JBA Written Exam cheat sheet

Biosafety levels map to risk groups: BSL-1 (RG1, no disease), BSL-2 (RG2, moderate hazard), BSL-3 (RG3, aerosol-transmitted serious disease), BSL-4 (RG4, life-threatening, no treatment).

Directional airflow is from clean to contaminated zones; BSL-3/4 suites hold negative pressure differentials (typically -10 to -50 Pa) relative to corridors.

Biological safety cabinets: Class I = inward flow, no product protection; Class II = personnel + product + environment; Class III = gas-tight glovebox for BSL-4.

HEPA filters retain ≥99.97% of particles at 0.3 µm; BSL-3 exhaust HEPA is tested annually and after any structural change (decontamination or filter change).

Autoclave efficacy: 121 °C at 15 psi (103 kPa) for 15-30 min, or 134 °C for 3-4 min; validated with biological indicators (Geobacillus stearothermophilus spores).

Chemical disinfection: 70% ethanol for surfaces, 1:10 household bleach (0.5% sodium hypochlorite) for blood spills, 5-10% bleach for high-concentration organic spill; contact time 10-30 min.

Waste segregation: sharps into puncture-resistant containers; biohazard waste into red bags; liquid waste decontaminated before drain discharge; autoclave tape is a process indicator, not a sterilization guarantee.

Primary containment = cabinet/PPE; secondary containment = facility envelope, HVAC, waste systems. Both are required for BSL-3+ operations.

Risk assessment considers agent pathogenicity, infectious dose, transmission route, host range, availability of prophylaxis, and environmental stability (BSL classification by WHO/NIH).

Containment level is set by the highest-risk procedure, not the agent alone: aerosol-generating steps (centrifugation, vortexing, sonication) may require a higher BSL than routine handling.

Biosafety vs biosecurity: biosafety addresses accidental exposure; biosecurity addresses intentional misuse, theft, or diversion - both must be assessed.

Risk = likelihood × consequence; residual risk is assessed after controls are applied, and re-assessed when procedures, agents, or personnel change.

Aerosol-generating procedures require Class II BSC use; open-bench work is acceptable only for RG1/RG2 with no significant aerosol generation.

Spill response hierarchy: alert, evacuate, allow aerosol settle (≥30 min), don PPE, cover with absorbent, apply disinfectant, remove, decontaminate, report.

Personnel training, medical surveillance, and immunization (e.g., HBV, rabies) are part of the risk control plan for RG2/RG3 work.

Genetically modified organisms are assessed under the same framework; containment level may be raised if the modification increases virulence or environmental fitness.

Biological Resource Centers follow OECD Best Practice Guidelines and ISO 20387 (biobanking); key elements are accession, authentication, viability, and traceability.

Cell line authentication: STR profiling (human) or species-specific markers; misidentification is a leading cause of irreproducible research.

Mycoplasma contamination is detected by PCR or culture; routine screening every 1-3 months is standard for continuous cell lines.

Cryopreservation: slow cooling (~-1 °C/min) to -80 °C, then liquid nitrogen (-196 °C); DMSO 5-10% is a common cryoprotectant; viability on thaw should be ≥70-80%.

Seed lot and working stock systems: master seed and working seed lots are characterized once and used for production; passage number is tracked to limit genetic drift.

Quality control of culture media includes sterility, growth promotion, and pH checks; each lot is tested before use in production.

Inventory management requires unique identifiers, location mapping, and audit trails; a documented chain of custody is essential for regulatory acceptance.

Reference standards and controls must be traceable and periodically re-qualified; expired or degraded standards invalidate assay results.

ICH Q7 covers GMP for active pharmaceutical ingredients; ICH Q8-Q12 cover pharmaceutical development, quality risk management, quality systems, and lifecycle management.

GMP pillars: quality management, personnel, premises, equipment, documentation, production, quality control, contract manufacturing, complaints/recalls, self-inspection.

