Free CABP Practice Questions

Question 1

A dual-target CAR T-cell product is designed to kill leukemia cells through either CD19 or CD22 recognition independently. Its potency assay uses targets expressing both antigens. A development lot with a nonfunctional CD22-binding arm still passes. Which assay change would best reveal loss of either arm's activity?

Accepted Answer

Test CD19-only and CD22-only targets separately, with a double-negative control.

Answer

Increase the effector-to-target ratio against the existing dual-positive target cell line.

Answer

Measure total CAR surface expression on a larger sample of viable T cells.

Answer

Repeat testing on the same target line using a longer co-culture incubation period.

Question 2

On day 6 after CAR T-cell infusion, an adult is awake and has an Immune Effector Cell-Associated Encephalopathy (ICE) score of 5. A 90-second focal seizure resolves with treatment, and the patient promptly returns to the preceding awake state. There are no recurrent seizures, deep motor weakness, or cerebral edema, and evaluation finds no alternative cause. Using ASTCT criteria, what was the peak immune effector cell-associated neurotoxicity syndrome (ICANS) grade during this episode?

Accepted Answer

Grade 3, because the brief clinical seizure determines severity.

Answer

Grade 1, because the patient remains awake between neurological events.

Answer

Grade 2, because the ICE score lies between 3 and 6.

Answer

Grade 4, because any seizure after cellular therapy is life-threatening.

Question 3

Forty minutes into citrate-anticoagulated leukapheresis for CAR T-cell manufacture, a 10-year-old develops perioral tingling and hand cramps. Ionized calcium has fallen from 1.16 to 0.92 mmol/L. Blood pressure and oxygen saturation remain stable, without rash, wheezing, or fever. How should the collection clinician manage this episode?

Accepted Answer

Reduce citrate delivery and give protocol-directed calcium.

Answer

End the collection and reschedule it after symptoms resolve.

Answer

Give a saline bolus and increase inlet flow to finish sooner.

Answer

Give an antihistamine while maintaining the citrate delivery rate.

Question 4

At a lot-disposition meeting, an analyst says, 'The first potency result was 64%, but retests were 82% and 84%, so we can release.' The release minimum is 75%. System suitability passed, no assignable laboratory error was found, and the manufacturing investigation remains open. Which response to the analyst is appropriate?

Accepted Answer

The passing retests do not, by themselves, invalidate the original failure.

Answer

The lot meets potency because the mean of all three results exceeds the release minimum.

Answer

The initial result can be excluded because the two subsequent results agree with each other.

Answer

The two passing retests justify release with enhanced monitoring of the recipient after infusion.

Question 5

After erythroid-specific BCL11A enhancer editing, fetal hemoglobin rises even though the sickle HBB variant is unchanged. What accounts for the therapeutic effect?

Accepted Answer

The edit reduces erythroid BCL11A expression, reactivating gamma-globin without correcting the HBB mutation.

Answer

The edit replaces the sickle HBB sequence with a normal beta-globin gene.

Answer

A lentiviral vector adds a functional beta-globin gene alongside the patient's HBB variant.

Answer

The edit increases erythroid BCL11A expression, switching hemoglobin production from beta-globin to gamma-globin.

Question 6

A CAR T-cell developer is replacing serum-containing medium with a chemically defined medium. Historical lots vary widely in expansion and phenotype. A comparison using prespecified potency, phenotype, and viable-yield criteria must distinguish the medium's effect from donor variability and assess consistency across donors. How should the available starting material be allocated?

Accepted Answer

Split material from multiple donors between the two processes and compare paired results.

Answer

Manufacture new-medium lots from current donors and compare them with the historical lot averages.

Answer

Assign one donor to the existing medium and a different donor to the new medium.

Answer

Pool the donor material before dividing it between the two manufacturing processes.

Question 7

A cryopreserved cellular product arrives with one temperature alert. Its approved shipping specification is at or below -120°C; the early-warning alarm is set at -150°C. The calibrated probe beside the product records a warmest temperature of -138°C. The complete record is within the validated shipping duration, and identity and packaging checks pass. The receipt procedure permits acceptance after documented review when specifications are met. How should this shipment be handled?

Accepted Answer

Accept the shipment after documenting compliance with the approved transport specifications.

Answer

Reject the shipment because the logger recorded a temperature alert.

Answer

Require a viability retest before accepting the shipment.

Answer

Quarantine the product pending authorization for an exceptional release.

Question 8

A U.S. clinic proposes a clinical study of an unapproved product made by isolating a patient's adipose-derived cells, expanding them for several weeks, and infusing them intravenously to treat heart failure. The team argues that returning cells to the same patient permits regulation solely under section 361 of the Public Health Service Act. Which regulatory assessment applies to the proposed study?

Accepted Answer

The proposed study requires an IND; autologous origin does not exempt this product.

Answer

Section 361 is sufficient once the clinic registers its establishment and lists the cellular product.

Answer

The same-surgical-procedure exception applies because donor and recipient are the same individual.

Answer

Section 361 is sufficient if the clinic completes donor eligibility testing and the product passes sterility testing.

Question 9

Installation checks for a new controlled-rate freezer confirm its utilities, sensors, and software version. Empty-chamber operating runs and alarm challenges meet their predefined criteria. Before routine patient-product processing, which additional evidence best establishes that the freezer performs its intended function?

Accepted Answer

Demonstrate reproducible product freezing profiles under representative and worst-case loading conditions.

Answer

Document a second review of installation records and utility connections.

Answer

Show that a qualified freezer uses the same chamber-temperature program.

Answer

Obtain the manufacturer's factory testing certificate for this freezer model.

Question 10

A technologist is checking a two-bag progenitor-cell graft for a 70-kg recipient. Each bag contains 50 mL available for infusion. A validated assay reports 4.2 × 10^6 viable CD34-positive cells/mL in bag 1 and 1.4 × 10^6 viable CD34-positive cells/mL in bag 2; dead cells are excluded from both concentrations. Overall nucleated-cell viability is 75%. The order requires at least 3.5 × 10^6 viable CD34-positive cells/kg. What dose is available from both bags, and does it meet the order?

Accepted Answer

4.0 × 10^6 cells/kg; meets the prescribed minimum.

Answer

2.0 × 10^6 cells/kg; below the prescribed minimum.

Answer

3.0 × 10^6 cells/kg; below the prescribed minimum.

Answer

5.3 × 10^6 cells/kg; meets the prescribed minimum.

Free CABP Practice Questions

Domain 1: Biotherapies in the Patient Care Ecosystem 11% of exam

Question 1

Domain 2: Biotherapies Science and Ethics 9% of exam

Question 2

Domain 3: Operations and Equipment 19% of exam

Question 3

Question 4

Domain 4: Biotherapies Development Lifecycle 15% of exam

Question 5

Domain 5: Manufacturing 15% of exam

Question 6

Question 7

Domain 6: Quality Systems 21% of exam

Question 8

Question 9

Domain 7: Regulatory Environment 10% of exam

Question 10

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