From Manual R&D to GMP-Compliant [⁶⁸Ga]Ga-MAA Production

How CHU de Brest turned a manual R&D method into a GMP-compliant, multicentre-ready production process, built around an on-cassette purification step available only from Trasis.

Why Injectable [⁶⁸Ga]Ga-MAA Production Is Challenging

Pulmonary perfusion imaging with ⁶⁸Ga-MAA promises what ^99mTc scintigraphy cannot: PET-grade resolution, regional lung function delineation, quantifiable images.

The obstacle was never the isotope.
It was making the product injectable.

Macroaggregates cannot be sterile-filtered. The particles are far too large to pass a sterilising-grade membrane. The conventional route to a sterile injectable is closed from the outlet.
Losing sterile filtration does not mean losing purification: by using an original process of [⁶⁸Ga]Ga-MAA purification, residual stannous chloride and unaggregated albumin, which competes with the particles for ⁶⁸Ga and clouds the images with background signal, would otherwise stay in the vial that goes into the patient.
A manual, operator-dependent method can hinder the implementation of multicentre trial: ensuring reproducibility across sites is more challenging. Moreover, the number of synthesis would be limited by dosimetry of the operators.

The Trasis Solution: Automated [⁶⁸Ga]Ga-MAA Purification with a Sterile Single-Use Cassette

Trasis solved the sterility problem by producing a sterile single-use cassette. By using this cassette, sterile buffer and materials, the operator is able to produce a sterile suspension of [⁶⁸Ga]Ga-MAA. Developed by Trasis in collaboration with Brest radiopharmacy, the [⁶⁸Ga]Ga-MAA could be purified immediately after the labelling step. This step separates the labelled macroaggregates from residual stannous chloride and unaggregated albumin, without a single manual manipulation.

Because the chemistry, the cassette and the reagent kit were co-developed as one product, the sequence is qualified with every GMP-approved ⁶⁸Ge/⁶⁸Ga generator on the market, so adopting it does not force a centre to change generator supplier.

That is also why it scales: a new centre receives a qualified process, not a protocol to reproduce. Ten French centres now run PEGASUS II. For most of them [⁶⁸Ga]Ga-MAA are performed on the identical sequence, cassette and reagent kit. These centres didn’t need to redevelop the chemistry.

Standardized sterile cassettes enabling purification of the final product are a key for multicenter clinical trials, ensuring GMP compliant radiopharmaceutical preparation across sites while simplifying implementation and reducing site-to-site variability.

Dr. Blanc-Béguin & Prof. Le Roux

CHRU de Brest

Ga-MAA Clinical Trials and Multicentre Deployment

A GMP-compliant [⁶⁸Ga]Ga-MAA production process, robust enough for human injection, running on AllinOne and miniAllinOne synthesizers.
IMPD submitted and first clinical trials launched.
PETEP: [⁶⁸Ga]Ga-MAA for perfusion combined with ⁶⁸Ga-labelled carbon nanoparticles (Galligas) for ventilation for the diagnosis of pulmonary embolism. 100 patients between 2019 and 2024.
PEGASUS: [⁶⁸Ga]Ga-MAA for perfusion to plan lung stereotactic body radiotherapy. 60 patients, >150 scans in 2021-2022.
The objective is that PEGASUS II will be deployed across 10 French centres, on the same qualified process.
Sharper images. Functional lung tissue spared more precisely in stereotactic radiotherapy. That is why this programme exists.

A Qualified Automated [⁶⁸Ga]Ga-MAA Process on AllinOne and miniAllinOne

Everything you would otherwise have to build already exists:

An automated process with a [⁶⁸Ga]Ga-MAA final purification step that contributes to make the product injectable, available only on a sterile Trasis cassette.
The sterile consumables and reagent kit, manufactured at clinical volume.
The automated sequence, qualified on every GMP-approved generator, running on AllinOne and miniAllinOne.

By saving you from having to solve the sterility, purification, reproducibility and regulatory problems yourself, Trasis helps your programme reach patients faster.

From manual R&D to automated [68Ga]Ga-MAA production for lung perfusion PET/CT

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