Data integrity ALCOA+: Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, Available.

21 CFR Part 11 governs electronic records and signatures: audit trails, access controls, and validation are required.

ISO 13485 applies to medical devices; ISO 9001 is generic quality management; ISO 17025 applies to testing/calibration laboratories.

Validation lifecycle: IQ (installation) → OQ (operation) → PQ (performance); process validation follows a three-batch approach under FDA guidance.

Change control and deviation management are mandatory; any change to process, equipment, or supplier requires documented impact assessment.

Pharmacopoeial standards (USP, EP, JP) define tests and acceptance criteria for compendial products; deviations require justification.

Central dogma: DNA → RNA → protein; PCR amplifies DNA exponentially (2^n after n cycles); qPCR quantifies starting template via Ct value.

CRISPR-Cas9 uses a guide RNA to target a complementary sequence adjacent to a PAM (e.g., NGG for SpCas9) and creates a double-strand break repaired by NHEJ or HDR.

Monoclonal antibodies are produced in CHO or hybridoma systems; upstream (bioreactor) and downstream (chromatography, filtration) define the process.

Bioprocess parameters: dissolved oxygen, pH, temperature, feed rate, and viable cell density; fed-batch and perfusion are the main modes.

Protein purification: affinity (Protein A) → ion exchange → size exclusion; purity assessed by SDS-PAGE and HPLC.

Vaccine platforms: live attenuated, inactivated, subunit, toxoid, mRNA, and viral vector; each has distinct cold-chain and safety profiles.

Enzyme kinetics: Michaelis-Menten v = Vmax[S]/(Km+[S]); Km is the substrate concentration at half-maximal velocity.

Biosimilars require analytical similarity, functional assays, and clinical comparability - not identical to the originator but highly similar.

QA is the system ensuring quality; QC is the testing function that verifies it; QA approves, QC measures - the two are organizationally independent.

Batch record review and release by the Qualified Person (EU) or authorized release (US) precedes distribution; no batch may be released without documented review.

Environmental monitoring (EM) in cleanrooms: viable and non-viable particle counts; Grade A/ISO 5 for critical zones; Grade B background for aseptic processing.

Cleaning validation demonstrates removal of product, cleaning agents, and microbes to predetermined limits; worst-case product and swab sites are selected.

CAPA (Corrective and Preventive Action) closes deviations; root cause analysis uses tools such as 5-Whys and fishbone diagrams.

Annual Product Quality Review (APQR) evaluates trends in batches, deviations, and complaints; required by EU GMP and expected by FDA.

Out-of-specification (OOS) results trigger a documented investigation; retesting is permitted only under a written, approved protocol.

Training records, SOPs, and change control form the documentary backbone of GMP; undocumented work is treated as not performed.

Institutional Biosafety Committee (IBC) reviews recombinant DNA and dual-use research; Institutional Review Board (IRB) reviews human-subjects research; IACUC reviews animal work.

Informed consent requires disclosure, comprehension, voluntariness, and capacity; it is a process, not just a signature.

Dual-use research of concern (DURC) is legitimate research that could be misused; oversight includes risk mitigation plans and publication review.

Environmental health and safety: hazard communication (SDS access), PPE selection, chemical fume hoods, and emergency eyewash/showers within 10 seconds' travel.

Waste hierarchy: reduce, reuse, recycle, treat, dispose; biohazardous waste must be decontaminated before leaving the facility.

Occupational exposure limits (OELs) and biological exposure indices guide worker protection; exposure monitoring is documented.

Whistleblower and non-retaliation protections apply to reporting of safety or compliance violations; retaliation is prohibited.

Sustainability in biotech includes solvent recovery, single-use plastic reduction, and energy-efficient HVAC; green chemistry principles (12 principles) guide process design.

BSL-2 requires handwashing sinks, autoclave access, and a biosafety manual; BSL-3 adds controlled access, sealed penetrations, and directional airflow.

