Biocontainment
Seven of our target pathogens are Risk Group 4 organisms: high case fatality, aerosol-transmissible in the laboratory, and with no vaccine or treatment available. We also work with five Risk Group 3 agents: rabies virus, Andes/Sin Nombre orthohantavirus, monkeypox virus, Rift Valley fever virus with arthropod containment, and Burkholderia pseudomallei as a Tier 1 select agent. This page explains what that means for how the work is done, where it is done, and who is allowed to do it, within the limits of what we publish about a facility that holds Category A material. Public revision 6 of 41. Nine sections, two tables and all floor plans are withheld.
- Why this work needs containment
- The four biosafety levels
- Pathogen reference table
- The Palm Coast containment facility
- The positive-pressure suit
- Entry and exit
- Our programmes inside containment
- Prions: a different problem entirely
- Decontamination and inactivation
- Waste, effluent and air
- Moving Category A material
- Exposure and incident response
- Oversight, registration and dual-use
- People, training and reliability
- Field deployment and outbreak response
- Glossary
- Section withheld
- Section withheld
Why this work needs containment
Most drug discovery does not involve anything that can kill the person doing it. Ours does. A programme against Nipah virus or Marburg virus requires live virus at some point — neutralisation assays, resistance selection, animal challenge studies, potency release testing — and there is no version of that work that is safe on an open bench.
The organising idea of biological containment is that the barrier should never be a single thing. It is layered. Primary containment keeps the agent away from the worker: a biological safety cabinet, a sealed centrifuge rotor, a suit. Secondary containment keeps the agent inside the building if primary containment fails: directional airflow, sealed room envelopes, airlocks, HEPA filtration, effluent treatment. Administrative controls decide who may enter, in pairs or alone, having slept how much, carrying what. No single layer is trusted, because every one of them has failed somewhere.
The classification that drives all of this is the risk group of the organism, which considers four things: how severe the disease is, how readily it spreads in a community, whether effective treatment or prophylaxis exists, and the risk to the individual worker. Risk Group 4 is the category for agents that are highly lethal, transmissible, and untreatable. Nipah, Marburg, Sudan ebolavirus, Crimean-Congo haemorrhagic fever virus, Lassa virus, Junín virus and Machupo virus are all in it; Sabiá and Guanarito are also Risk Group 4 agents. There are only a few dozen laboratories in the world cleared to work with these organisms.
The four biosafety levels
Biosafety level describes the facility and the practice. Risk group describes the organism. They usually line up, but not always — a Risk Group 3 organism may be handled at BSL-2 for non-propagative diagnostic work, and a Risk Group 2 organism may be handled at BSL-3 if the procedure generates aerosol.
| Level | Typical agents | Primary barrier | Facility | Practice |
|---|---|---|---|---|
| BSL-1 Risk Group 1 |
Agents not known to cause disease in healthy adults — non-pathogenic E. coli K-12, Bacillus subtilis | Open bench; standard microbiological practice | Sink, door, cleanable surfaces | Lab coat, gloves, eye protection as needed. No special ventilation. |
| BSL-2 Risk Group 2 |
Agents causing treatable human disease — Salmonella, hepatitis B, influenza A seasonal strains, SARS-CoV-2 non-propagative | Class II biological safety cabinet for aerosol-generating steps | Self-closing lockable door, autoclave available in the building, eyewash | Restricted access, biohazard signage, sharps controls, decontamination of all waste. |
| BSL-3 Risk Group 3 |
Agents causing serious disease that may be treatable — M. tuberculosis, West Nile virus, yellow fever, SARS-CoV-2 propagative, rabies virus | Class II or III cabinet for all open manipulation; sealed rotors and safety cups | Two doors in series, single-pass air, negative pressure, non-recirculating exhaust, sealed penetrations, on-site autoclave | Respiratory protection, gowning and degowning, medical surveillance, buddy or check-in system, entry log. |
| BSL-4 Risk Group 4 |
Agents causing severe, often fatal disease with no vaccine or treatment — Nipah, Marburg, Sudan ebolavirus, Lassa, Crimean-Congo haemorrhagic fever, Junín and Machupo; Sabiá and Guanarito are also Risk Group 4 | Class III cabinet line (“glovebox” suite) or full-body air-fed positive-pressure protective suit | Dedicated building or isolated zone, airlocks, chemical shower, double HEPA on exhaust, decontaminated effluent, redundant power and air supply, monitored pressure cascade | Two-person rule, full change of clothing, chemical shower on exit, immunisation and surveillance programme, incident drills. |
Prion work sits outside this ladder. It is normally performed at containment level 2 or 3 depending on the tissue and species, but under prion-specific inactivation and instrument rules, because the agent is not inactivated by the methods the ladder assumes. See prions below.
