JBA Written Exam flashcards

32 cards. Read the term and the definition here. The deck at the top of this page is optional.

BSL-4 containment

Highest containment level for life-threatening agents with no available treatment; requires positive-pressure suits or Class III cabinets, dedicated air systems, and strict access control.

HEPA filter efficiency

High-efficiency particulate air filters retain at least 99.97% of particles at 0.3 micrometers; they are tested annually and after any structural change.

Autoclave biological indicator

Geobacillus stearothermophilus spores are used to validate steam sterilization; growth indicates cycle failure, while no growth confirms lethality.

Directional airflow principle

Air moves from clean to contaminated zones; BSL-3 and BSL-4 suites are held at negative pressure relative to corridors to prevent escape of aerosols.

Class II biosafety cabinet

Provides personnel, product, and environmental protection through partial recirculation and HEPA filtration; used for RG2 and RG3 work involving aerosols.

Risk group versus biosafety level

Risk group classifies agent hazard; biosafety level describes the containment applied to a procedure. A high-risk agent handled safely may still require a higher BSL for aerosol-generating steps.

Aerosol-generating procedure

Any activity such as centrifugation, vortexing, or sonication that creates airborne particles; it requires a biosafety cabinet or closed system to prevent inhalation exposure.

Biosafety versus biosecurity

Biosafety addresses accidental exposure and contamination; biosecurity addresses intentional misuse, theft, or diversion of biological materials through access and inventory controls.

Spill response sequence

Alert and evacuate, allow aerosols to settle, don PPE, cover with absorbent, apply disinfectant with contact time, remove and decontaminate, then report and document.

Dual-use research of concern

Legitimate research that could be misused to pose a significant threat; oversight includes risk mitigation plans and review before publication.

STR cell line authentication

Short tandem repeat profiling compares a cell line's DNA profile to a reference; it detects misidentification and cross-contamination, a major source of irreproducible research.

Mycoplasma contamination testing

PCR and culture methods detect mycoplasma in cell cultures; routine screening every one to three months is standard for continuous cell lines.

Master and working cell banks

A characterized master cell bank is prepared once; working banks are derived from it for production, with passage number tracked to limit genetic drift.

Cryopreservation cooling rate

Cells are cooled at about minus one degree Celsius per minute to -80 Celsius, then stored in liquid nitrogen; DMSO at 5-10% is a common cryoprotectant.

ISO 20387 biobank standard

Specifies competence, impartiality, and consistency requirements for biobanks; accreditation is granted by a national accreditation body after assessment.

ALCOA+ data integrity

Records must be Attributable, Legible, Contemporaneous, Original, and Accurate, plus Complete, Consistent, Enduring, and Available; audit trails must be enabled and reviewed.

ICH Q7 scope

Good manufacturing practice guidance for active pharmaceutical ingredients; it covers quality management, personnel, premises, documentation, production, and quality control.

21 CFR Part 11

US regulation governing electronic records and signatures; requires validated systems, audit trails, access controls, and documented signature attribution.

Validation lifecycle IQ OQ PQ

Installation qualification verifies correct installation; operational qualification verifies function across ranges; performance qualification verifies performance under actual conditions.

EU GMP Annex 1

Sets contamination control strategy requirements for sterile products, including facility design, personnel, environmental monitoring, and aseptic process simulation.

CRISPR-Cas9 mechanism

A guide RNA directs Cas9 to a complementary sequence adjacent to a PAM; the resulting double-strand break is repaired by NHEJ or homology-directed repair.

qPCR Ct value

The cycle at which fluorescence crosses a threshold; Ct is inversely proportional to starting template, so lower Ct indicates more target nucleic acid.

Michaelis-Menten kinetics

The rate equation v equals Vmax times substrate concentration divided by Km plus substrate; Km is the substrate concentration at half-maximal velocity.

Monoclonal antibody production

Antibodies are produced in CHO or hybridoma systems; upstream bioreactor culture and downstream chromatography and filtration define the manufacturing process.

mRNA vaccine delivery

Lipid nanoparticles encapsulate mRNA; the 5-prime cap and poly(A) tail improve stability and translation, while dsRNA removal reduces immunogenicity.

Biosimilar comparability

A biosimilar is highly similar to an originator biologic but not identical; approval requires analytical, functional, nonclinical, and clinical comparability data.

QA versus QC

Quality assurance is the system that ensures quality and approves release; quality control is the testing function that measures conformance. They are organizationally independent.

CAPA process

Corrective and preventive action closes deviations; root cause analysis uses tools such as 5-Whys and fishbone diagrams, followed by effectiveness verification.

Out-of-specification investigation

An OOS result triggers a documented investigation; retesting is permitted only under a written, approved protocol, and the original result is retained.

Environmental monitoring cleanrooms

Viable and non-viable particle counts are monitored; Grade A or ISO 5 applies to critical zones, with Grade B background for aseptic processing.

Institutional Biosafety Committee

Reviews recombinant DNA and dual-use research, assesses containment, and ensures compliance with biosafety requirements before work begins.

Three Rs animal research

Replacement, reduction, and refinement guide humane animal research; protocols require IACUC approval and defined humane endpoints.