BSC certification is performed at installation, after repair, and annually; the cabinet must be decontaminated (formaldehyde gas or VHP) before service.

Air changes per hour (ACH) in BSL-3 suites are typically ≥12; BSL-4 requires higher redundancy and HEPA on both supply and exhaust.

Autoclave load configuration affects penetration: bags and containers must allow steam contact; a Bowie-Dick test verifies air removal in porous loads.

Spill kit contents: absorbent, disinfectant, gloves, forceps, biohazard bags, and a written procedure; kits are checked on a defined schedule.

Signage at BSL-2+ doors states agent, biosafety level, responsible person, and required PPE; universal biohazard symbol is mandatory.

Pest control, restricted access, and visitor logging are facility controls that support biosecurity as well as biosafety.

A risk assessment is documented, dated, and reviewed at least annually or whenever a new agent, procedure, or personnel change occurs.

Infectious dose varies by route: inhalation often requires fewer organisms than ingestion; route-specific assessment guides PPE and engineering controls.

Sharps injuries are the leading exposure route in laboratories; safe sharps devices and no-recapping policies reduce risk.

Pregnant, immunocompromised, and immunized workers require individualized risk assessment; some agents (e.g., CMV, Toxoplasma) pose special fetal risk.

Decontamination validation uses biological indicators; chemical disinfectant efficacy depends on concentration, contact time, temperature, and organic load.

Biosecurity tiers: inventory control, access control, personnel reliability, and transport security; select agents require registration under national rules.

Post-exposure management includes first aid, reporting, medical evaluation, and prophylaxis (e.g., HIV PEP within hours).

ISO 20387:2018 specifies competence, impartiality, and consistency requirements for biobanks; accreditation is via a national body.

Sample quality metrics: pre-analytical variables (ischemia time, fixation), storage temperature, freeze-thaw cycles, and RNA integrity number (RIN).

Cell bank characterization includes identity, purity, sterility, mycoplasma, and adventitious agent testing (in vivo and in vitro).

Biological resource centers must have a documented succession and backup plan; cryogenic storage requires LN2 level monitoring and alarm systems.

Passage number limits are set in the master cell bank protocol; exceeding limits requires re-qualification or a new bank.

Contamination control in cell culture: aseptic technique, antibiotic-free cultures for detection, and quarantine of new lines.

Biospecimen traceability links donor consent, collection, processing, and distribution; consent scope limits downstream use.

EU GMP Annex 1 (2022 revision) sets contamination control strategy requirements for sterile products, including CCS documentation and PUPSIT considerations.

FDA 21 CFR 210/211 covers finished pharmaceuticals; 21 CFR 600 covers biologics; 21 CFR 820 covers medical devices (QSR).

ICH Q9(R1) quality risk management uses tools such as FMEA, HACCP, and risk ranking/filtering; risk-based decisions must be documented.

ICH Q10 establishes the pharmaceutical quality system across the product lifecycle: development, technology transfer, commercial, and discontinuation.

Stability testing (ICH Q1A) defines long-term, intermediate, and accelerated conditions; shelf life is supported by real-time data.

Registration pathways: IND/NDA/BLA (US), MAA (EU), and PMDA (Japan); each requires CMC, nonclinical, and clinical modules (CTD format).

Serialization and track-and-trace requirements (e.g., US DSCSA, EU FMD) apply to prescription products at the unit level.

Restriction enzymes cut at palindromic recognition sites; sticky ends ligate more efficiently than blunt ends; ligation requires compatible buffers and ATP.

Plasmid vectors carry an origin of replication, selectable marker, and multiple cloning site; transformation efficiency is reported as CFU per µg DNA.

Sanger sequencing uses chain-terminating dideoxynucleotides; next-generation sequencing uses massively parallel clonal amplification and short reads.

mRNA vaccines use lipid nanoparticles (LNPs) for delivery; the 5' cap and poly(A) tail improve stability and translation.

