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
GMP Quality Control
& Release Testing.
We perform sterility testing using membrane filtration in compliance with Ph. Eur. 2.6.1 and USP <71>. The method is suitable for products with short half-lives and high activity levels and ensures reliable detection of microbial contamination under GMP conditions.
We determine visible and sub-visible particles to ensure compliance with particle-related quality requirements. Testing supports patient safety and batch release of sterile products.
We support the development of radiolabelling of your active substances (e.g. small molecules, peptides, antibodies) and analyse radiochemical purity (RCP), radiochemical yield (RCY) as well as potential by-products — including full chemical and microbiological quality control to support a GMP-compliant final product.
Method-Development, Validation
& Risk Assesment.
We perform product-specific analytical and process validations, including sterility testing validation for automated systems. This supports regulatory compliance and dossier submissions across development stages.
We assess extractables and leachables from packaging and process contact materials. Studies include impurity profiling and evaluation of potential impact on product safety and stability.
We offer highly sensitive screening and validated quantification of nitrosamines in APIs, formulations and materials. Our methods support regulatory risk assessments, including challenging matrices.
Analytical Technologies
for handling short-lived and high-activity samples.
We apply HPLC methods to determine content, purity and degradation products. Methods are GMP-compliant and adapted to product-specific requirements.
Using LC-MS/MS, we identify and quantify trace-level impurities, including nitrosamines and extractables. The technique enables highly sensitive and selective analysis in complex matrices.
Gas chromatography is used for the analysis of volatile compounds and residual solvents. Measurements are performed under controlled conditions suitable for high-activity samples.
We determine elemental and metal impurities using ICP-MS. The method is adapted to radioactive matrices and ensures compliance with applicable regulatory limits.
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