Pathogen reference table
The organisms relevant to our portfolio, with the ones we are actively developing against marked. Case fatality figures are the ranges reported in the published outbreak literature and vary widely with outbreak size, strain and available supportive care.
| Pathogen | Disease | Family | Reservoir & route | Case fatality | Containment | Baxtra programme |
|---|---|---|---|---|---|---|
| Nipah virus | Henipavirus encephalitis and acute respiratory syndrome | Paramyxoviridae | Pteropus fruit bats; raw date-palm sap, intermediate livestock, person to person | 40–75% | BSL-4 | BX-101 · Phase 1 |
| Hendra virus | Hendra virus infection | Paramyxoviridae | Flying foxes via horses | ~57% (small numbers) | BSL-4 | BX-101 · secondary |
| Marburg virus | Marburg virus disease | Filoviridae | Egyptian rousette bats; contact with blood and body fluids, nosocomial amplification | 24–88% | BSL-4 | BX-204 · Phase 1 |
| Ravn virus | Ravn virus disease | Filoviridae | As Marburg | High, few recorded events | BSL-4 | BX-204 · covered |
| Zaire ebolavirus | Ebola virus disease | Filoviridae | Bat reservoir suspected; contact transmission | 25–90% | BSL-4 | BX-204 · secondary |
| Sudan ebolavirus | Sudan ebolavirus disease | Filoviridae | Contact transmission | ~41–70% | BSL-4 | BX-806 · Phase 1 |
| CCHF virus | Crimean-Congo haemorrhagic fever | Nairoviridae | Hyalomma ticks, livestock slaughter, patient blood | 10–40% | BSL-4 | BX-412 · Phase 1 |
| Junín virus | Argentine haemorrhagic fever | Arenaviridae | Rodent reservoir; contact with infected excreta | Variable | BSL-4 | BX-1265 · Phase 1 |
| Machupo virus | Bolivian haemorrhagic fever | Arenaviridae | Rodent reservoir; contact with infected excreta | Variable | BSL-4 | BX-1265 · Phase 1 |
| Lassa virus | Lassa fever | Arenaviridae | Mastomys rodents; excreta, person to person | ~1% overall, 15–20% hospitalised | BSL-4 | BX-515 · Phase 1 |
| Andes/Sin Nombre orthohantavirus | Hantavirus cardiopulmonary syndrome | Hantaviridae | Rodents; Andes virus has confirmed person-to-person spread | ~35–40% | BSL-3 | BX-733 · Phase 1 |
| Rabies virus | Symptomatic rabies encephalomyelitis | Rhabdoviridae | Bite of an infected mammal | ~100% once symptomatic | BSL-3 | BX-620 · Phase 1 |
| Monkeypox virus | Clade I mpox | Poxviridae | Close contact with lesions, body fluids or contaminated materials | Variable | BSL-3 | BX-1140 · Phase 1 |
| Rift Valley fever virus | Severe Rift Valley fever | Phenuiviridae | Mosquitoes and contact with infected animals or tissues | Variable | BSL-3 + arthropod containment | BX-1330 · Phase 1 |
| Burkholderia pseudomallei | Melioidosis | Burkholderiaceae | Contaminated soil or water; inhalation, ingestion or inoculation | Variable | BSL-3; Tier 1 select agent | BX-1620 · Phase 1 |
| Prions (PrPSc) | Creutzfeldt–Jakob disease and related | Not an organism | Sporadic, inherited, or iatrogenic via CNS tissue and instruments | ~100% | CL2/3 + prion practice | BX-308 · Phase 1 |
The Palm Coast containment facility
We commissioned our own containment suite rather than contracting the work out. The reason is not prestige. A programme that has to ship samples to somebody else’s suit laboratory and wait for a slot in their schedule moves at their speed, and an assay that takes three days of bench time takes eleven weeks of calendar time. Building it ourselves cost roughly a fifth of the R&D spend to date and bought back about nine months on each of three programmes.