Bioprocess scale-up follows geometric and process parameters (tip speed, kLa, mixing time); scale-down models must be qualified.

Analytical methods for biologics: ELISA, surface plasmon resonance, mass spectrometry, and capillary electrophoresis for charge variants.

CRISPR off-target assessment uses computational prediction plus empirical assays (GUIDE-seq, CIRCLE-seq); HDR efficiency is lower than NHEJ.

Deviation classification: critical (patient safety/regulatory), major (product quality), minor (documentation); classification drives investigation depth.

Change control categories: minor, major, critical; critical changes require regulatory notification or prior approval before implementation.

Media fill (process simulation) qualifies aseptic filling; acceptance criteria are defined in Annex 1 and by the manufacturer's validated limits.

Supplier qualification includes audits, certificates of analysis, and quality agreements; critical suppliers are audited on a defined cycle.

Complaint handling and recall classification (Class I, II, III) are defined by health hazard; recall effectiveness checks are documented.

Validation master plan (VMP) lists all qualified systems and their status; periodic revalidation is triggered by change or trend.

ALCOA+ data integrity: audit trails must be enabled and reviewed; shared logins and backdating are prohibited.

Belmont Report principles: respect for persons, beneficence, and justice; these underpin modern human-subjects protections.

Declaration of Helsinki and CIOMS guidelines govern international research ethics; local law and ethics committee approval are both required.

Animal research follows the 3Rs (replacement, reduction, refinement); IACUC approval and humane endpoints are mandatory.

Conflict-of-interest disclosure is required for investigators, reviewers, and committee members; undisclosed conflicts can invalidate research.

Chemical safety: GHS classification and labeling; SDS sections 1-16; incompatible chemicals are stored separately.

Biological spill or exposure is a reportable event; root-cause analysis and corrective action follow, with records retained per regulation.

Environmental permits may be required for wastewater discharge, air emissions, and hazardous waste; exceedances trigger notification.

BSC airflow: 70% recirculated, 30% exhausted in Class II Type A2; Type B2 is 100% exhaust and is used with volatile chemicals.

Room pressure monitoring uses magnehelic gauges or sensors with alarms; loss of negative pressure is a reportable containment breach.

Decontamination of a BSL-3 room uses vaporized hydrogen peroxide or formaldehyde; efficacy is verified with biological indicators.

Emergency shower and eyewash stations are flushed weekly and inspected annually; access must be unobstructed.

Waste autoclave validation includes thermocouples in the load and biological indicators; cycle records are retained.

Facility commissioning includes airflow visualization (smoke test) and pressure decay testing of sealed rooms.

Risk group classification (WHO) is distinct from biosafety level: RG reflects agent hazard; BSL reflects the containment applied to the procedure.

Routes of exposure: inhalation, ingestion, percutaneous (sharps), and mucous membrane; controls are matched to route.

Aerosol-generating equipment includes centrifuges (use sealed rotors), blenders, and sonicators; these are operated in a BSC or closed system.

PPE selection: gloves (nitrile), gown, eye protection, and respiratory protection (N95/PAPR) based on risk assessment.

Waste and transport: UN packaging and triple containment for Category A infectious substances (UN2814); Category B is UN3373.

Biorisk management standard ISO 35001 provides a framework for laboratory biorisk management systems.

Cell line identity: STR loci for human lines; species-specific PCR or karyotyping for non-human lines; identity is confirmed at bank creation and after significant passage.

Viability assays: trypan blue exclusion and automated counters; viability below 70% may indicate poor cryopreservation or handling.

Adventitious agent testing includes sterility, mycoplasma, in vitro and in vivo assays, and retrovirus testing for rodent cell lines.

Sample storage: -80 °C for working aliquots, LN2 vapor for long-term; avoid repeated freeze-thaw; record freeze-thaw cycles.

