October 14, 2018

TRASIS EUROPE | ONE MORE SUCCESS FOR TRASIS’ FDG DUAL MARKET AUTHORIZATION

Three months after its approval by the American FDA, Trasis’ FDG Dual method obtains its Market Authorization for Belgium and the Netherlands.

Trasis and Radboud Translational Medicine (RTM) worked together and finalized the Marketing Authorization National Phase for FDG production on AllinOne synthesizers.

This achievement is the result of a strong collaboration initiated a few years ago. This firstly consisted of providing reliable synthesizers allowing RTM to produce FDG back-to-back under GMP. Then, assisting them throughout the regulatory process to accelerate and complete a MA in the shortest possible time.

Lars Perk, PhD RTM Managing Director says ‘Obtaining the marketing authorization in a relatively short period of time is an important milestone for Radboud Translational Medicine (RTM). Construction of our facility was completed in December of 2015 and we have made great strides in the three years since then. Now, we are ready for the next step: delivering FDG to a wide range of hospitals in the Netherlands and Belgium’.

Today, Radboud Translational Medicine can rely on Trasis to ensure the necessary procurement of FDG Dual kits to provide hospitals through Belgium and the Netherlands, and hospitals in Germany will follow soon.

About FDG Dual kits by Trasis

[18F]FDG is used in PET for diagnosing, staging and monitoring treatment of cancers, particularly in Hodgkin’s disease, non-Hodgkin’s lymphoma, colorectal cancer, breast cancer, melanoma and lung cancer.

Cost-effective

With its high yield (70+-4%) Trasis FDG Dual process allows a significant reduction (-50%) of the total cost of production.

Perfomance

Cassette and reagents set up time < 1 min
Synthesis time 26 min
Synthesis yield 70 ± 4%
Radiochemical purity ≥ 98%

 

Product availability
Trasis provides all the necessary components to manufacture the [18F]FDG Dual within required conditions.

About Radboud Translational Medicine

Radboud Translational Medicine’s young team consists of enthusiastic employees who have earned their stripes in the (radio)pharmaceutical industry, science and medical imaging. Together, we are committed to the development of radiopharmaceuticals for use in daily medical practice and biomedical research.

About Trasis

At Trasis, our primary focus is allowing the medical community to access new radiolabeled therapeutic and diagnostic substances more easily and more quickly. To this end, we design, manufacture, sell and support high-performance synthesizers, dose preparation equipment, their shielding and accessories. We also develop customized synthetic methods and instruments. We can provide GMP Active Pharmaceutical Ingredients (API) and assist our customers with their regulatory affairs. Our proven radiopharmaceutical expertise, coupled with our high-end instruments, enable us to provide fully integrated solutions for an effective tracer production and faster transition from drug development to marketing authorization.