The suite occupies a structurally independent zone of the Palm Coast campus with its own foundation, its own electrical service and its own air handling. Nothing shares a duct, a drain or a conduit with the rest of the building. Access to the zone itself — before any laboratory door — is card and biometric, logged, and limited to twenty-two people. The names of those people are not published and will not be released on request. Two of the twenty-two are not employees of Baxtra.
A second containment facility, referred to internally as Facility 2, supports this programme. Its location, operator and specification are not disclosed in this revision. The section of this page that described it was removed on 14 July 2026 and the two paragraphs that referred to it have not been rewritten.
Commissioning was completed in July 2026 and independently verified: pressure cascade under fault conditions, HEPA filter in-place integrity by aerosol challenge, chemical shower interlock behaviour on power loss, breathing-air quality and reserve duration, effluent thermal cycle validation with biological indicators, and a full-scale casualty extraction drill with the county emergency service present.
Verification is repeated annually and after any change to the envelope, the control system or the exhaust train.
Floor plans, the room schedule, the pressure cascade diagram and the utility and security drawings were published in an earlier revision of this page and have been withheld since 14 July 2026. The reason is physical security. They will not be republished. The photographic tour of the suite was removed on 21 August 2026 after nine days.
Facility specification
- BSL-4 suit laboratory — 210 m² across four rooms plus animal holding
- BSL-3 laboratories — 640 m², six suites, independently isolatable
- Pressure cascade — −25 Pa, −50 Pa, −75 Pa, −100 Pa from corridor to the innermost room, continuously monitored and alarmed
- Air changes — 15 per hour, single pass, no recirculation anywhere in the zone
- Exhaust — two HEPA filters in series, bag-in bag-out housings, in-place scan-testable
- Supply air — single HEPA with backdraft protection and bubble-tight isolation dampers
- Envelope — welded stainless and epoxy seamless surfaces, all penetrations sealed and pressure-decay tested to a specified leak rate
- Breathing air — redundant oil-free compressors on separate feeders, plus a 30-minute reserve receiver and individual escape cylinders
- Effluent — all liquid waste heat-inactivated in a validated batch cook cycle before it may enter the sanitary sewer
- Power — utility feed, standby generator with 72 hours of fuel, and UPS covering controls, alarms and exhaust
- Pass-through — double-door autoclave, dunk tank and vaporised hydrogen peroxide airlock
- Controls — air-gapped building management system, no external network route, with local and remote alarm annunciation
The suit, item by item
- One-piece encapsulating suit in chemically resistant laminate, positive pressure throughout
- Umbilical air line from a ceiling-rail manifold, delivering roughly 250–300 litres of HEPA-filtered breathing air per minute
- Positive internal pressure of a few millibars, so any breach leaks outward and not inward
- Panoramic welded visor, anti-fog treated
- Integral boots plus a second overboot changed between rooms
- Two pairs of gloves: an inner surgical pair taped to the cuff, an outer heavy pair changed on any suspicion of damage
- Escape cylinder giving several minutes of independent air if the umbilical fails
- Whole-suit pressure-decay leak test before every entry, and a documented visual inspection after every exit
The positive-pressure suit
A BSL-4 suit is not protective clothing in the ordinary sense. It is a portable containment envelope with a person inside it, and the person is the least reliable component. Air is fed in continuously through a hose from an overhead rail so that the inside of the suit is always at slightly higher pressure than the room. That is the whole principle: if the suit is punctured, air goes out rather than agent coming in, and the wearer has time to reach the shower.
The consequences of the design are practical and constant. The suit is loud — the air rush makes normal conversation impossible, so work is done with hand signals, whiteboards and intercom. It is hot, and a four-hour entry is the maximum we permit. The gloves remove almost all tactile feedback, so pipetting, tube handling and animal work are slower and every sharp is a serious hazard rather than a nuisance. The umbilical constrains where you can stand. Everything takes about three times as long as it would on an open bench, and the protocols are written on that assumption rather than fighting it.
People who work in the suite train in it for months before they handle anything live, and every entry is in pairs, with a third person outside monitoring on camera and intercom who has the authority to order an exit and does not need to explain themselves.