Quality control of reference materials includes homogeneity, stability, and commutability assessment.

Documentation: chain of custody, informed consent, and material transfer agreements (MTAs) govern distribution.

GMP inspection types: routine, for-cause, and pre-approval; inspection findings are classified as critical, major, or minor (or FDA Form 483 observations).

Regulatory submissions use the Common Technical Document (CTD) format: Modules 1-5 (regional, quality, nonclinical, clinical).

ICH Q3A/Q3B set impurity limits for drug substances and products; ICH Q6A/B define specifications and test procedures.

Good Distribution Practice (GDP) requires temperature-controlled transport, qualification of shippers, and deviation handling.

Pharmacovigilance: adverse events are reported within defined timelines (e.g., 15 days for serious unexpected suspected adverse reactions in the EU).

Medical device classification (Class I-III in EU; Class I-III in US) drives conformity assessment and premarket submission requirements.

PCR cycle: denaturation (~95 °C), annealing (~55-65 °C), extension (~72 °C); primer Tm and Mg2+ concentration affect specificity.

qPCR quantification: standard curve (absolute) or ΔΔCt (relative); Ct is inversely proportional to starting template.

Protein expression systems: E. coli (fast, no glycosylation), yeast (glycosylation), CHO (human-like glycosylation), and insect cells (baculovirus).

Chromatography: affinity captures, ion exchange polishes by charge, size exclusion desalts and removes aggregates; resin lifetime is validated.

Biosimilarity assessment includes analytical, functional, nonclinical, and clinical comparability; extrapolation to other indications requires justification.

Gene therapy vectors: AAV (non-integrating, limited cargo), lentivirus (integrating), and adenovirus (transient, immunogenic).

Quality by Design (QbD): define quality target product profile (QTPP), critical quality attributes (CQAs), and critical process parameters (CPPs); design space is established in development.

Process validation stages (FDA 2011): Stage 1 process design, Stage 2 process qualification (PPQ), Stage 3 continued process verification (CPV).

Continued process verification uses statistical process control (SPC) charts and trend analysis to detect drift.

Cleaning validation acceptance limits: health-based exposure limits (HBEL/PDE) and visually clean criteria; rinse and swab sampling are both used.

Stability program: ongoing stability studies are required annually for at least one batch per product per year.

Self-inspection and quality audits are scheduled at defined intervals; findings are tracked to closure with CAPA.

Research misconduct: fabrication, falsification, and plagiarism (FFP); honest error and differences of opinion are not misconduct.

Authorship requires substantial contribution, drafting or critical revision, final approval, and accountability; ghost and gift authorship are prohibited.

Data privacy: GDPR and HIPAA govern personal and health data; de-identification and consent scope must be documented.

Biosafety and ethics oversight overlap in DURC review; publication of dual-use findings may require risk mitigation or redaction.

Environmental monitoring includes air, water, and soil sampling for facility emissions; results are compared against permit limits.

Occupational health surveillance includes pre-placement, periodic, and exit examinations for workers with hazardous exposures.

Biosafety cabinet placement: away from doors, drafts, and high-traffic areas; airflow disturbance reduces containment.

Class II BSC airflow alarm and sash alarm must be functional; the cabinet is not used if airflow is out of specification.

BSL-3 facility features: self-closing doors, sealed windows, HEPA-filtered exhaust, and a pass-through autoclave or dunk tank.

Decontamination of equipment before removal from containment uses a validated method (VHP, formaldehyde, or double-bagging with surface disinfection).

Emergency power and backup systems support HVAC, freezers, and alarms; generators are tested on a defined schedule.

Wastewater from BSL-4 must be heat-treated or chemically decontaminated before discharge.

Risk assessment documentation includes agent, titer, volume, procedure, route, controls, and residual risk; it is signed and dated.

Biological safety cabinets protect product and personnel but not from volatile chemicals unless ducted (Type B2) or fitted with a canopy.

