees the regulatory component of cellular therapies?

1 CDC

2 FDA

3 FACT

4 USDA

8. When considering safety, which of the following adjustments to the manufacturing process of a cell therapy are typically used to limit the risk of contamination by microbial agents? (Mark all that apply)

1 Using a functionally closed culture system.

2 Eliminating animal products

3 Using antibiotics in the cell media

4 filtering the cells

9. In regards to animal welfare, what are the principles of the three Rs? (Mark all that apply)

1 reassign primate models to rodent models

2 replace animals with in vitro or non-animal experimental platforms

3 refine protocols

4 reduce replication experiments

5 reduce numbers.