Atley C100

The world’s first and only commercial manufacturing system for At-211 radiopharmaceutcials

The Atley C100 is the world’s first and only commercial manufacturing system specifically designed for At-211 radiopharmaceuticals. This state-of-the-art platform addresses the critical challenges of At-211 radiopharmaceutical manufacturing, enabling reliable and scalable production from non-clinical R&D to full-scale commercial rollout. 

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Technology

The Atley C100 module delivers automated, standardized, and reproducible manufacturing of At-211 radiopharmaceuticals. Its process involves two key stages: purification of At-211 from irradiated targets through dry distillation, followed by automated radiopharmaceutical synthesis and purification.

Purification process:

Starting with an irradiated Bi-209 target, the Atley C100 efficiently purifies At-211 through a cutting-edge dry distillation process. The final elution step of the purification is highly flexible, allowing the use of different solvents to suit specific downstream radiochemistry processes. This purification process is completed in less than 30 minutes and achieves a non-decay-corrected yield of minimum 80%. The resulting At-211 solution contains minimal impurities, ensuring exceptional quality for subsequent synthesis steps.

Radiopharmaceutical synthesis & purification:

Automated radiolabeling in the Atley C100 uses a peristaltic pump and 3×5 valves to precisely dose reagents into a reactor vial. The reactor can be actively heated and agitated for optimal synthesis conditions. A position for a purification column equipped with an in-line radiodetector ensures final purification of the radiolabeled compound. The fully disposable fluid pathway enhances regulatory compliance and allows for a seamless transition from non-clinical to clinical manufacturing. Atley Solutions supplies all necessary consumables for use with the Atley C100.

Fact box: Atley C100

  • Patent-Protected: Across Europe, the United States, Japan, and China.
  • Regulatory Compliance: CE mark & CB certificate of compliance to IEC 61010-1.
  • Dimensions (W x D x H): 605 mm x 435 mm x 535 mm.
  • At-211 Purification Yield: >80% (n.d.c.).
  • At-211 Purification Time: <30 minutes.
  • Launch Year: 2024, with an installed base spanning three continents.

Safety

Operator safety is a cornerstone of the Atley C100’s design. The system is engineered to comply with international safety standards and minimize the risk of radiation exposure:

  • Under Pressure Operation: The system operates under negative pressure, ensuring that any leaks result in air being drawn into the module rather than radioactive material escaping.
  • Gas Filtration: All gases used or generated are routed through two activated carbon filters. The first is a single-use filter included in the consumable kit, while the second is a larger, built-in filter replaced during annual maintenance. Both filters are monitored with radiodetectors to identify trapped radioactive substances.
  • Closed Environment Operation: The Atley C100 must be operated within a glovebox or hot cell, providing an additional protective barrier between radioactive materials and the operator.