Sharps policy: no recapping, no bending, no removal from syringes; disposal immediately after use into approved containers.

Spill outside the BSC requires evacuation and decontamination; spill inside the BSC is cleaned with the cabinet running.

Biosecurity inventory: select agents are tracked, secured, and inventoried; discrepancies are reported to authorities.

Post-exposure prophylaxis for HIV is most effective when started within hours; reporting and source testing follow protocol.

Cell bank tiers: master cell bank (MCB) and working cell bank (WCB); the WCB is prepared from the MCB and used for production.

Mycoplasma testing methods: culture (broth and agar) and PCR; PCR is faster but should be paired with culture for release.

Cryopreservation: controlled-rate freezing at ~-1 °C/min; DMSO toxicity is minimized by rapid dilution on thaw.

Sample quality: RIN ≥7 for RNA sequencing; DNA integrity assessed by gel or fragment analysis.

Biobank accreditation (ISO 20387) covers governance, quality, and technical competence; audits are periodic.

Material transfer agreements define permitted use, ownership, and redistribution; unauthorized sharing breaches the agreement.

FDA Form 483 lists inspectional observations; a Warning Letter can follow if responses are inadequate.

EU GMP Annex 1 requires a contamination control strategy (CCS) covering facility, equipment, personnel, and processes.

ICH Q11 covers development and manufacture of drug substances, including starting material selection and control strategy.

Stability: ICH Q1A defines long-term (25 °C/60% RH or 30 °C/65% RH), intermediate (30 °C/65% RH), and accelerated (40 °C/75% RH) conditions.

Serialization: US DSCSA requires unit-level traceability; EU FMD requires unique identifiers and tamper-evident seals.

Regulatory inspections may be announced or unannounced; access to records and facilities is a legal requirement.

Restriction enzyme nomenclature: organism abbreviation + strain + Roman numeral (e.g., EcoRI); recognition sites are often palindromic.

Transformation: competent cells are prepared by chemical (CaCl2) or electroporation; efficiency is reported as CFU/µg.

Sequencing: Sanger reads ~700-1000 bp; NGS short reads ~100-300 bp; long-read platforms improve assembly across repeats.

mRNA manufacturing: in vitro transcription, capping, polyadenylation, purification, and LNP encapsulation; dsRNA removal reduces immunogenicity.

Bioprocess: kLa (oxygen transfer) and mixing time are scale-dependent; scale-down models must reproduce these parameters.

Analytical: charge variants by capillary electrophoresis; aggregation by SEC; glycan profiles by HILIC.

Deviation investigation: contain, assess impact, identify root cause, implement CAPA, verify effectiveness, and close.

Change control: assess impact on regulatory filings, validation status, and product quality before approval.

Media fill acceptance: no contaminated units in the filled units; growth promotion of media is verified before use.

Supplier audits: critical suppliers audited every 1-3 years; audit reports and CAPA are tracked.

Recall classes: Class I (serious harm/death), Class II (temporary/reversible harm), Class III (unlikely harm).

Validation master plan and periodic review ensure qualified status of facilities, utilities, and equipment.

Belmont principles: respect for persons (autonomy), beneficence (maximize benefit, minimize harm), and justice (fair distribution).

Declaration of Helsinki: ethics committee review, informed consent, and risk minimization for human research.

3Rs: replacement (non-animal methods), reduction (fewer animals), refinement (less pain/distress); humane endpoints are defined in protocols.

Conflict of interest: financial and non-financial interests are disclosed and managed; undisclosed conflicts undermine trust.

GHS: pictograms, signal words, hazard statements, and SDS sections 1-16; incompatible chemicals stored separately.

Environmental permits: air, water, and hazardous waste; exceedances require notification and corrective action.

BSC certification uses NSF/ANSI 49 or EN 12469 standards; the cabinet is decontaminated before and after service.