Entry and exit
The sequence below is the shape of a normal working entry. Every step is logged and the whole cycle takes about forty minutes of the working day before any science happens.
Authorisation and fitness
Confirm the day’s work is on the approved protocol list, that both entrants are current on training and medical surveillance, and that neither reports illness, sleep deprivation, or any condition or medication that would make the entry unwise. Anyone may stand themselves down without giving a reason.
Complete change
All personal clothing, jewellery and personal effects are removed and left outside the barrier. Dedicated scrubs are issued. Nothing crosses the line that does not have to.
Suit checks
Visual inspection of the suit, then a pressure-decay leak test. Gloves are taped. The suit is connected to the air rail and inflation confirmed before the inner door is opened.
Airlock and cascade
Entry through interlocked doors that cannot both be open. The pressure differential display is read and recorded at each stage. If the cascade is out of specification the entry stops.
The work
Open manipulation in a Class II cabinet, centrifugation in sealed safety cups opened only in the cabinet, no glass where plastic will do, and no sharp unless there is no alternative. Everything is called out loud to the partner and to the observer outside.
Chemical shower
Exit is through a timed chemical shower that decontaminates the outside of the suit while it is still inflated and still being worn. The cycle cannot be shortened and the outer door will not release until it has completed.
Doff, shower, sign out
The suit is removed, inspected and hung for service. A personal shower follows, then the entry log is closed with time in, time out, work performed, and any deviation however small. Deviations are reviewed weekly whether or not anything came of them.
Our programmes inside containment
What actually gets done behind the airlock, programme by programme. Chemistry, formulation, analytical work and all clinical supply manufacture use no infectious material and happen in the ordinary laboratories. The twelve programme fact sheets are available in the document library.
BX-101 · Nipavir — Nipah virus
BSL-4 · Phase 1 SENTINEL-1 · case fatality 40–75%
Live-virus neutralisation against Bangladesh and Malaysia genotypes and against Hendra virus; syncytium inhibition assays in primary endothelial cells; resistance selection by serial passage under drug pressure to map escape mutations in the F glycoprotein; and efficacy studies in the Syrian hamster and African green monkey models, which is where the Animal Rule evidence comes from. Everything that involves replication-competent virus is in the suit laboratory. The pseudovirus and structural work is not, and is done at BSL-2.
Programme detailBX-204 · Marburavir — Marburg virus
BSL-4 · Phase 1 CORDON-1 · case fatality 24–88%
Potency determination against Marburg, Ravn, Zaire and Sudan isolates; polymerase incorporation and chain-termination biochemistry using recombinant L protein, which is BSL-2 work; deep sequencing of passaged virus to confirm the high barrier to resistance we expect from a lethal-mutagenesis mechanism; and non-human primate challenge studies with delayed treatment start, because a treatment that only works if given before symptoms is not a treatment for an outbreak.
Programme detailBX-412 · Cehafex — CCHF
BSL-4 · Phase 1 BASTION-1 · case fatality 10–40%
Neutralisation of clinical isolates spanning the Europe, Asia and Africa clades; epitope mapping and confirmation that escape at one epitope leaves the second antibody fully active; Fc effector function assays; and challenge studies in the interferon-deficient mouse and the cynomolgus macaque. Antibody manufacture, characterisation and release testing involve no virus and sit in normal facilities.
Programme detailBX-308 · Prionex — CJD
Containment level 3 with prion practice · Phase 1 VIGIL-0 · ~100% fatal
Real-time quaking-induced conversion assays on patient cerebrospinal fluid; prion protein quantification to support the pharmacodynamic endpoint; and transgenic mouse bioassay of infectivity, which is slow because prion incubation periods are measured in months. This work does not need a suit, but it needs single-use instruments, dedicated equipment that never leaves the room, and sodium hydroxide inactivation for anything that must be reused.
