Eckert & Ziegler is an experienced partner for the development of PET tracers, kits and radiopharmaceuticals.
We offer a variety of services from pre-clinical development of radiopharmaceutical candidates to process design and scale-up with support through all clinical phases and commercial distribution.
As a provider of holistic solutions we can not only support you with extensive know-how and consulting but also with all the necessary equipment and infrastructure for your success.
Projects in early development and pre-clinical stages often require radiochemistry development support as well as Chemistry, Manufacturing, and Controls (CMC) expertise.
Based on specified biomolecules and radioisotopes we develop a robust radioconjugate and optimize it and the methods for manufacturing and testing it to define potential radiopharmaceuticals.
Based on a radiopharmaceutical or existing manual process we develop scalable, automated production solutions for clinical and industrial applications.
With our Modular-Lab radiosynthesis technology, we are able to customize equipment, disposable cassettes and software according to your needs. A suitable quality control standard can also be designed based on our radiochromatography portfolio.
We support your trials by providing multiple centres with equipment as well as customized software and consumables for the on-site production of your radiopharmaceutical candidate. This ensures easy, consistent and GMP-compliant handling of the product for reliable results. For industrial in-house manufacturing we offer dedicated equipment and infrastructure for GMP-production and easy scale-up.
Financial and regulatory risks lead to a high barrier of entry in the field of nuclear medicine. We offer companies without the necessary infrastructure the possibility to rent equipped space and experienced personnel for the completion of project milestones.
Our GMP clean rooms will be equipped according to your requirements with hot cells, radiosynthesis, quality control and further equipment.
Eckert & Ziegler successfully cooperated with Curium to establish STRIASCAN™’s production by providing a Modular-Lab PharmTracer system based on the specifications of the process and laboratory environment. We developed a special single-use cassette as well as an application design for the Modular-Lab Software. Additionally, we provided documentation for the qualification and risk analysis of the system and trained Curium’s employees in handling the system and software.
We rented out a GMP suite to Pentixapharm for their R&D work. We then assisted them in designing the fully automated production process for their lead investigational product. The process was established on our Modular-Lab platform and customized cassettes for on-site production are manufactured in our GMP clean room facilities. Today, we also act as a contract manufacturer for the production of their lead therapeutical candidate in our GMP laboratory in Berlin.