Leading the way
in Complex Pharmaceutical Analysis.
Your trailblazer for the safe and rapid development, approval and quality control of pharmaceuticals: As a contract laboratory and strategic partner, we are there for you from start to finish - in accordance with GMP/FDA standards and for all complex pharmaceuticals from biologics to vaccines.
Select range!
Together for a better future.
We support start-ups and manufacturers of next generation pharmaceuticals on their path to excellence.
With our comprehensive range of services, we ensure the safe and rapid development, approval and quality control of modern pharmaceuticals. Find out more about what is important to us.
The powerful partner by your side.
From Biologics to Vaccines.
We like it complex.
When things get complex, that's when things really get going for us. Whether biologics, orphan drugs, radiopharmaceuticals, or targeted therapeutics: We are your competent partner for all aspects of their analysis.
RADIOSTER.
Specific analysis in the field of microbiology and analytical chemistry for radiopharmaceuticals.
View into radioster
Our expertise in radiopharmaceuticals
at a glance.
We filter your radiopharmaceuticals through a microbe-retentive membrane and incubate the filters to ensure the absence of contamination. This method meets Ph. Eur. 2.6.1 / USP <71> requirements, even for high-activity products with short half-lives.
We perform product-specific validations of automated sterility testing to confirm method suitability for your formulation. This ensures regulatory compliance and supports dossier submissions.
We carry out the development of radiolabelling of your active substances (e.g., small molecules, peptides, antibodies) and analyze radiochemical purity, yield, and potential by-products. Full chemical and microbiological quality control is included to support GMP-compliant final products.
We assess which substances may migrate from packaging or container materials into your radioactive formulations. This includes impurity profiling and evaluation of potential impacts on product safety and stability.
We characterize and quantify both visible and sub-visible particles in your radiopharmaceuticals. This ensures conformity with particle-related quality requirements and supports patient safety.
We identify and quantify potentially carcinogenic nitrosamines specifically in radioactive APIs, formulations, and materials. Our highly sensitive methods are designed for hot matrices and support robust regulatory risk assessments for radiopharmaceuticals.
Using gas chromatography, we analyze volatile compounds, identity, purity, and residual solvents in radioactive samples. All analyses are performed under conditions suitable for handling short-lived and high-activity products.
We determine elemental and metal impurities in hot radiopharmaceutical products using ICP-based techniques. The analyses are tailored to radioactive matrices while ensuring compliance with applicable regulatory limits.
Our HPLC methods provide precise data on content, purity, and degradation products in radioactive active substances and finished products. All analyses are GMP-compliant and specifically adapted for radiopharmaceutical applications.
Are you a CDMO / CMO looking for an analytical laboratory
that can offer hot and cold analyses?
We offer in-process control and release analysis for your radioactive and classical products.
- Leachables / extractables with LC-MS, GC-MS, GC-DER
- Heavy metal impurities with ICP-MS
- Bioburden / sterility testing
- Hold-time studies
- CCIT (Container Closure Integrity Test)
moving images in THE MOVING IMAGE: WHAT WE DO.
Quality
meets requirements.
We guarantee uncompromising transparency and safety to the highest standards. To significantly improve the lives of cancer patients and people with rare diseases.
Our demand and goal:
scientific excellence.
We give everything with passion and expertise. To help patients and redefine the status quo. Every day, together with you.
Our daily motivation:
the human being.
Your patients are our patients. We want to work with you to ensure that these people benefit from our joint success.
customer voices
CUP Contract Labs is our key vendor for radiopharmaceutical analyses.
Work hard, play hard.
The perfect playground for experts:
Improve the lives of people with difficult to cure diseases with state-of-the-art technologies and plenty of opportunities.
Insights
into our working environment.
our Laboratories in radeberg