Programme detailAdditional clinical-stage programmes
| Candidate | Target disease | Approach | Containment | Stage |
|---|---|---|---|---|
| BX-515 | Lassa fever | IV GPC-B site human monoclonal antibody | BSL-4 | Phase 1 TRAVERSE-1 |
| BX-620 | Symptomatic rabies encephalomyelitis | CNS-penetrant lyssavirus L-polymerase inhibitor, IV + intrathecal loading dose | BSL-3 | Phase 1 LANTERN-1 |
| BX-733 | Hantavirus cardiopulmonary syndrome | Selective S1PR1 agonist and host-directed endothelial stabiliser | BSL-3 | Phase 1 RIDGELINE-1 |
| BX-806 | Sudan ebolavirus disease | IV two-antibody cocktail | BSL-4 | Phase 1 KEYSTONE-1 |
| BX-1140 | Clade I mpox | Second-generation p37 (F13L) envelope inhibitor | BSL-3 | Phase 1 MERIDIAN-1 |
| BX-1265 | South American haemorrhagic fevers | Pan-arenavirus GP2 fusion inhibitor | BSL-4 | Phase 1 CROSSBAR-1 |
| BX-1330 | Severe Rift Valley fever | Fixed antibody and bunyavirus L-polymerase inhibitor pair | BSL-3 + arthropod containment | Phase 1 HEADWATER-1 |
| BX-1620 | Melioidosis | Efflux-pump-inhibitor-potentiated beta-lactam | BSL-3; Tier 1 select agent | Phase 1 REDLAND-1 |
Eight additional disclosed clinical-stage programmes are listed here. Programme 9, the thirteenth clinical-stage programme, is not described and is omitted deliberately.
Prions: a different problem entirely
Everything above assumes an organism — something with a genome, a metabolism, and a protein coat that heat and chemicals can wreck. A prion has none of those. It is the body’s own prion protein, folded wrongly, and its only activity is to impose that same misfold on normal copies it touches. There is nothing to kill.
The consequences are strange and expensive. Prions survive standard autoclaving at 121°C. They survive ethanol, formaldehyde, ionising radiation, dry heat and most disinfectants. They bind tightly to stainless steel and remain infectious after the instrument has been cleaned by normal means, which is how iatrogenic Creutzfeldt–Jakob disease has been transmitted by neurosurgical instruments and depth electrodes. There is no serological test for exposure and no post-exposure prophylaxis, and the incubation period can be decades.
So prion practice is not about air pressure. It is about never generating an aerosol you cannot account for, never reusing anything you do not have to, and treating central nervous system tissue as the highest-risk material in the building even though the organism does not need a suit.
Prion-specific practice
- Single-use instruments for all CNS tissue wherever possible, incinerated after use
- Where reuse is unavoidable: immersion in 1N sodium hydroxide, then a 134°C gravity steam cycle held for an extended period — conventional cycles are not sufficient
- Disposable, sealed work surfaces; no shared equipment leaves the designated room
- Formic acid treatment of fixed tissue before histology
- No sharps in the same session as CNS tissue handling unless unavoidable and double-witnessed
- Incineration as the default waste route rather than autoclaving
- Exposure is documented and the individual is entered into long-term follow-up, because there is no test that could reassure them sooner
This is why BX-308 is a substrate-reduction drug. There is no pathogen to inhibit, so the only pharmacological handle is the supply of normal prion protein.
Decontamination and inactivation
Different agents die to different things, and the method has to be validated for the agent, the load and the surface — not assumed.
| Method | Used for | Notes and limitations |
|---|---|---|
| Steam autoclave · 121°C, saturated | Routine solid waste, glassware, media, animal bedding | Effective against all our viral agents. Cycle validated by thermocouple and biological indicator on the worst-case load, not the easy one. Not reliable for prions. |
| Extended steam · 134°C, prolonged hold | Prion-contaminated reusable items | Used in combination with sodium hydroxide immersion. Single method alone is not accepted. |
| 1N sodium hydroxide | Prion-contaminated surfaces and instruments | Long contact time. Corrosive; incompatible with aluminium and some steels. |
| Sodium hypochlorite · typically 1:10 fresh dilution | Spills, surfaces, dunk tanks | Rapidly inactivates enveloped viruses. Degrades in light and with organic load, so it is made fresh and the organic load is removed first. |
| Vaporised hydrogen peroxide | Whole-room and cabinet fumigation, pass-through airlocks | Material-compatible and leaves no residue. Requires sealing and cycle development per room. Verified with chemical and biological indicators. |
| Chemical shower | Outside of the suit on every exit | Timed, interlocked cycle; cannot be shortened or bypassed. |
| Thermal effluent treatment | All liquid waste leaving the containment zone | Batch cook-and-hold at validated temperature and time before discharge. Every batch is recorded; failed batches recook. |
| Incineration | Animal carcasses, prion material, anything that cannot be validated another way | Chain of custody documented from the room to the furnace. |
Waste, effluent and air
Solid waste
Nothing leaves the containment zone as waste without passing through the double-door autoclave or the fumigation airlock. The double-door design means the clean side can only be opened after a successful cycle, so a failed run cannot be unloaded into the corridor by mistake. Loads are indicator-tested and the records are held for the life of the programme.