Negative pressure differentials: BSL-3 suites typically -10 to -50 Pa relative to corridors; alarms alert on loss of differential.

HEPA filter testing: aerosol challenge (PAO or DOP) with photometer scan; leak testing is performed annually and after change.

Autoclave validation: thermocouples map load temperature; biological indicators confirm lethality; records retained.

Spill kits are checked monthly; contents include absorbent, disinfectant, PPE, and disposal bags.

Biosecurity: access control, visitor logs, and pest control support both biosafety and security.

Risk assessment is documented and reviewed annually or after any change in agent, procedure, or personnel.

Route of exposure determines controls: inhalation → BSC/respirator; percutaneous → sharps safety; ingestion → no mouth pipetting.

Aerosol-generating procedures include centrifugation, vortexing, and sonication; use sealed rotors and BSC.

PPE: gloves, gown, eye protection, and respiratory protection based on risk assessment; PPE is removed in a defined order.

Transport: Category A (UN2814) requires triple packaging and trained shippers; Category B is UN3373.

ISO 35001 provides a biorisk management system framework for laboratories.

Identity testing: STR profiling for human lines; species PCR or karyotyping for non-human lines.

Viability: trypan blue or automated counting; <70% viability suggests poor cryopreservation or handling.

Adventitious agent testing: sterility, mycoplasma, in vitro/in vivo assays, and retrovirus testing for rodent lines.

Storage: -80 °C for working aliquots, LN2 vapor for long-term; avoid repeated freeze-thaw.

Reference materials: homogeneity, stability, and commutability are assessed before use.

Documentation: chain of custody, consent, and MTAs govern distribution and use.

GMP inspections: routine, for-cause, and pre-approval; findings classified as critical, major, or minor (Form 483).

CTD modules: 1 regional, 2 quality, 3 nonclinical, 4 clinical, 5 references; used for IND/NDA/BLA and MAA.

ICH Q3A/Q3B impurity limits; Q6A/Q6B specifications and test procedures.

GDP: temperature-controlled transport, shipper qualification, and deviation handling.

Pharmacovigilance: serious unexpected suspected adverse reactions reported within 15 days (EU).

Device classification drives conformity assessment and premarket submission requirements.

PCR: denaturation ~95 °C, annealing ~55-65 °C, extension ~72 °C; primer Tm and Mg2+ affect specificity.

qPCR: standard curve (absolute) or ΔΔCt (relative); Ct is inversely proportional to starting template.

Expression systems: E. coli (no glycosylation), yeast, CHO (human-like), insect cells (baculovirus).

Chromatography: affinity capture, ion exchange polish, size exclusion for aggregates/desalting.

Biosimilarity: analytical, functional, nonclinical, and clinical comparability; extrapolation requires justification.

Gene therapy vectors: AAV (non-integrating, limited cargo), lentivirus (integrating), adenovirus (transient, immunogenic).

QbD: QTPP, CQAs, CPPs, and design space are defined during development.

Process validation stages: process design, process qualification (PPQ), continued process verification (CPV).

CPV uses SPC charts and trend analysis to detect drift.

Cleaning validation: HBEL/PDE limits, visually clean criteria, and rinse/swab sampling.

Ongoing stability: at least one batch per product per year is tested.

Self-inspection and audits: scheduled intervals, findings tracked to closure with CAPA.

Research misconduct: fabrication, falsification, and plagiarism (FFP); honest error is not misconduct.

Authorship: substantial contribution, drafting/critical revision, final approval, and accountability; ghost/gift authorship prohibited.

Data privacy: GDPR and HIPAA govern personal and health data; de-identification and consent scope documented.

DURC review overlaps biosafety and ethics; publication may require mitigation or redaction.

Environmental monitoring: air, water, and soil sampling compared against permit limits.

Occupational health surveillance: pre-placement, periodic, and exit examinations for hazardous exposures.