Pharma

The isotope supply chain is fragile

Nuclear medicine depends on a handful of aging research reactors: when one goes down, entire countries run out of isotopes for diagnosis and cancer therapy. New, distributed production sources are needed, but a human-use isotope must be born in a GMP-validated facility, with a chain of custody documented from fission to the administered dose.

FORGE production reactor

FORGE configured for target irradiation and controlled-flux medical isotope production. The production cycle is repeatable and validatable batch by batch.

CORTEX GMP validation

CORTEX holds nuclear requirements and pharmaceutical GMP together in a single quality system. Every deviation is worked up in the same flow that the GMP inspector and the nuclear authority can audit.

LEDGER dose traceability

LEDGER tracks the chain of custody from target irradiation to the product batch, with decay time logged at each handoff. Provenance stays verifiable across a supply chain that runs against the clock.

AEGIS facility licensing

AEGIS manages the dual authorization, nuclear and pharmaceutical, keeping both dossiers aligned over the facility's life. A process change updates both licenses in the same step.

Isotope portfolio

We define target isotopes, clinical demand and the GMP requirements that drive the reactor configuration.

Validated facility

We build the facility and complete dual validation, nuclear and GMP, with AEGIS and CORTEX on one quality system.

First batch

We produce and release the qualification batches, with LEDGER documenting the chain of custody from fission to dose.

Steady production

We move to routine production, with distributed capacity that cuts dependence on the legacy reactors.

Aligned dual authorization

AEGIS keeps the nuclear and pharmaceutical dossiers aligned over the facility's life: a process change updates both licenses in the same step, with neither left behind.

Chain of custody against the clock

LEDGER tracks provenance from target irradiation to product batch with decay logged at each handoff, keeping verifiable a supply chain where the isotope loses value by the hour.

Auditable GMP quality

CORTEX works up every deviation in one flow auditable by both the GMP inspector and the nuclear authority, under EMA/FDA guidelines and radiation-protection standards, for products destined for human use.

Facility radiation protection

Flux control and containment of irradiated targets to radiation-protection standards and national nuclear authority requirements, with production repeatable and validatable batch by batch.

Why is the isotope supply chain considered fragile?

Nuclear medicine depends on a handful of aging research reactors: when one goes down, entire countries run out of isotopes for diagnosis and cancer therapy. The program builds new, distributed production capacity to break that dependence.

How is dual nuclear and GMP compliance managed?

CORTEX holds nuclear requirements and pharmaceutical GMP together in one quality system, so every deviation is worked up in the same flow that both the GMP inspector and the nuclear authority can audit. AEGIS keeps the two license dossiers aligned.

How do you trace an isotope that decays quickly?

LEDGER records the chain of custody from target irradiation to product batch with decay time at each handoff, so provenance stays verifiable across a supply chain that runs against the clock to the administered dose.

Is production repeatable and validatable?

Yes. FORGE is configured for controlled-flux target irradiation, with a production cycle repeatable and validatable batch by batch, as required for a human-use isotope in a GMP facility.