Liquid effluent
Every drain in the zone — sinks, showers, floor gullies, the chemical shower itself — runs to dedicated effluent tanks that share nothing with the site sewer. Waste is heat-treated in batches, held, sampled and only then discharged. The tanks have containment bunding sized for the largest single tank plus margin.
Air
Supply air is HEPA-filtered and the exhaust passes two HEPA filters in series, in bag-in bag-out housings so filters can be changed without exposure. Filters are scan-tested in place, not just certified by the manufacturer. Exhaust fans are duplicated with automatic changeover and sit on the standby generator and UPS, because the one state the building must never enter is positive pressure.
Moving Category A material
Shipping a high-consequence pathogen is regulated as dangerous-goods transport, not as laboratory work, and the rules are unforgiving. Cultures of Nipah, Marburg and CCHF virus are Category A infectious substances, assigned UN 2814 — infectious substance affecting humans — and must travel under packing instruction P620.
That means triple packaging: a leakproof primary receptacle, a leakproof secondary packaging, and a rigid outer packaging, with absorbent material sufficient to take the entire liquid contents and an itemised list between the secondary and outer layers. The complete package is design-tested to survive a 9-metre drop, puncture, stacking and pressure differential. The outer surface carries the infectious substance label, the UN number and proper shipping name, and the responsible person’s 24-hour contact number.
Beyond the packaging: the shipper must be trained and certified, the receiving laboratory must hold the appropriate registration and must have agreed to receive the material in advance, an import or transfer permit is usually required, and the carrier must accept Category A — most do not. We move as little as possible, and we would rather run an assay in our own suite than ship an isolate anywhere.
Category A at a glance
- UN 2814 — infectious substance affecting humans
- P620 — triple packaging, design-tested
- Absorbent capable of taking the full liquid volume
- Itemised contents list inside the outer packaging
- Trained and certified shipper; documented refresher training
- Pre-arranged, registered recipient
- Permits and prior notification as required by both jurisdictions
- 24-hour emergency contact on the package
- Chain of custody recorded from bench to carrier to recipient
Category B (UN 3373) covers diagnostic and clinical specimens that are not cultures and carries much lighter requirements. The distinction matters and is decided by the biosafety officer, not by the person packing the box.
Exposure and incident response
The premise is that an incident will happen eventually, and the only question is whether the response is rehearsed. Every scenario below has a written plan and is drilled at least annually.
| Event | Immediate action | Follow-up |
|---|---|---|
| Suit breach or glove tear | Announce to the partner and the observer, cover the breach, move directly to the chemical shower, complete the full cycle | Occupational health assessment the same hour, exposure classified, quarantine or active surveillance per the agent, formal incident report within 24 hours |
| Sharps injury | Do not remove the suit in the laboratory. Controlled exit through the chemical shower with the partner escorting | Wound management, agent-specific risk assessment, isolation decision, contact tracing of the entry party |
| Spill inside primary containment | Leave the cabinet running, cover with absorbent, apply fresh hypochlorite, allow full contact time before clearing | Surface verification, review of the procedure that produced the spill, retraining if the cause was technique |
| Spill outside primary containment | Stop work, hold the room, evacuate the entry party through the shower, seal the room | Room fumigation with vaporised hydrogen peroxide, indicator verification, re-entry only after clearance by the biosafety officer |
| Loss of pressure cascade | Automatic alarm; standby exhaust fan starts; entry party exits under the controlled procedure; no new entries | Engineering root cause, re-verification of the cascade under fault conditions before the suite is returned to service |
| Breathing air failure | Switch to the escape cylinder, exit immediately via the shower with the partner | Compressor and reserve system investigation, drill review, air quality re-certification |
| Medical emergency inside the suite | Casualty extraction plan: the partner initiates, the observer summons the response team, the casualty is decontaminated in the suit before removal | Handover to emergency services at a designated point, using the agreed protocol rehearsed with the county service |
| Suspected inventory discrepancy | Immediate suspension of work with the affected material and notification of the responsible official | Reconciliation against the inventory record, formal reporting to the regulator within the required window |
Any laboratory-acquired infection or potential exposure is reported to the regulator, to the institutional biosafety committee, and disclosed in our annual transparency report, whether or not disclosure is legally required.
