Automated QC: Improving capacity in radiopharmacy
19 September 2024
At a glance
> The growing demand for a diversifying range of radiopharmaceuticals is presenting challenges for existing PET suppliers with bottlenecks in production.
> The automation of Quality Control presents significant improvements in both production capacity and regulatory compliance, while still offering savings in cost and labour, as discussed in our latest video with Sales Director Elvir Zahirovic.
> Tracer-QC is an automated, single-instrument system designed to address production constraints that has already been approved for clinical use by a European regulator.
What are the challenges facing radiopharmaceutical QC?
As the demand for medical imaging and cancer treatments continues to grow, the production and diversification of radiopharmaceuticals faces challenges. Bottlenecks in production, especially for novel radiotracers, could prospectively restrict supply with significant implications for clinical care.
A key area for innovation is Quality Control (QC), where traditional methods rely heavily on skilled technicians manually operating multiple instruments to carry out a range of different analytical tests. This process is slow, resource-intensive, and susceptible to human error, which limits the ability to scale production.
Tracer-QC is designed specifically to address this.
Automated QC at the touch of a button
Automation in QC is not only a solution – it’s a necessity to meet the growing demand for radiopharmaceuticals. Tracer-QC is a fully automated system that supersedes traditional QC methods by condensing the entire process into a streamlined single-instrument platform, allowing operators to conduct multiple tests with the simple touch of a button.
For existing PET producers, this means increased production capacity without the need for additional staff, equipment, or bench space. Automating the QC process for high-volume tracers such as 18F-FDG frees up resources that can be allocated toward the production of novel tracers, which often require more complex handling.
Introducing efficiency and productivity gains
One of the biggest advantages of adopting Tracer-QC is the efficiency and productivity gains it can provide producers with. Moving from manual methods into fully automated testing operated by 21 CFR Part 11-compliant software eliminates the potential for human error and ensures complete traceability of records. Furthermore, this automation simplifies validation efforts and reduces ongoing costs, as traditional QC is labour-intensive.
In addition to increasing throughput, Tracer-QC reduces a laboratory’s equipment footprint by replacing the series of instruments typically required for QC with a single system. It also provides greater standardisation by reducing SOPs, ensuring consistency and compliance across different production sites.
Proven Success with regulatory approval in Europe
Tracer-QC’s capabilities have already been demonstrated. At Haukeland University Hospital in Norway, twelve analytical methods using Tracer-QC were validated and approved by the Norwegian Medical Products Agency (DMPA) for the QC of 18F-FDG. This milestone marks a significant step forward in demonstrating the reliability and efficacy of the system. Additionally, the International Medical Center in Egypt has been successfully using the system to release 18F-FDG for patient administration.
As the radiopharmaceutical industry continues to expand, the pressure to keep pace with demand will only grow. Tracer-QC offers a path forward, allowing existing PET producers to scale their operations, reduce human error, and standardise QC procedures, while minimising costs and increasing productivity.
Find out more
You can learn more about Tracer-QC by clicking the button below to speak to a product specialist directly.