Oversight, registration and dual-use
Nothing about this work is done on our own authority. Possession, use and transfer of several of these agents is federally regulated, and the facility, the inventory and the named individuals are all registered. Work is approved agent by agent and protocol by protocol before any material is ordered.
Internally, the institutional biosafety committee reviews every protocol and includes members from outside the company who can and do refuse things. The responsible official has the authority to suspend any programme without consulting the executive, and reports to the board rather than to research leadership, which is the only arrangement under which that authority means anything.
We also apply a dual-use research of concern policy. Certain categories of experiment — anything that could enhance transmissibility or virulence, confer resistance to a countermeasure, or alter host range — are not performed, are not funded, and are not subcontracted. Where a legitimate scientific question falls close to that line, it goes to external review before it goes to the bench, and some questions we simply leave unanswered.
Governance stack
- Federal select agent registration for the entity, the space and each named individual
- Security risk assessment and personnel suitability screening before access
- Institutional biosafety committee with external members and published minutes
- Institutional animal care and use committee review for every animal study
- Responsible official with unilateral suspension authority, reporting to the board
- Dual-use research of concern policy with a prohibited-experiment list and external review
- Annual third-party audit of containment, inventory and records
- Inspection readiness maintained continuously rather than prepared for
- FDA Animal Rule (21 CFR 314 Subpart I) for most programmes; BX-733, BX-1620 and the mpox indication of BX-1140 use conventional 505(b)(1) routes because those diseases produce enough annual cases to enrol a randomised controlled trial
People, training and reliability
Containment is engineering plus people, and the engineering is the easy half. Twenty-two people are cleared for the suit laboratory — that is the public figure, and it is the figure we will give to any enquiry. Getting there takes between four and nine months depending on the role, and nobody skips it.
Training runs in stages: biosafety theory and agent-specific risk; supervised BSL-2 and BSL-3 practice; suit familiarisation with no material present, repeated until movement, signalling and the umbilical stop being distracting; full protocol rehearsal with a surrogate organism; then supervised live work with a mentor present for a defined number of entries. Competence is reassessed annually and after any extended absence.
Medical surveillance covers pre-placement assessment, immunisation where a vaccine exists, a baseline serum sample banked for every worker, and confidential occupational health access that does not route through a line manager. There is a two-person rule for every entry, a four-hour maximum, and a documented right for anyone to stand an entry down without giving a reason and without any consequence. Fatigue and distraction are treated as hazards on the same footing as a broken filter, because the failure mode they produce is the same.
We publish our lab-acquired infection count annually. It is currently zero, and we do not treat that as evidence that the system works — only that it has not yet been tested.
The near-miss register is maintained in full and published in part. Two entries from the current year are withheld pending review; both involved personnel, neither involved a release, and neither is a lab-acquired infection. This is stated so that the zero above is not read as covering more than it does.
Field deployment and outbreak response
A countermeasure that only exists in a freezer in Florida is not a countermeasure. Nipah, Marburg and CCHF outbreaks are short, remote and unpredictable: by the time a cluster is confirmed, a study that has not already been written, reviewed and approved cannot enrol anybody. Preparedness is therefore a design requirement rather than a later phase.
- Pre-approved protocols. Outbreak-response protocols for BX-101, BX-204, BX-308, BX-412, BX-515, BX-620, BX-733, BX-806, BX-1140, BX-1265, BX-1330 and BX-1620 are written, ethically reviewed, and pre-positioned with the relevant health authorities, so activation is a decision rather than a submission.
- Formulation for the field. BX-101 is oral; BX-412 is a single infusion with a 26-day half-life; BX-204 has an oral step-down. Each was chosen so the regimen can be delivered by a district hospital without an inpatient bed or a cold chain we cannot guarantee.
- Stability. Ongoing testing at 40°C and 75% relative humidity, because the storage conditions in the places these diseases occur are not the ones on the label.
- Stockpile-ready presentation. Unit-dose packaging designed for deployment kits rather than pharmacy shelves.
- Regional capability. Technology transfer discussions for regional fill and finish, so supply does not depend on a single site on another continent.
- Emergency access. A standing pathway for expanded access and emergency use requests from treating physicians, described on the patients page.
Glossary
| Term | Meaning |
|---|---|
| Aerosol-generating procedure | Any step — vortexing, sonication, centrifugation, pipetting forcefully — that can put small droplets into the air, which is where most laboratory-acquired infection comes from. |
| Airlock | A small room with interlocked doors that cannot both be open at once, preserving the pressure difference between two zones. |
| Animal Rule | 21 CFR 314 Subpart I. Allows efficacy to be established in animal studies where human efficacy trials would be unethical or infeasible. Most programmes use this pathway. BX-733, BX-1620 and the mpox indication of BX-1140 use conventional 505(b)(1) routes because those diseases produce enough annual cases to enrol a randomised controlled trial. |
| Biological safety cabinet | Primary containment at the bench. Class II protects the worker, the product and the environment with HEPA-filtered laminar airflow. Class III is a sealed, gas-tight glovebox. |
| Category A / Category B | Transport classifications for infectious substances. Category A (UN 2814) is material capable of causing permanent disability or life-threatening disease; Category B (UN 3373) is everything else. |
| Case fatality rate | The proportion of diagnosed cases that die. Distinct from infection fatality rate, which includes mild and undetected infections and is usually lower. |
| Chemical shower | Timed decontamination of the outside of a suit, performed while it is still worn and still inflated, on every exit from BSL-4. |
| Containment level | The facility and practice standard, as opposed to risk group, which describes the organism. Usually matched, occasionally not. |
| DURC | Dual-use research of concern. Legitimate research that could be misapplied to cause harm. Governed by a written policy with a prohibited-experiment list. |
| Effluent decontamination | Thermal or chemical treatment of all liquid leaving a containment zone before it reaches the sewer. |
| HEPA filter | High-efficiency particulate air filter, removing at least 99.97% of 0.3 µm particles. Two in series on BSL-4 exhaust, scan-tested in place. |
| Nosocomial transmission | Infection acquired in a healthcare setting. The dominant amplification route for filoviruses and CCHF. |
| Pressure cascade | Stepped negative pressure from the outside of a facility to its most hazardous room, so air always flows inward. |
| Primary / secondary containment | Primary is the barrier at the bench (cabinet, sealed rotor, suit). Secondary is the building (airflow, envelope, airlocks, filtration). |
| Prion | A misfolded form of a normal host protein that templates its own misfolding. No genome, no metabolism, and resistant to standard sterilisation. |
| PrPC / PrPSc | The normal cellular prion protein and its disease-associated misfolded form. BX-308 lowers the former, which is the substrate the latter requires. |
| Reservoir host | The species that maintains a pathogen in nature without severe disease — fruit bats for henipaviruses and filoviruses, Mastomys rodents for Lassa. |
| Risk group | Classification of an organism by severity, transmissibility and availability of treatment. Risk Group 4 is the most hazardous. |
| Select agent | A pathogen or toxin whose possession, use and transfer are federally regulated, requiring registration of the entity, the space and each individual. |
| Spillover | Transmission of a pathogen from its animal reservoir into humans — the starting event for nearly every outbreak on this page. |
| Syncytium | A mass formed when a virus fuses neighbouring cells together. Central to how Nipah virus destroys endothelium, and the reason BX-101 targets fusion. |
| Two-person rule | No one enters or works in maximum containment alone, with a third person monitoring from outside who can order an exit. |
| VHP | Vaporised hydrogen peroxide. Room and equipment fumigation that leaves no residue and is verified with chemical and biological indicators. |
The diseases behind the containment
Twelve disclosed programmes address Nipah, Marburg, Crimean-Congo haemorrhagic fever, Creutzfeldt–Jakob disease, Lassa fever, symptomatic rabies, hantavirus cardiopulmonary syndrome, Sudan ebolavirus disease, clade I mpox, South American haemorrhagic fevers, severe Rift Valley fever and melioidosis. None has an approved treatment.